Vertex

Vertex Boston, MA, USA
Aug 23, 2019
Full time
Job Description: The Sr. Manager, GCP Audit and Inspection Management Quality Assurance is responsible for the oversight and execution of quality audit activities related to clinical trial execution, including audits of GCP CRO compliance, contributing to and executing audit plans, supporting inspection readiness activities, etc. Vertex is an exciting, fast paced dynamic environment with a strong company culture focused on patients with unmet medical needs. The ideal candidate is someone who is not afraid to dive in and help this expanding team. Position may require up to 30% national/international travel. Key Responsibilities: * Develops, maintains, and executes Audit Plans, supporting Clinical Studies/Programs * Conducts Clinical Vendor, Clinical Investigator and Clinical Document Audits * Provides oversight for audits that are outsourced * Executes directed or For-Cause GCP audits, as needed * Engages in Preparation, Support and Follow-up activities for Inspection Readiness * Provides regulatory compliance support & guidance to cross functional clinical study teams, as requested * May serve as GCP Quality Management System representative * Participates in collaborative review of impacted SOP/WI * Reviews and analyzes key Performance Indicator data and trends * Analyzes risk and proposes remedial, corrective and /or preventive actions * May participate on process improvement initiatives * Provides cross-functional support across the QA team #LI-SO1 Qualification: * M.S. (or equivalent degree) and 7+ years of relevant work experience, or * B.S. in a scientific or allied health field (or equivalent degree) and 10+ years of relevant work experience, or relevant comparable background In-depth knowledge in the following areas: * Clinical Audit processes * GCP Quality Systems * Global GCP regulations (US/EU etc.); ICHE6 R2, 21 CFR Part 50, 54, 56, 312, 314, and high level knowledge of 21 CFR Part 11 and International equivalents as necessary * Clinical Documentation (e.g., Investigator's Brochures, Clinical Study Reports, Protocols, etc.) * Investigation, Root Cause Analysis, CAPA and Effectiveness check processes, tools, and techniques * Risk management principles and process, change management * Phases 1-4 clinical trial within the drug development life cycle and regulatory requirements, best practices, industry standards
Vertex Boston, MA, USA
Aug 23, 2019
Full time
Job Description: Reporting to Senior Vice President, Finance, the Vice President, Corporate Finance is a critical and highly visible role that will help to drive, build, and scale the company's corporate finance organization. The Vice President, Corporate Finance will be responsible for overseeing all Corporate Finance activities including budgeting, forecasting, financial reporting, and analytics for the Board, Executive Committee and Functional leadership. The role/function has significant enablement responsibility with an emphasis on forward-looking planning and analysis while also providing governance and overseeing consistent execution. Leadership Responsibilities * Leads the Corporate Finance function by establishing a vision, supported by a clear road-map with objectives and measures of success. This role sets the tone for the group and organizes the team to efficiently achieve goals through delegation and accountability. * Viewed by the Executive Committee as an enterprise-level thinker, with a solid understanding of Vertex's business, as well as competitor business models. * Courageous and persuasive, combining strategic thinking and analytical ability to provide insight and drive decision-making. * Both results oriented and a team player, able to pivot between coaching and a hands-on management when necessary. Fosters a culture of innovation, transparency and accountability. * Able to bring new thinking and ways of working to the function, including an emphasis on continuous improvement. Key Responsibilities * Acts as a thought partner to the CFO, Executive Committee and the SVP, providing valuable strategic and financial analysis and insights. * Leads the company's annual long-range planning and budgeting processes, as well as quarterly and monthly executive-level management reporting processes. * Responsible for the timely, accurate, and insightful financial reporting and analysis of financial information to key stakeholders. Influences senior leadership on decisions utilizing financial insights and modeling. * Supports investor relations, treasury and other functions with modeling and analysis that incorporates company and external data. * Drives the adoption of common processes and standards across the company and in partnership with internal stakeholders. Identifies ways to improve the efficiency and effectiveness of companywide management reporting and forecasting. * Establishes best practices for the corporate finance function globally, including developing metrics to identify trends and measure financial performance * Works closely and communicates effectively with corporate partners in Investor Relations, Accounting, Tax, Treasury, and IT to ensure that corporate information and support needs are consistently met. #LI-BP1 Qualification: * Over 15 years of progressive, relevant financial leadership experience. BS Degree in Finance or Accounting, Masters preferred. Biotechnology/Pharmaceutical industry experience preferred. * Strong knowledge of US accounting regulations and company accounting policies and practices, and unquestioned integrity in the application of such standards. * Finance Process Excellence or Six-Sigma experience a plus. * Strong business acumen and judgment, and current knowledge of the company's markets/products and industry trends. Able to think strategically about business issues.
Vertex Boston, MA, USA
Aug 23, 2019
Full time
Job Description: Vertex Pharmaceuticals is looking for a Senior Manager, Quality Oversight to join our quality assurance team as we continue to advance proactive quality oversight of our clinical programs.This individual will be responsible for GCP/quality activities related to oversight and management of clinical trial execution, including development and execution of study level audit plans, monitoring/trending of quality and compliance metrics, deviation/CAPA management and inspection readiness.Experience with key performance indicators, metrics analysis, and monitoring/trending of quality and compliance metrics is advantageous.Vertex is an exciting, fast paced dynamic environment with a strong company culture focused on patients with unmet medical needs. The ideal candidate is someone who is not afraid to dive in and help develop this expanding team. Position may require up to 10% national/international travel. Key Responsibilities: * Execution and/or oversight of quality monitoring and assurance of clinical trial execution for assigned programs * Execution and/or oversight of Clinical Investigator audits, Documentation Audits and other study-specific or process audits * Engages with study teams and functions for proactive inspection readiness across assigned programs/areas * Analyzing, reporting and communication of metrics along with proposals for process improvements * Responsible for triaging, reviewing and approving Quality Issues and CAPA * Provides regulatory compliance support & guidance to cross functional clinical study teams * May serve as GCP Quality Management System representative * Participates in collaborative review of impacted SOP/WI * Reviews and analyzes key Performance Indicator data and trends * Analyzes risk and proposes remedial, corrective and /or preventive actions * May participate on process improvement initiatives * Provides support for Health Authority Inspections (preparation, support and follow-up activities) * Develops, maintains and ensures execution of strategic protocol specific audit plans and audit closure/summary reports for assigned people/programs * Monitors and trends events related to their process and identifies/proposes Corrective actions to address * Identifies risks/communicates gaps to Quality System Owner * Identifies and generates process related metrics- monitors for efficiency * Leads/coordinates internal quality improvement initiatives as appropriate Qualification: * M.S. (or equivalent degree) and 5 years of relevant work experience, or B.S. in a scientific or allied health field (or equivalent degree) and 8 years of relevant work experience, or relevant comparable background * In-depth knowledge of: * Auditing-language/roles/skillset - Interviewing, Deduction and Investigation skills with subject matter expertise on Clinical Investigator site and GCP document audits with ability to train others * Clinical Documentation (e.g. Investigator's Brochures, Clinical Study Reports, eCTD Module 2 documents for regulatory submissions, etc.) * ICHE6 (R2), 21 CFR Part 50, 54, 56, 312, 314, and familiarity with 21 CFR Part 11 and international equivalents, best practices, and industry standards * Event Management process and requirements, including investigation, root cause analysis, CAPA plan development and effectiveness checks * Change Management principles and process * Communication, Influencing, Presentation and Facilitation skills at all organizational levels PREFERRED QUALIFICATIONS: * Proven experience with all phases of clinical trial execution Phase I - IV trials * Previous experience with validation and change control preferred * Previous participation on material review and product complaint boards (or equivalent) preferred * Quality Management Systems within GCP discipline * Proven experience with quality assurance oversight and metrics management/monitoring in support of proactive quality risk management * Ability to provide GCP compliance interpretation, consultation, training and support to study execution team * Ability to understand and translate customer needs for innovative and creative approaches to quality management #LI-KF1
Vertex Boston, MA, USA
Aug 23, 2019
Full time
Job Description: Vertex is actively seeking a Senior Accountant/Analyst in the Supply Chain Controllership/Finance group to perform product costing and inventory accounting for the Company's existing products as well as future products sold in the U.S. and internationally. The Senior Accountant/Analyst concentrates on accounting for inventory related activities as well as analysis and forecasting of inventory standard costs, variances, reserves and cost of goods. The Senior Accountant/Analyst partners with our Supply Chain Management team and other stakeholders throughout the company. This position provides exposure to key accounting and financial reporting areas, offering development opportunities that can lead to advanced roles within the Finance organization or within other departments. Key Responsibilities: * Supports accounting for pharmaceutical products as relates to inventory and cost of goods * Collaborates across Supply Chain and Finance to monitor inventory during the production and delivery cycle * Prepares journal entries to support month end financial close deliverables * Reconciles and analyzes key balance sheet and income statement accounts * Plans, collects, and analyzes data to drive the annual inventory standard cost and revaluation processes * Performs cost variance and inventory reserves analysis and reporting * Supports quarterly forecast to actual reporting * Provides data for external auditors during quarterly and year end audits * Ensures SOX Compliance for responsible area, including implementing improvements to improve the efficiency of current controls * Conducts physical inventory audits, as required #LI-SO1 Qualification: * Bachelor's degree in Accounting or Finance * 3+ years of experience in a Corporate Finance/Accounting Department or Public Accounting Firm Preferred Qualifications: * Experience working in a manufacturing environment, Biotech/Pharma preferred * Experience with Oracle EBS, or similar ERP system, a plus * Strong/Advanced Excel skills * Strong communication and organizational skills * Demonstrated experience in Cost Accounting including working with manufacturing personnel on development and analysis of standard costs * Self-motivated individual with strong problem solving and analytical skills * Sound understanding of accounting principles * Proven ability to multi-task and work independently in a challenging fast paced environment * "Go getter" attitude with drive to learn and advance * Can prepare meaningful and accurate reports/analysis with high degree of accuracy * Ability to work independently with strong attention to accuracy and detail
Vertex Boston, MA, USA
Aug 23, 2019
Full time
Job Description: This individual will be responsible for the Employee Relations function across approximately 2,900 employees in our biotech organization. This individual will act in guidance with the Human Resource Business Partners, Business Managers and Senior Management on managing overall employment risk and Employee Relations resolutions. You will be responsible for establishing formal Employee Relations practices where applicable and will provide over site to the broader global organization. This position requires deep Global Employee Relations expertise as this individual will be instrumental in developing the framework and operating principles of ER and to support the overall employee experience. Key Responsibilities * Design and implement an ER framework, including policies to drive continuously improving ER practices within the global organization * Develop, socialize and rollout ER processes, guidelines and practices. * Conduct investigations and address employee issues and complaints working in partnership with the HRBPs, Legal and Compliance to make recommendations on appropriate courses of action. * Assists in the preparation of comprehensive investigation reports which includes recommendations for complaint resolution. * Provides insight and interpretation to managers and employees regarding relevant employment principles, complex employee relations issues, performance management, workplace investigations and critical incident management. * Present investigation findings and trends at executive levels facilitating decisions where appropriate. * Manage and maintain ER procedures and practices to ensure compliance, enhance the employee experience, and promote our company values in partnership with Employee Services where appropriate. * Ensure ER cases are handled fairly and consistently in a timely fashion, and in line with company values and applicable laws. * Partner with HRBP's to create and implement change management strategies and communications in support of org design and changes as appropriate. * Maintain an accurate, organized and confidential case management system. * Analyze ER trends to develop solutions and strategies and make recommendations based on ER related data. * Designs and facilitates training and workshops on key HR policies and best practices. * Advises on business change including acquisitions, restructurings and reorganizations. * Manages all exit interviews and analyzes trends with recommended approaches to resolve areas of concern. Qualification: * 8+ years of relevant experience in the Employee Relations field and a BS or BA degree. * Experience in the biopharmaceutical industry desired. * Excellent verbal and written communication and presentation skills. * Broad knowledge of HR principles, practices, and procedures in North America and globally. * Requires a depth of working knowledge and understanding of Human Resources legislation/employment law, principles, policies, and procedures. * Ability to exercise good judgment and provide strategic advice. * Must have demonstrable experience in changing work environments and the effects associated in the HR area. * Ability to effectively interact with employees at all levels of the Company. * Effective customer service skills. * Excellent teamwork and interpersonal communication skills are required. * Must possess solid influencing skills. * Work is performed without appreciable direction. Exercises latitude in determining objectives and approaches to assignment. * Ability to bring insight into the team/business in a multi-cultural and multi-location environment. * Ability to manage a high volume of work.
Vertex Boston, MA, USA
Aug 23, 2019
Full time
Job Description: Co-Op, Human Resources The Vertex Summer Internship Program offers students the opportunity to learn about the pharmaceutical industry from a hands-on perspective. You will be working closely with and learning from some of the brightest people in the industry. When you join our internship program you should not be surprised to see that our environment is one that is innovative and team oriented, where collaboration is not just a word, and "we are fearless" is in everything we do. Students can expect to be challenged by their summer project plan, connect with other interns, and feel valued by the Vertex community. Not only will interns learn about their day-to-day tasks through their specific work assignments, but they will interact and have exposure to our organizational leaders and their teams through a series of Professional Development Workshops. Be FEARLESS... Join us and help kick start the path to your career! This Co-Op runs from July 2019 until December 2019. Job Description Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases. This role will provide assistance & partner closely with GMDA (Global Medical Development Association) Human Resource Business Partner's (HRBP) team. Key Responsibilities This role will support GMDA HRBP's including but not be limited to: * Managing Onboarding & Off boarding related tasks. Coordinating with new hires managers on the questions, updates etc. * Conducting exit interviews, for below director level employees & keeping a record in workday * Assisting with day to day employee queries and solving issues through coordination with HR Ops & other COE functions. Providing transition assistance to HRBP's for My Vertex requests * Creating a cadence of Reporting Trends from Vizier for Functional Talent Plans, People Reviews etc. * Consolidating slides for People Reviews. Assisting with framework to track implementation for action plans of each Hi-Po talent. Addressing day to day queries on IDP, training programs. Coordinating with Talent Management team for the requests. * Workforce planning support for the business. Reviewing formats, aligning with the business & follow up to get timely input * Assisting with Career Development Week, to complete IDP's & assist as required for business critical priorities * Assist HRBP's during year-end and mid-year process, as required * Enabling data gathering from Visier, tableau etc. for creating the functional plans and building trends for each function. * Under supervisory guidance, handle confidential and sensitive employee information and assist in ER issues, as required * Assist HRBP's during business off sites, team building & other sessions such as NLA's. Qualification: * Graduate/Undergraduate with basic knowledge of Biotech industry & Human resources * Proficiency in Microsoft Word and Excel * At least 1+ years of working experience in any role/capacity * Ability to handle confidential employee information and to handle sensitive employee-related issues * Exceptional organizational and communication skills * Ability to operate in a fast-pace, changing environment * Ability to work with employees at all levels in the organization and across all functions Preferred Qualifications * Experienced in addressing complex issues through data analytics * Collaborative & flexible problem solving approach * Proven ability to work on presentations, excel & Workday * Positive, Open & Collaborative approach * Drive for results with focus on quality * Capability to partner, adapt & take action to solve issues * Demonstration of Vertex's Core Values: Fearless pursuit of excellence, innovation is our lifeblood and "WE" wins * Minimum grade point average of 3.0 is preferred
Vertex Boston, MA, USA
Aug 23, 2019
Full time
Job Description: The Director of Benefits and Mobility will oversee the operations of our North American Benefits and Mobility programs and provide global strategic direction for global benefit and mobility programs to ensure overall global alignment. He or she will ensure our benefits programs support company goals and objectives and support our culture and values. The position works closely with the VP HR Total Rewards on strategy and design. Key Responsibilities * Responsible for developing and executing the global benefits and mobility strategies as well as providing the technical analysis, administrative oversight and support. * Design and implement benefit programs, processes and practices that are responsive to the company's changing business needs and requirements/regulations. * Manage our 401(k) Plan; work with our retirement plan advisor and plan administrator, including leading the 401(k) Committee. * Serve as primary contact and partner with Global Benefits Brokers/Consultants and vendor partners to ensure benefits are designed competitively and delivered efficiently and effectively. * Ensure compliance with all regulatory agency requirements including but not limited to the IRS, DOL and ERISA regulations. * Oversee the annual open enrollment process including communications, coordination with outside vendors, HR system changes, and any other oversight as needed. * Oversee US relocation and Ex-pat programs including policy design and on-going enhancements. * Proactively monitor and assess current benefit programs, market trends, legislative, tax and social changes that impact current programs and report necessary or suggested changes to management. * Develop and implement an innovative comprehensive and engaging wellbeing strategy; oversee communication plan and coordination of wellness activities and events. * Manage effective communication of benefit strategies and programs to drive employee engagement and usage of health and welfare programs. * Drive operational excellence ensuring processes are documented, efficient and in compliance with applicable regulations. #LI-RS1 Qualification: * Bachelor's degree and 15 years of experience in benefits administration, including plan design, analytics and vendor management * Significant knowledge of employee benefits programs and human resources * People management experience Preferred Qualifications * Excellent human relations and communications skills (both verbal and written) * Strong analytical skills, attention to detail and organizational skills * Ability to work independently * Computer proficiency: strong computer proficiency, including experience with Human Resource Information Management Systems, preferably Workday * Ability to deal with protected sensitive information and handle with strict confidentiality * Strategic skills (learning on the fly, strategic agility, dealing with ambiguity) * High-level compensation experience
Vertex Boston, MA, USA
Aug 23, 2019
Full time
Job Description: The Sr. Quality Specialist is recognized as an expert internally in the principles and application of quality assurance and compliance. The Sr. Quality Specialist coordinates GMP activities in support of clinical and commercial Drug Product disposition. The Sr. Quality Specialist demonstrates high level of involvement in continuous improvement of quality assurance philosophy and practices ensuring alignment with all regulatory requirements. KEY RESPONSIBILITIES: * As part of the Quality Operations and Compliance group primarily responsible with providing quality oversight and support to operations at the Vertex Drug Product Facility (VMC) in the following key areas/activities; support of manufacturing operations across all phases of development and commercial, support of analytical laboratory operations, and materials management. Product Release - Internal Manufacturing * Responsible for commercial and clinical batch disposition. Review batch data, including batch records, deviations, in-process data, EM data, QC release testing and other quality systems as applicable to determine acceptability of product disposition. * Responsible for approval of clinical and commercial lot COAs, generating BSE/TSE statement and product labelling * Responsible for archival of batch records and other supporting documents in QDoCCs. * Responsible for generating performance metrics, trends Compliance Oversight of Internal Operations - QA Operations and Compliance * Provide production floor support and provide guidance for GMP product quality and compliance for product release, including resolution of product quality investigations and quality issues of a significant nature, and provides direction for product disposition decisions including shipment. * Review and approval of Manufacturing documents e.g. MCR, MBR, Recipe, Engineering Parameters etc. * Responsible for raw material release, area clearance, line clearance and equipment release. * May be required to assist the QA Engineering group with activities associated with equipment, instrument, utilities, and/or facility qualification activities including change control, and support of site programs. Compliance Oversight of Quality Systems * Provide QA support of development and commercial change controls, GMP investigations, associated CAPAs and Effectiveness Checks. Lead the investigation/CAPA triage meetings (as necessary) and collaborate with customer groups to ensure quality systems are monitored and established metrics are met. * Responsible for generating performance metrics, trends; including site metrics for investigation/CAPA, etc. * Lead compliance walkthroughs of the site and help drive the closure of any observations. Quality Process and Ownership of Equipment, Area, and Incoming Material Release * Responsible for identifying risks and communicating any gaps for quality processes optimization for area/equipment release, material disposition, quality systems etc. * Participate in continuous improvements of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources. Establishing or Tech Transfer of Products * Responsible for supporting new product introduction into the Drug Product Facility by review and approval of new MBRs and material master files. Audit / Inspection Support * Participate in inspection readiness activities and provide support during regulatory site inspections (as necessary). Deployment of QMS and Establishment of Compliance Expectations * Participate in process improvement initiatives (as necessary), performing gap analysis and risk communication. * Act as a trusted advisor to the site by providing compliance guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of quality issue in a timely manner. Qualification: * Master's degree and 0 - 3 years of relevant work experience, or Bachelor's degree in a scientific or allied health field and 5 - 8 years of relevant work experience, or relevant comparable background * Demonstrated success independently leading cross-functional teams * Experience providing QA support and oversight of GMP manufacturing operation including batch release * Experience with drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge of the following in a pharmaceutical setting: o cGMP's and associated CMC regulatory considerations * Experience with continuous manufacturing a plus * Experience with equipment, facilities and utility system qualifications activities in a cGMP setting * Experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA * Experience with network based applications such as Oracle and TrackWise preferred.
Vertex Boston, MA, USA
Aug 23, 2019
Full time
Job Description: Vertex Pharmaceuticals has an exciting opportunity for a Temporary Research Scientist in the area of medicinal chemistry. Job responsibilities include preparation of both single and focused sets of small organic molecules, development of optimized synthetic methods as needed, creating and interpreting project relevant SAR, and problem solving. Candidates must demonstrate an expert understanding of organic reaction mechanism, be up to date with contemporary synthetic methods, and be able to balance rational concepts with creativity which would include development of new synthetic methodology as needed. The successful candidate will be able to work independently, be able to multi-task, be able to work collaboratively in teams, and be adaptable to changing needs. A strong desire to grow as a medicinal chemist while maintaining a passion for organic chemistry and the courage to challenge conventional wisdom are essential. Key Responsibilities: * Primarily responsible for executing organic synthesis in a timely, efficient, and independent manner * Create and interpret SAR with a clear understanding of the biological data * Organize efforts to stay consistent with project priorities * Clearly and effectively communicate ideas and results (both verbally and in writing) to a broad range of audiences Qualification: * Master's degree in organic synthesis * 7+ years of relevant employment experience * Demonstrated effective communication skills, both verbal and written * Ability to navigate and be successful in a fast-paced, highly-matrixed work environment Preferred Qualifications * Ph.D. in organic synthesis * 5+ years of productive, relevant post-doctoral and employment experience * A desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society
Vertex Boston, MA, USA
Aug 23, 2019
Full time
Job Description: Vertex Pharmaceuticals is seeking a Senior Director, Global Marketing for the Pain Program. This individual will be the global brand lead for the Pain Program responsible for the overall launch strategy, collaboration with Research, Clinical Development and Commercial colleagues to ensure commercial success of the program. This individual will possess a desire for team success in a highly innovative company aimed at redefining health and transforming lives with new medicines. The position reports to the Vice President of Global Marketing. Key Responsibilities: * Partner with Research, Development & Commercial colleagues to create and communicate the vision and launch strategy to optimize the success of the Pain Program worldwide * Provide commercial input into the Clinical Development plan and Regulatory strategy to optimize launch success * Co-lead the Pain Late Stage Project Team with Clinical Development across multiple functions to ensure successful execution of the Pain program for launch as well as creation of a clear Life Cycle strategies. * Lead the Global Commercial Team to create & execute the Global Commercialization Strategy * Ensure global launch readiness through preparation and support of regions and countries * Ensure integration and geographic alignment of commercial strategies * Partner with Research, Development & Commercial colleagues to create and communicate the vision, strategy, and key global initiatives that will prepare pain assets for launch and lifetime value maximization * Lead the Global Commercial Brand. * Gather competitive insights in pain and assess impact on Vertex's competitive position * Develop global sales forecasts for Pain franchise within the long-range plan, identify key levers in the forecast and create strategies and global tactics to drive success. * Partner with the Global Market Access & Value team on the development of value propositions for Pain assets across all age ranges. #LI-SO1 Qualification: * Bachelor's degree * 10-15+ years of experience in the pharmaceutical, biopharmaceutical or consulting arena, including some combination of marketing, sales, or market research and new product planning. * Global or country experience an advantage Preferred Qualifications: * An entrepreneurial spirit and ability to develop creative solutions to complex problems. * Excellent communication skills coupled with the ability to clearly distill commercial strategies into understandable, and actionable recommendations. * Ability to drive disruptive innovation in a category. * Thought leadership and team leadership skills. * Results oriented and strong analytical skills * Ability to manage complexity and ambiguity in a highly matrixed environment * Demonstrated ability to manage initiatives that require collaboration across multiple functional areas. * An MBA or advanced science/medical degree * Launch experience in the Pain market in the US or EU is ideal * Global experience working across regions and countries a plus. * A strong understanding of the legal and regulatory environment * Display solid ethics and demonstrated integrity on the job
Vertex Boston, MA, USA
Aug 23, 2019
Full time
Job Description: The Senior Director/Head of Regulatory Toxicology and will report directly to the Head of Preclinical Safety Assessment. This dynamic individual will be responsible for the management of the Regulatory Toxicology Group and will have oversight of all regulated safety programs in addition to the expectation of serving at the individual project team level to support progression of novel therapeutic agents through the drug development process. A strong background in Regulatory Toxicology including extensive knowledge and understanding of Good Laboratory Practices (GLPs), ICH Guidelines, experience interacting with Regulatory Authorities, and authorship of Regulatory Correspondences and Dossiers is required. Key Responsibilities: * Management and oversight of up to 4 intermediate to senior level regulatory toxicologists * Oversight of design, conduct, interpretation, and reporting of all regulatory toxicity studies including resulting risk assessments * Plan, design, and effectively manage/conduct and oversee designated toxicology programs necessary to support the selection and timely development of potential drug candidates through close interactions with discovery toxicologists, and affiliated preclinical and clinical development functions, as necessary * Coordinate toxicological/preclinical safety evaluations of development candidates locally and internationally with external contract laboratories, consultants, and development partners * Responsible for lead authorship of pertinent sections of internal and external regulatory documents (IBs, CTXs, INDs, NDAs, RMPs, Expert Reports, etc.) * Address and resolve toxicological issues arising in drug development programs, and adequately assess the relevance of any toxicological findings to human safety. * Build strong scientific collaborations with external groups within both the academic and industrial sectors with the intent of enhancing Vertex's Preclinical Safety Assessment capabilities. #LI-BS1 Qualification: * Ph.D. in Toxicology or relevant field; DABT Board certification preferred. * A minimum of 12 years of experience in the Pharmaceutical Industry with a proven track record of conduct of drug safety assessment studies, demonstrated ability to manage personnel and multiple scientific projects, and make sound scientific interpretations and risk assessments * Proficient knowledge of general toxicology is required, demonstrated expertise in inhalation toxicology an added bonus * In depth understanding and working knowledge of regulatory toxicology, GLPs, and US and International Regulatory Guidelines * Strong problem solver who is highly organized with the ability to thrive and to lead in an environment with rapidly changing priorities
Vertex Boston, MA, USA
Aug 23, 2019
Full time
Job Description: Vertex Pharmaceuticals Inc. is looking to hire a Director level Human Resources Business Partner to join the HR team in Boston, MA. Today, Vertex employs 2,600 people across three R&D sites (Boston, Oxford and San Diego) with commercial offices in the United States, Canada, United Kingdom, Europe, and Australia. Approximately 2/3 of all Vertex employees are involved in R&D with a significant investment of revenue into Research on annual basis. As we build to the future, we seek an experienced Human Resources leader to partner with business leaders, to lead the build of a new (our fourth) R&D site including development and delivery of hiring plans, onboarding and assimilation, and merger & acquisition/integration support. This site will be focused on the forefront of scientific innovation in the area of Genetic Therapeutics based in the Boston area. The HR Business Partner will provide proactive HR leadership and consultation to client groups within this fourth Research Site. The HRBP will partner with leaders on business strategy and develop and maintain an understanding of the operating environment to proactively deliver applicable solutions. This role is responsible for driving talent management, helping to architect and manage organizational change as well as the delivery of HR programs and services such as employee relations, talent/career development, manager coaching and consultation, talent acquisition of key positions, compensation processes and performance management that create a leading edge culture and climate aligned with the strategic direction of broader Vertex organization. This position reports to the Lead HRBP for Research and is an active participant on the Research HRBP LT. Key Responsibilities: * Responsible for creating the Strategic Workforce Plan for the development and launch of the new site including the development and execution of the human capital build plan with a focus on quality and speed to hire. * Responsible for providing HR leadership and guidance to assigned client groups, along with consultation and delivery of HR programs and services to achieve business plans * As part of Research HRBP Leadership Team, provide input, insight and strategic direction to the broader Research Strategic Workforce Plan. * Define, build and implement value-added HR strategies and solutions that create culture of development, growth and scientific innovation. * Act as an internal consultant to leaders, managers, and employees providing coaching and advice on a range of organizational and change issues * Ensure the business attracts, develops, and retains high quality talent at all levels to support the growth objectives, opportunities, and strategies of the business * Organization and HR Planning - including identifying the people and organizational implications of the business strategy, the identification and development of key talent, and succession planning * Build strong partnerships with the HR COE's such as compensation, benefits, talent acquisition, HREmployee Services and Operations and leadership & employee development to roll out corporate wide programs and to address client needs and business priorities * Work with clients to implement and manage key HR processes, such as the year-end performance management process (performance assessment, calibration, and compensation planning) * Provide employee relations expertise to client groups ensuring compliance to company practices; state and federal employment law. * Work with managers and employees in identifying and addressing performance related issues * Partner with Talent Acquistion and the business to develop sourcing strategies that address short and mid-term capability needs. * Identify data analytics to identify trends and proactively create solutions to address trends #LI-RS1 Qualification: * Bachelor's Degree - Human Resources preferred * 10+ years of progressive human resources experience, including deploying HR strategies to meet business objectives; experience in the areas of talent management, organizational effectiveness, management development, employee relations and strategic process management * Merger and Acquisition/Integration experience strongly preferred * Pharmaceutical/biotechnology experience required, with experience supporting R&D client groups strongly preferred * Experience in building out a site or function in high growth mode * Strong communication and collaboration skills with the ability to think globally and act locally required
Vertex Boston, MA, USA
Aug 23, 2019
Full time
Job Description: We are seeking a seasoned life sciences attorney to lead our small but mighty FDA Regulatory Law group and to join our whip-smart and highly respected Legal and Compliance Department at the company's world headquarters in Boston, MA. The Department is committed to a trusting and collaborative culture where we value growth and development. We engage proactively with our business colleagues to truly understand them and to deliver results for our company and for patients. If you thrive in a fast-paced, hands-on, and team-oriented environment where you can have a big impact on the organization, we'd love to talk to you! The individual in this position will be the point person for providing strategic and solutions-oriented legal advice to a broad spectrum of internal clients, including senior leadership, from the following functions: Clinical Development, Real World Evidence, Clinical Trial Transparency, Translational Medicine, Publications, Managed Access, Quality, Regulatory Strategy, Regulatory Policy, Safety, and Global Marketing. This role will be highly visible and will have the opportunity to directly contribute to Vertex's success, and thus candidates must display a high level of executive presence and leadership competencies. The position has one direct report (an attorney) as well as responsibility for managing a budget. This position will report to the Vice President of Commercial and Regulatory Legal. Key Responsibilities * Advising business leaders on strategies and tactics in a way that advances the company's business while addressing legal risks and protecting the company's integrity and reputation. * Providing practical and timely advice on various corporate initiatives and activities, such as clinical development of investigational compounds (including design of studies to support regulatory approval), regulatory strategy for new products and line extensions, Hatch Waxman issues and life cycle management, design and use of real-world studies to support regulatory submissions, investigator meetings, expanded access programs, publication issues, FDA inspections, GxP compliance, recalls, clinical trial reporting, EMA Policy 70, and clinical trial data sharing. * Helping to draft responses to proposed laws and regulations, FDA guidance documents, and industry group policy positions. * Providing regulatory law support for transactions, including conducting regulatory due diligence, negotiating key regulatory terms, and supporting post-transaction integration activities. * Providing regulatory law support to brand attorneys on advertising and promotion issues. * Keeping abreast of regulatory developments affecting clients (e.g., cell and gene therapies, mobile medical applications, track and trace) and anticipating potential obstacles in obtaining desired regulatory outcomes. * Providing oversight and guidance on matters handled by direct report. * Participating in various Legal & Compliance Department projects and initiatives (e.g., Culture Committee, Pro Bono & Community Engagement Committee, Talent & Development Committee, Diversity Committee, offsite planning, strategic planning). #LI-RS1 Qualification: * JD from an ABA accredited law school and member of a state bar. * Minimum of 12 years' experience providing FDA regulatory advice to pharmaceutical, biotechnology, or medical device companies, whether in-house or at a law firm with a nationally recognized FDA life sciences practice * Specific expertise required in statutes, regulations and guidance concerning: GxP, drug development, regulatory submission standards, expedited programs for serious conditions, promotion and scientific exchange, Hatch-Waxman, Orphan Drug Act, DQSA, clinicaltrials.gov reporting, and fraud and abuse. * Solid working knowledge of other laws, regulations, and industry standards that affect the development and commercialization of pharmaceutical and biotechnology products, including FCPA, competition law; OIG guidelines and opinions; Sunshine Act/transparency laws; privacy laws, product liability, and industry standards (e.g., PhRMA guidelines, ICMJE and GPP standards, ACCME guidelines). Skills/Abilities * Consummate team player with excellent judgment and interpersonal skills. * Ability to constructively counsel and influence clients in making the right decisions, and to make tough calls. * Capacity to simultaneously handle a variety of complex legal matters with minimal guidance * Demonstrable experience taking ownership of issues and providing timely, actionable advice. * Exceptional written, oral and presentation skills.
Vertex Boston, MA, USA
Aug 23, 2019
Full time
Job Description: Temporary Contract, 6 Months This role involves managing materials in support of continuous drug product manufacturing, clinical manufacturing, kilo lab, and analytical laboratory operations that span development and commercial environments. The Materials Management Associate will partner with drug production teams in all phases of development from clinical drug product through commercialization. Key activities will include managing the receipt, sampling, disposal, and storage GMP Materials. Material management staff will be skilled to work within the Oracle Product Management system (OPM) based materials management system, managing all material transactions. Key Responsibilities: * Maintain the inventory management and retain systems accurately * Receive and inspect GMP materials in accordance to SOPs. * Sample incoming materials in a timely fashion and in accordance with departmental sampling plans * Review customer requests for material delivery. Pick and deliver materials to the Drug Product Facility. Transfer of materials to and from the warehouse using an effective workflow * Store materials in appropriate GMP conditions * Always handle materials safely and follow cGMP's, safety requirements and departmental policies and procedures * Manage inventory with Forklift Technical and Communicative Skills: * Demonstrates astute understanding of how to deploy his/her own talents effectively * Has knowledge of relevant science beyond own department Qualification: * Experience working in a warehouse environment managing inventory, including use of forklift. * Degree in relevant field. * The ability to work in a fast pace environment. Can-do attitude is a plus. * Excellent documentation skills are required * Experience operating in a clinical and commercial GMP environment is preferred.
Vertex Boston, MA, USA
Aug 23, 2019
Full time
Job Description: Are you passionate about using technology to drive the discovery, development and commercialization of break through medicines? Do you have experience in developing leading technology solutions supporting drug development? Are you looking for an opportunity to utilize your technical and leadership talent to drive technology architecture and implementation in a fast pace innovative environment? You might be the person we are looking for. As we are embarking into the transformation of our technology landscape to support drug development from Biomarkers to Medical Affairs, we need to design and establish technology solutions that will support our organizational growth globally. The solutions architect for GMDA IT will enable our roadmap by conceptualizing and assembling technology solutions aligned with our enterprise reference architecture. With your deep understanding of business goals, processes and modern architecture you will work on a variety of projects as the technical authority. Working closely with business partners across Medicines Development, IT functional leaders and an extensive network of technology solutions providers you will explore, define and assemble impactful, scalable and cost-effective technology solutions to support all aspect of medicine development and Medical Affairs. Responsibilities * Serve as the technical architect for the design and implementation of the GMDA roadmap in alignment with our enterprise architecture * Provide technology oversight and architectural review for all GMDA IT projects * Research and evaluate emerging technology for drug development * Assist GMDA business partners in the evaluation and selection of novel technology solutions supporting the drug development process #LI-RS1 Qualification: * Technical literacy: as a technologist you "know your craft", you are fluent with the digital world and can help our business team realize the full potential of modern technology. You have firsthand knowledge of cloud technology, securing data into the cloud, modern architecture patterns (serveless, APIs, data lakes) and can drive architecture definition and implementation. You are very familiar with modern data reference architecture. * Business knowledge: You have a demonstrated knowledge of business processes for drug development, have worked in a pharma environment extensively, and subscribe to our mission of discovering transformative medicines to help people with serious diseases * Collaboration: You proactively engage with the GMDA teams, GIS peers, Data Science and Strategy leaders as well as external partners to solve complex problems that require advanced technology capabilities. You are adept at introducing new technologies efficiently, surfacing and managing competing priorities, and developing optimal technology solutions that serve the greater team. * Ability to deliver: simply put you get things done. You do not hesitate to dive in and work alongside your team to drive projects to success. You can effectively manage a distributed or virtual team, juggle multiple efforts simultaneously, and deliver integrated solutions which serve multiple GMDA customers. * MS or PhD in Science or Engineering, with a concentration on data subjects (stats, data science) preferred * 10+ years of overall work experience and definite experience in drug development, translational medicine and data science. * Proven knowledge of AWS data and analytics stack, interoperability standards (CDISC, FHIR,OMOP etc.), and standard analytics platforms: R, Python, SAS * Demonstrated application of emerging technologies (augmented analytics, RPA, AI/ML, etc.) in a regulated environment * Bring an entrepreneurial and ethical mindset, openness, transparency, and collegiality to your work * Able to thrive in a fast-paced environment with uncertainty.
Vertex Boston, MA, USA
Aug 23, 2019
Full time
Job Description: This position will drive value across all functions and geographies and will be a force multiplier for Vertex's growth. We are seeking an individual who has developed and executed a successful global Learning & Development strategy that directly supports and is aligned with the business strategy; leveraging the latest technologies and learning best practices. The position reports directly to the VP, Talent Management and the role is based in the Boston Vertex headquarters. Key responsibilities: * Own the global Learning & Development vision, mission, strategy, business plan, goals and resulting execution to implement dynamic learning systems that are integral to the success of the organization * Collaborate with Vertex managers, executives and work closely with the functional learning leads globally to achieve desired business results and to target and implement program improvements * Align and develop resources to deliver on the strategy (subject matter experts, L&D team members, vendors, program budgets, technologies, etc.) * Develop the infrastructure for all learning and development programs by establishing standardized methods and procedures for delivery, evaluation, measurement and reporting * Design and implement learning and development programs, consistent with best practice and innovative approaches, to address new hire on-boarding, new role transitions and proficiency building * Demonstrate expertise in designing and/or procuring global development programs, processes and tools for the leadership population * Develop assessments that measure learner outcomes including productivity * Develop blended and scalable training solutions, evaluating both face-to-face, virtual, and digital solutions, for delivery to a large audience throughout the globe, making learning an unforgettable experience * Collect and analyze data to continuously improve and expand programming across the functions supported as well as to address development needs for high-volume roles #LI-RS1 Qualification: * Bachelor's degree in business or related field with Master degree preferred * At least 15+ years professional experience in management of global, corporate learning programs * Ability to apply sound learning principles, agile methods, learning technology and program management skills together in the design, development and maintenance of learning programs * Global program administration and coordination, including classroom facilitation experience * Experience working with a variety of global external suppliers/vendors for training * Instructional design skills; familiarity with adult learning principles * Experience working with learning support technology, such as eLearning software, virtual classroom technology, 3rd party learning applications, micro-learning etc. * Experience building a global learning organization infrastructure * Experience designing and delivering global leadership development programs, focused on building core people leadership capabilities * Experience building career ladders/paths and the tools and resources need to support career development * Demonstrated business acumen * Strong project management and organization skills * Systems thinking; able to recognize patterns and trends in data, content and customer needs which will drive program design and delivery * Influencing and relationship building; builds a network of experts and resources to support programs * Creative problem solver; naturally curious and can quickly research issues * Can successfully deal with a fast-paced environment with competing priorities across multiple stakeholders. * Strategic thinker that gets things done * Effective communicator and influencer with outstanding writing, editing and verbal communication skills * Ability to communicate effectively with technical and non-technical team members * Excellent presentation skills
Vertex Boston, MA, USA
Aug 23, 2019
Full time
Job Description: Temporary Contract, 6 Months The responsibilities of this position may include, but are not limited to, the following: * Assigns training to users in electronic learning management system (ELMS) per direction from Hiring Managers * conducts follow up with risk owners to maintain risk logs and ensures the system information (e.g., criticality, GxP type, business owner) for each GxP system is accurate in the Change Management * Coordinates contracts and agreements; assists with execution of Purchase Orders (PO)/Requisitions, and conducts follow-up on approvals; distribution of PO; troubleshoots vendor payment issues; Conducts follow-up on Confidentiality and Disclosure Agreements * Coordinates logistics for audit and inspections * Coordinates scheduling for Periodic Reviews * Develops audit response document(s) from final audit reports * Distributes/-osts SOPs to external parties per approved process * Facilitates SOPs through electronic document management system (EDMS) * Generates Metrics and Metrics reports * Maintains action logs, approved vendor list (AVL), templates and trackers * Performs Data Entry into GxP Regulated Systems as required * Manages events/CAPAs in electronic quality management system (EQMS), including data entry, tracking, and follow-ups with Owners to drive completion * Performs Archival of QA Records in EDMS and files documents to Sharepoint (e.g., audit records) and trial master file (e.g., audit certificates, plans, etc.) * Reviews travel & expense statements from auditors * Schedules and coordinates meetings, including audit meetings (e.g., pre audit, debrief, etc.) Qualification: * Bachelor's degree and 0 - 3 years of relevant work experience in the Biotech or Pharmaceutical industry, or relevant comparable background Preferred Qualifications * Adaptability/flexibility * Strong written and verbal communication skills * Attention to detail * Organizational/planning and coordination skills
Vertex Boston, MA, USA
Aug 23, 2019
Full time
Job Description: Vertex Pharmaceuticals is currently seeking a Senior Talent Acquisition Consultant to provide recruiting support to our Global Medicines Development and Affairs client groups as well as other groups to be assigned. This is an incredible opportunity for an experienced recruiter to join a phenomenal team and make an immediate impact. Key Responsibilities: * Create and execute a recruiting strategies, which result in top-tier, qualified talent pools of professionals to build strong recruitment pipelines * Become a credible, trusted talent advisor to the business * Develop and execute sourcing strategies, pre-screen candidates and deliver pre-qualified diverse candidates for hiring manager's evaluation * Ensure a positive client and candidate experience throughout the full recruitment life cycle. * Partner with hiring managers to identify roles of interview team, assign competencies/areas of focus using both technical and behavioral interviewing models * Effectively integrate diversity and veteran recruitment into the staffing process to ensure diverse candidate slates. * Grow existing network, foster new relationships and attend networking events to further identify talent for the organization * Partner with other functions to attract and hire talent that will help to sustain and contribute to the Vertex culture * Provide weekly and ad hoc updates to Talent Acquisition team, hiring managers and business partners as needed * Effectively manage the recruitment process by balancing budget, timelines and customer needs * Ability to select qualified vendors and maintain positive relationships * May contribute to projects as part of the long-term strategy of building a best-in-class talent acquisition organization * Other duties as assigned Qualification: * Bachelor's degree * 6+ years pharmaceutical or biotech recruiting experience * Experience working in a fast-paced, highly matrix organization * Proven track record of finding unique ways to source and attract qualified candidates * Superior selection skills and a high level of proficiency in assessing individuals * Proven ability cultivating successful relationships internally and externally * Results driven, ability to demonstrate/quantify success relative to established targets and metrics * Possess exceptional emotional intelligence and decision making skills * Strong listening, facilitation and communications skills * Strong organizational, multi-tasking and computer and web skills, along with the ability to handle sensitive and confidential situations/information * Ability to manage time efficiently and effectively and be proactive * Highly organized and attentive to detail Location: This role is based on site in our Boston, MA office
Vertex San Diego, CA, USA
Aug 23, 2019
Full time
Job Description: * One year contract position* Vertex Pharmaceuticals is currently building our HR function to continue our evolution of being a transformational partner in the exciting journey of impacting patient's lives with our innovative and life changing science. Currently, there is an opportunity for a strategic HR Business Partner at our San Diego Research site. You will focus on the strategic business challenges and partner with the leaders to provide targeted human capital insights and to act as advocates and champions of the values, culture, and overall HR Operating model. HRBPs work across the HR organization and in partnership with our Centers of Excellence to provide coordinated solutions to the needs of the business. Work in partnership with the HRBP Leads to help drive the HR strategy with a strong business perspective. * Actively advise and provide solutions related to workforce, talent and organizational matters to business leaders to achieve business plans. * Collaborate with HR Employee Services team to deploy services that are required to be executed at a local level. For example: * Payroll and Benefits * Local development and training * Onboarding * Performance and compensation reviews * Act as an internal consultant to leaders, managers, and employees providing coaching and advice on a range of organizational and change issues. * Ensure the business attracts, develops, and retains high quality talent at all levels to support the growth objectives, opportunities, and strategies of the business. * Organization and Strategic Workforce Planning - including identifying the people and organizational implications of the business strategy, the identification and development of key talent, and succession planning. * Build positive relationships with the HR specialist functions such as compensation, benefits, talent acquisition, employee services and leadership & employee development to roll out corporate-wide programs and ensure client needs are understood and met. * Work with clients to implement and lead key HR processes, such as the year-end performance management process (performance assessment, calibration, and compensation planning). * Work with managers and employees in identifying and addressing performance related issues. * Partner with Talent Acquisition and managers on sourcing strategies. Conduct interviews and recommend candidate selection for manager and senior level positions. * Identify key trends and collaborate with the HR team to provide recommendations and solutions. * Willingness to "roll up the sleeves" to get deep into details and day-to-day administration Qualification: * Bachelor's Degree preferably in Human Resources or related field of study * 7 or more years of human resources experience, including experience implementing HR strategies, experience in the areas of talent management, interpersonal effectiveness, management development, employee relations and strategic workforce planning. * Demonstrable track record of being able to assess business needs, develop solutions and implement with measured impact on the business. * Pharmaceutical/biotechnology experience required, with experience supporting Research, G&A client groups strongly preferred Core Competencies * Strong Business insight * Strong execution focus * Experience in leading change management initiatives * Positive relationship management, team-building, customer-focused orientation coupled with the ability to deliver results and meet or exceed agreed-upon objectives and timeframes * Ability to handle multiple priorities * Excellent communication and social skills, including strong presentation skills * Personal flexibility and a can-do attitude * Strong analytical and problem-solving experience, combined with business judgment and ability to present analysis in a clear and compelling manner
Vertex Boston, MA, USA
Aug 23, 2019
Full time
Job Description: The GxP Engineer is responsible to provide Engineering support through the GxP Facilities Operations and Engineering Department at the Vertex Manufacturing Center (VMC). The qualified candidate will report to the Manager, GxP Engineering or designee. The role will provide technical support, including project management, change control and commissioning and qualification for clinical and commercial OSD manufacturing equipment in the Drug Product Facility (DPF), the Kilo scale API manufacturing areas and GxP facility MEP systems in a manner compliant with regulatory expectations, company policy and current procedures. KEY RESPONSIBILITIES: * Self -perform and utilize other internal and external resources to execute small projects, implement appropriate levels change management for manufacturing equipment and other facility support systems including commissioning and qualification, implementation of other related initiatives as assigned. * Manage creation and revision of Commissioning and Qualification Protocols, Reports, and Engineering Documents including, but not limited to, IOV, drawings, user requirement specifications and SOP's. * Effectively work with cross functional stakeholders to achieve departmental goals and objectives * Supply GEP (Good Engineering Practice) expertise drawn from experience and/or supplemented by external resources to trouble shoots facility, utility and manufacturing equipment or system issues and recommends effective resolutions. * Balance degree of innovative exploration with pursuit of project objectives and coordinates implementation / integration of new capabilities as appropriate. Demonstrate planning and organizational skills, including complex project management. * Ability to lead by influence. * Foster change and innovation - Seeks solutions that strengthen quality, value, service and effectiveness * Demonstrate business acumen and business agility - Demonstrates functional/technical proficiency, engages in effective operational and strategic planning * Accountable for Results - Translates goals/objectives into actionable plans and results * Able to work on multiple projects and manage various priorities and timelines * Demonstrates proficiency in the following competencies: Responsive to change - Adapts (quickly) to changing circumstances Model collaboration and commitment - Focuses on team success before individual success Demonstrates operational excellence - Continually looks for new and better ways to get things done and shows functional/technical proficiency in work Demonstrates effective self-management - Seeks to understand and act upon improvement opportunities Ability to use Project Management tools and ability to review Engineering Document and Models (CAD, Revit etc.) Qualification: * B.A, B.S. in Engineering or related discipline with 3-5 years of relevant experience * Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI. * Knowledge of facility related engineering disciplines (MEP) in GMP manufacturing environment, preferably oral solid dosage or related experience. * Excellent verbal and written communication skills * Strong interpersonal skills, including the demonstrated ability to manage through influence.