AbbVie

  • South San Francisco (Pharmacyclics) 601 Gateway Blvd, Suite 100 South San Francisco, California 94080
  • https://www.abbvie.com
AbbVie Redwood City, CA, USA
Feb 23, 2020
Full time
Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products - Imbruvica®, Venclexta™, and Empliciti™ and a pipeline containing multiple promising new molecules that are being studied in nearly 200 clinical trials in 19 different types of cancer. AbbVie is expanding its oncology hub on the West Coast, with three sites in the San Francisco Bay Area (Redwood City, South San Francisco, and Sunnyvale) focused on the discovery and development of novel oncology therapies. More than 1,000 AbbVie scientists, clinicians, and product developers with strong entrepreneurial roots work across these three sites. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. AbbVie is also expanding their expertise through partnering with companies leading the way in emerging biologic technologies including oncolytic virus' and CAR-T cells. The Associate Director/Director, Regulatory Affairs will develop and implement global regulatory strategies to support the development of multiple oncology early development assets. This role provides leadership in the strategic guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables. This position is based at AbbVie in the Redwood City, CA location. Key Responsibilities Include: Develop and implement competitive and effective global regulatory strategies for various oncology products including clinical, nonclinical and CMC aspects and identify potential risks associated with proposed strategies Manage and participate in the creation, review, assembly and submission of regulatory documentation such as INDs and its international equivalents, expedited program designations, orphan drug applications, annual reporting, pediatric plans, and amendments related to clinical trials Coordinate and consult with subject matter experts on the content, review and publication and assembly of regulatory documentation Serve as primary Health Authority contact for assigned projects Provide advice and guidance to project teams on the interpretation and application of relevant regulatory requirements and review processes. Present global regulatory strategies and issues at team or governance meetings Collaborate with regional and country regulatory affiliates to support international development activities Coordinate and prepare for Health Authority meetings and associated briefing document preparation Attend relevant functional area and project team meetings, including nonclinical, clinical, and regulatory sub teams Position will be filled at a level commensurate with experience Bachelor degree in a life sciences, chemistry, or related discipline. Advanced degree preferred 8 to 12 years of experience in Regulatory Affairs (minimum 4 years within oncology) in the biotechnology or pharmaceutical industries, including an in-depth knowledge and understanding of the regulatory environment. International regulatory experience required Knowledge of current US and EU regulations for oncology drugs, including experience preparing, filing, and performing life-cycle management of applications and all supportive amendments, supplements, and annual reports to the United States Food and Drug Administration (US-FDA) in eCTD format Knowledge of oncology global clinical trial regulations, including experience with submission of Clinical Trial Applications (CTAs) to global regulatory agencies and management of regulatory aspects of clinical trials in accordance with Good Clinical Practices (GCP) requirements Experience in submissions of Proposed Pediatric Study Request (PPSR), deferral requests, study protocols and clinical study reports (CSRs) Experience with health authority meeting preparation Proven ability to independently manage critical projects as part of an interdisciplinary team. In addition, the candidate should have experience preparing, managing and submitting major regulatory submissions. Ability to successfully manage multiple projects to deadlines Experience with regulatory intelligence activities and pharmaceutical registration databases to support product approval strategies Note: This role can be flexible to locate in Chicago, IL or Redwood City, CA
AbbVie Illinois, USA
Feb 23, 2020
Full time
The role of the Business Services Group (BSG) Congress Account Manager (CAM) is to lead Global Congresses through successful project management, planning and delivery, while building strong working relationships with brand teams and medical affairs. You will be responsible for the end-to-end delivery and execution of complex large scale congresses along with other meeting and event activities utilizing standard process and procedures to achieve team happiness. Key Responsibilities Include: Communicate to the internal partner the services and value proposition of BSG. Assist internal partners to understand and conform to Abbvie and industry guidelines and standards. Participate in the annual planning / budgeting process. Identify all congress activity and provide assistance as required in budgeting for this activity. Preparation and tracking of budgets, throughout the lifecycle of each congress. Identify, quantify and report cost avoidance/savings measures on all congress elements. Conduct ongoing Congress/Event Team Meetings. These meetings should be scheduled: Monthly (T-10 to T-7),Bi-Weekly (T-6 to Event Date, Conduct BSG Management Update Meeting After full spectrum of congress and all associated activities have been identified, staffing and resources should be assigned and verified for all housing, venues, F&B, for all associated congress, symposium and ancillary meeting activities. Lead the creation and management of Micro-sites and event apps Coordinate the completion of the invitation and attendee management process per congress and other related congress meetings, including attendee management reporting in Lanyon Travel on-site to conduct site inspections and coordinate logistical suppliers and any internal staffing involved in congress activities. Run all congress requirements and on-site staff. Attend client debrief post congress. Basic: Bachelor's Degree in Business preferred/ marketing / Advertising / Hospitality Industry preferred. Equivalent successful industry experience (6 years full time planning) can be considered. 7+ years of work experience Ability to lead multiple project deadlines and knowledge of Project Management procedures. Strong critical thinking and negotiation skills Highly refined proactive and consultative skills along with attention to detail Ability to set priorities and multitask in fast-paced, multi-project environment, and learn new information quickly. Work well as a standout colleague, ambitious, ability to problem solve independently and in team situation. Knowledge of applicable regulations and standards affecting Pharmaceutical Products (e.g. CFR 210/211, cGMP) specifically, regulations and standards affecting the promotion of sales and marketing materials/samples and interactions with healthcare professionals. Good communication/presentation skills (both written and verbal) and ability to deliver results in a fast paced environment Shows high level of initiative to work independently
AbbVie Illinois, USA
Feb 23, 2020
Full time
Provide scientific and technical support for assigned products; deliver scientific presentations; develops and maintains professional and credible relationships with, key opinion leaders; actively participate in relevant Brand Teams and helps develop medical affairs strategies for assigned products; develop innovative research concepts for clinical data generation; provide relevant scientific and technical training. In cooperation with affiliate medical departments, Marketing, RA, Clinical and other functional areas, provides leadership, oversight and support for assigned products/projects. Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. Establishes and approves scientific methods for hypotheses, rational, design of affiliate protocols and their reports across different products. Oversee scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions. May act as scientific leader for several programs within an area. Drive Medical Affairs strategies and be a key internal contact/subject matter expert. May develop of scientifically accurate marketing materials, medical education programs, advisories, and symposia. May assist with the scientific review, development, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities. May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function. Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities Provides guidance to cross-functional team members to aid in the development of promotional materials. Provides timely and accurate reviews of promotional strategies and tactics in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs . Advanced Degree PhD, PharmD, PA, NP highly preferred. Residency or additional post doctorate experience is highly preferred. Typically 15 years' experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area required. Management or leadership experience at the program level, experience with strategy development; senior staff role within a TA. Proven leadership skills in a cross-functional global team environment International experience is a plus. Ability to interact externally and internally to support global business strategy. Ability to run a clinical program or medical affairs team(s) independently with littler supervision. Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in developmental strategy and the protocols. Must have an understanding of the Pharmacovigilance practices for Clinical Development programs. Ability to interact externally and internally to support global business strategy. Most possess excellent oral and written communication skills. Can address problems within discipline or across several projects. Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions. Works on complex problems in which analysis of situation or data requires an in-depth evaluation of various complex factors. Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions .
AbbVie Worcester, MA, USA
Feb 23, 2020
Full time
The Sr. Manufacturing Associate, New Product Introduction (NPI) will support New Product Introductions and program manufacturing readiness and will be part of the Business Unit 3 team. A key technical liaison for product transfer into manufacturing, the Sr. Manufacturing Associate will be responsible for batch record pre-review, batch record post-review, development modification implementation/processing, NPI metrics, NPI readiness, and technical on the floor support for clinical and commercial programs. The Sr. Manufacturing Associate will interact frequently with customers in many functional areas including Process Sciences, Protein Analytics, Manufacturing Sciences, Manufacturing, Tech Transfer, Quality, and Engineering to help ensure 'right the first time' new product introduction for clinical and commercial programs. The Sr. Manufacturing Associate complies with safety requirements, current Good Manufacturing Practices, and Standard Operating Procedures. Major Responsibilities Technical manufacturing lead for new product introductions for clinical, commercial, and PPQ programs for AbbVie internal and client programs. Primary manufacturing batch record review pre and post campaign for manufacturing batches. Works closely with cross functional team on the process development, batch record development, technical transfer, process fit/scale-up of new product introductions. Responsible for the successful transfer of products and processes into manufacturing. Provides feedback to Tech Transfer for batch records, performs on the floor review with manufacturing technicians, and assists with process fit into the manufacturing facility. Generates and/or reviews technical documentation with a focus on process, technical justification, and manufacturing readiness. Measures success through development of metrics and drives continuous improvement to improve agility for NPI. Evaluates data for trends, which may impact other systems, projects or areas. Applies knowledge, experience, and technical skills to understand production objectives and evaluate potential changes, implement production initiatives. Executes systems and procedures efficiently and compliantly and evaluates systems for improvement potential. Develops and uses standard practices to ensure inter-group consistency. Bachelor's Degree or equivalent is preferred. At least 5 years experience in aspects of manufacturing and production processes. Knowledge of media and buffer preparation, cell culture, and purification of biological drugs is required; Computer and scheduling expertise; Expertise with and continuous improvement of, tech transfer process; Adeptness with equipment, facilities validation, and regulatory policies; Significant functional group management. In-depth knowledge of safety, quality systems and Good Manufacturing Practices required. Able to make recommendations for improved compliance at plant level. Must be flexible to handle multiple tasks including ability to handle pressure in a professional and positive manner; Effectively works in a team environment; Maintains high level of energy and professionalism on the job; Build effective working relationships with customers, co-workers, cross-functioned groups, and management; Proactively and effectively participates in the continuous improvement process. Uses problem solving skills when working on complex problems, where analysis of situations requires an in-depth evaluation of various factors. Uses discretion and exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. Reports to a manager or higher. Coordinates the completion of programs and projects. Decisions, recommendations and actions are essential to the development of suite schedules and personnel allocation. Provides technical direction and training to less senior personnel; Coordinates activities of sub-group and actively works with other sub-groups. Acts as advisor to unit or sub-unit becomes actively involved as required. Participates in technical investigations and provides on the floor technical expertise; Provides a motivational and team building atmosphere. Acts as a mentor Frequently interacts with subordinates or functional peer groups at various management levels. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc. Regularly discusses progress, problems, and proposed solutions with colleagues and senior personnel
AbbVie Rockville, MD, USA
Feb 23, 2020
Full time
Key Responsibilities Includes: Deliver sales performance, brand key performance indicators, financial targets, marketing objectives, etc. in order to meet or exceed on those objectives. Build pre-call plan using SMART objectives and execute post-call evaluation to continuously improve sales performance. Effectively balance objections, misunderstandings, concerns and consistently gain logical and reasonable calls to action in order to close on every sales call. Actively and continuously seek to serve customer needs, customer expectations and challenges in order to build trusted customer relationships and to achieve successful agreements between AbbVie and customers. Develop and execute a call plan that achieves set call metrics and optimizes coverage and frequency to key customers in order to improve access and sales opportunities. Continue to develop understanding of customer needs and expectations, territory market landscape, competitors, market segments/dynamics, accounts, disease, product, clinical and sales expertise. Share this market intelligence information with in-field team, brand team and sales manager to stay aligned, to anticipate environmental changes and challenges and to optimize brand strategy and its execution. Differentiate AbbVie's value proposition with health providers and identify, develop and maintain disease state experts and speakers/advocates to improve brand performance. Bachelor's degree, biological sciences, pharmacy, business related field, or equivalent Consistent track record of success in selling and solid presentation skills Demonstrates in-depth scientific, therapeutic, product, and competitive knowledge and is recognized as an expert resource by all meaningful partners Strong eye for business and proficient use of business tools; possesses strategic and critical thinking capabilities. Actively identifies customer style / behavior and adapts quickly all aspects of selling approach Operates effectively in a matrix environment Offers innovative ideas and solutions to improve business opportunities to address challenges Provides impact with ideas for the larger organization and anticipates and responds to changes Influences others and is viewed as a credible and respected role model and resource among peers Builds collaborative partnership with district colleagues and matrix team, etc Leads by example; Consistently displays positive behaviors and peer mentoring through changing and challenging environments Documented success in leadership and support role of increased responsibility at the district, region and/or organizational levels Understands and uses findings to develop sales strategies
AbbVie Sunnyvale, CA, USA
Feb 23, 2020
Full time
As an AbbVie Summer Intern, you will participate in a paid, ten-week summer program that is focused on providing students with robust projects throughout the summer. As an intern, you will be located at our office in Sunnyvale, CA, with housing and shuttle services for eligible students. General Position: We are looking for two individuals to join the AbbVie Bay Area HR Team working on projects related to talent programs and culture efforts for a high performing, fast-moving bio-pharmaceutical organization. The internship is approximately 10 weeks in length and includes a final presentation of the project results to senior leaders and colleagues. The Business Human Resources (BHR) internship will provide you with access to industry experts and senior leadership. Additionally, there are numerous networking opportunities throughout the summer. Assignment Details : The intern will be exposed to the following work th r ough the partnership with BHR Leaders: Organizational development, talent acquisition, talent management, performance management, career development, employee relations, compensation planning and change leadership. These positions will be involved in projects related to change readiness for AbbVie's Bay Area move to South San Francisco, creating solutions to engage employees, build AbbVie's reputation in the Bay Area, as well as other culture initiatives that drive a "One AbbVie" Way of Working across diverse teams ranging from R&D to Commercial Operations. Basic: Completed at least one year of college education before beginning internship Currently enrolled and in good standing at an accredited University Undergraduate Level Student Be an active student in good standing at an accredited university Maintain a minimum cumulative GPA of 3.0/4.0 or equivalent Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship (students on an F1 visa with CPT can be accommodated). Preferred: Prefer individuals pursuing a four-year college degree focused in Business, Human Resources Management or related area of study. Academic, work experience or exposure to Human Resources and project management Ability to manage sensitive and confidential information Ability to prioritize and handle multiple tasks simultaneously Excellent organizational and planning skills Self-motivated, adaptable to a dynamic environment Able to collaborate effectively with cross-functional team members Strong analytical and communication skills Track record of accomplishment and commitment to excellence Proficiency in MS Outlook, Word, Excel and PowerPoint Final Presentation: Each Intern is expected to prepare a short presentation to their team to share what they have learned through their internship and how they hope their new knowledge will help them secure their future career. Presentations may be approximately 30 minutes long and should include visual aid (posters or PowerPoint).
AbbVie Illinois, USA
Feb 23, 2020
Full time
Responsibilities include all administrative functions of the department: answering phones, managing calendars, scheduling travel, managing correspondence and scheduling couriers, processing expense reports, planning meetings/events, creating or revising business documents, preparing presentations from source materials, handling teleconference, Web Ex and Blackberry/iPhone setups, managing billing, compiling meeting materials and other similar matters. Provides advanced administrative support to VP level or equivalent. May provide backup support to other staff as needed. Monitors and prioritizes executives email, highlights actions and routinely authors responses. Coordinates and maintains departmental files, as assigned, in compliance with corporate and legal guidelines. Follows company purchasing and other established procedures. Uses intermediate to advanced software skills to perform assigned work. Uses and understands Microsoft Office Suite and other business-specific software, including Corporate Travel website and other programs. Coordinates new employee office setups and onboarding. Professionally interacts with high level executives. Consistently handles confidential or business-sensitive information. Maintains and manages calendars, including meeting and travel scheduling and domestic and international travel arrangements. Proactively identifies and resolves scheduling conflicts. Minimum 3 years of administrative assistant related experience. High School diploma or equivalent. Experience providing support to a VP level or equivalent. Intermediate to advanced knowledge of Microsoft Office Suite, Outlook, Adobe Acrobat, understanding of business processes and requirements. Self-starter able to function at a high level with general instruction. Builds strong relationships with peers and cross-functionally with partners outside of assigned group as necessary to enable effective and efficient Legal team operations. Team-oriented, can-do attitude and desire to be productive contributor to overall organization. Learns quickly and can change course quickly when needed. Open to suggestions and innovation for improvement. Professional demeanor and ability to maintain confidentiality.
AbbVie Worcester, MA, USA
Feb 23, 2020
Full time
The Biologics Generation Group within Global Biologics is seeking a highly motivated research scientist to join the in vivo antibody discovery team at AbbVie Bioresearch Center (ABC). The ABC site, based in Worcester, MA, offers the unique setting where Biologics drug discovery, development and manufacturing coexist in one location! Our team interacts with multidisciplinary groups across AbbVie focused on developing therapies for Immunology, Neurology and Oncology diseases. We utilize innovative immunization approaches, advanced multiplex screening assays and outstanding automation platforms to enable successful antibody discovery against complex targets! As an integral part of the group, the ideal candidate will: Exercise proficiencies in mammalian tissue culture, molecular techniques, and binding assays such as ELISA and flow cytometry Execute all phases of in vivo antibody discovery campaigns by hybridoma generation or single cell isolation including immunizations, screening, cell culture and antibody characterization Analyze and document results, placing data in accurate scientific context through review of relevant literature and report findings at team meetings Demonstrate scientific excellence through dedication to multiple projects in a fast-paced multi-disciplinary environment Exhibit a can-do attitude with excellent interpersonal and communication skills to multiple teams across different functional areas Position will be hired based on knowledge and/or level of experience. Bachelors or Masters in Biology or other closely related field with typically 3-5+ (BS), or 0-3+(MS) years of industry or academic experience Knowledge of basic immunology concepts Understanding of immunoassays (e.g. flow cytometry and ELISA) Strong attention to quality and details when exercising organizational, documentation and interpersonal skills Proven flexibility to take care of changing timelines and shifting work priorities Proficiency with software programs, including MS Excel, PowerPoint, Word Preferred Qualifications: Experience with mammalian cell culture, aseptic technique is highly desired Experience in immunoassays using techniques like flow cytometry, ELISA and microscopy Animal handling experience (e.g. restraint, immunizations, tissue harvesting etc.) Familiarity with microfluidics and single cell analysis platforms
AbbVie Illinois, USA
Feb 23, 2020
Full time
AbbVie is seeking a highly motivated scientist to join our DMPK and translational modeling team in North Chicago. The ideal candidate will have strong background and expertise in pharmacokinetics and translational modeling. In this exciting role, you will be expected to participate in implementing innovative and quantitative approaches to advance translational sciences. The position will involve conducting mechanistic PBPK, human PK, and DDI projections to support Discovery and Development project teams, enabling compound progression from discovery to early stages of clinical development. You will also be expected to evaluate new technologies and approaches to support the mechanistic and translational understanding of drug disposition and drug-drug interactions. In addition, you will have opportunities to contribute to broader areas within DMPK by as your experience and expertise warrants. Core responsibilities include: Utilize PBPK and translational modeling tools to enable human PK projections Evaluate and guide novel in vitro tools and methodology to improve prediction of human PK Liaise with DMPK, discovery biology/pharmacology and clinical scientists to generate data and knowledge supporting the build-up of translational, mechanistic models Communicate effectively and clearly both internally and externally on topics related to PBPK, translational modeling and simulation, human PK and DDI prediction Keep up to date with emerging literature and science in modeling and in vitro approaches Basic Qualifications: Bachelors, Masters, or PhD with 0-4 (PhD), 8-10 (MS), or 10-12 (BS) years of experience in pharmaceutical or related field required. Preferred degree in Pharmacology or Pharmaceutical Sciences. Experience in DMPK and PBPK modeling and simulation, through academic or industry work Thorough theoretical and practical understanding of own scientific discipline Highly motivated, self-driven and results-oriented person with excellent communication and presentation skills, capable to work both as team player and independent scientific contributor Passion for data analysis, solving technical problems and applying new technologies to further scientific goals. Experience in modeling software, including SimCYP, GastroPlus, Phoenix and WinNonlin Key Leadership Competencies: Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance Learns fast, grasps the "essence" and can change course quickly where indicated Raises the bar and is never satisfied with the status quo Creates a learning environment, open to suggestions and experimentation for improvement Embraces the ideas of others, nurtures innovation and manages innovation to reality *Job level will be commensurate with experience
AbbVie Illinois, USA
Feb 23, 2020
Full time
AbbVie is at the forefront of cancer research, discovering and developing the next generation of treatments to address unmet medical need for cancer patients! Our strong pipeline includes both small molecule and biologic therapeutic approaches with first in class agents that target multiple pathways central to the growth and survival of both solid and hematological malignancies! We are seeking a highly motivated and accomplished in vitro biologist to join our growing cancer research organization. As a member of the team, you will be dedicated to discovering and developing novel cancer targets in the field of Immune-oncology. Key Responsibilities: Investigate, identify, develop and optimize assays and cellular models for interrogation of Immune-oncology biology, and perform standard biochemical, cellular and molecular techniques Generate reliable and reproducible data in a timely manner Interpret results and draw conclusions from own multistage experiments and suggest, design and pursue relevant experiments that further project goals Understand relevant scientific literature and apply theoretical framework to solving problems Independently schedule and prioritize workload to manage several tasks simultaneously and identify/ utilize resources outside of own group Efficiently coordinate and present scientific plans and data at project team meetings Work as part of a multidisciplinary research team in an exciting, fast-paced environment under the mentorship of a supervisor Position will be hired based on level of experience. Bachelors or Masters in cell or molecular biology, immunology, or related field with typically 5-7+ (BS) or 2-5+ (MS) years of experience Experience in Immune-oncology is a plus Broad and versatile technical skills in immunological, cell/molecular biology, and/or biochemical assays (FACS, ELISA, western blotting, cloning, cell culture techniques, immune cell function assays, etc) and assay development Demonstrate the ability to independently design, execute and interpret critical experiments Generating publication quality data and contributing to manuscript or patent preparation Highly developed interpersonal skills and keen ability to engage internal and external team members in collaborative research
AbbVie Sunnyvale, CA, USA
Feb 23, 2020
Full time
As an AbbVie Summer Intern, you will participate in a paid, ten-week summer program that is focused on providing students with robust projects throughout the summer. As an intern, you will be located at our office in Sunnyvale, CA, with housing and shuttle services for eligible students. General Position: We are looking for two individuals to join the AbbVie Bay Area HR Team working on projects related to talent programs and culture efforts for a high performing, fast-moving bio-pharmaceutical organization. The internship is approximately 10 weeks in length and includes a final presentation of the project results to senior leaders and colleagues. The Business Human Resources (BHR) internship will provide you with access to industry experts and senior leadership. Additionally, there are numerous networking opportunities throughout the summer. Assignment Details : The intern will be exposed to the following work th r ough the partnership with BHR Leaders: Organizational development, talent acquisition, talent management, performance management, career development, employee relations, compensation planning and change leadership. These positions will be involved in projects related to change readiness for AbbVie's Bay Area move to South San Francisco, creating solutions to engage employees, build AbbVie's reputation in the Bay Area, as well as other culture initiatives that drive a "One AbbVie" Way of Working across diverse teams ranging from R&D to Commercial Operations. Basic: Completed at least one year of college education before beginning internship Currently enrolled and in good standing at an accredited University Undergraduate Level Student Be an active student in good standing at an accredited university Maintain a minimum cumulative GPA of 3.0/4.0 or equivalent Must be authorized to work in the U.S. on a permanent basis without requiring sponsorship (students on an F1 visa with CPT can be accommodated). Preferred: Prefer individuals pursuing a four-year college degree focused in Business, Human Resources Management or related area of study. Academic, work experience or exposure to Human Resources and project management Ability to manage sensitive and confidential information Ability to prioritize and handle multiple tasks simultaneously Excellent organizational and planning skills Self-motivated, adaptable to a dynamic environment Able to collaborate effectively with cross-functional team members Strong analytical and communication skills Track record of accomplishment and commitment to excellence Proficiency in MS Outlook, Word, Excel and PowerPoint Final Presentation: Each Intern is expected to prepare a short presentation to their team to share what they have learned through their internship and how they hope their new knowledge will help them secure their future career. Presentations may be approximately 30 minutes long and should include visual aid (posters or PowerPoint).
AbbVie Illinois, USA
Feb 23, 2020
Full time
Works with business unit clients to understand specific business processes and business drivers and business strategy across multiple business units; identifies and communicates resulting needs and opportunities for business process improvement that can be enabled via technology; investigates and understands capabilities of existing systems and technologies already in use across the business area and similar and interconnected business areas in AbbVie and investigates available technologies. Identifies information required to support the business strategy and leads the development of appropriate information management strategies, developing them as an integrated part of the business strategy. Identifies, proposes, initiates and leads significant improvement programs across multiple business areas establishing requirements for the implementation of significant changes in business functions and processes, organizational roles and responsibilities and scope or nature of technology. Responsible for compliance with applicable Corporate and Divisional Policies and procedures.Identifies current and emerging business needs and evaluates alternative technology solutions using standard information systems methodologies and best practices. Proactively seeks out strategic business opportunities for the application of new or existing technology capabilities (across multiple business areas) with high-level business unit executives providing key opinion-leading clients with comprehensive strategic analyses and insights to help them discover strategic uses of technology products and services. Develops, leads, or reviews the creation of information systems strategy to support the strategic requirements of multiple business areas. Identifies the business benefits of alternative strategies. Ensures compliance between business strategies and technology directions. May prepare testing plans to confirm that requirements and system design are accurate and complete. Conducts training. Makes recommendations to process stakeholders regarding the correct approach to achieve process improvement objectives. These may include business process outsourcing, application development or adopting business process management (BPM) practices. Develops business relationships and integrates activities with other BTOs to ensure successful implementation and support of project efforts. Manages relationships between clients involved and BTOs to assure effective communication between the groups is occurring. Brokers services within BTS on behalf of customers; coordinates portfolio of solutions, and identifies interdependencies. Allies with other BTOs to remain current on project status, and inform customer management of progress; conversely, keeps BTS managers aware of user issues and resolves conflicts. Identifies the impact of any relevant statutory, internal or external regulations on the organization's use of information. Establishes and maintains productive relationships with all levels in BTS and with external partners. Acts as a liaison and business process expert to BTOs to assure successful implementation. Serves as a source of information to the service organizations on the business drivers, processes and organization structure and dynamics of multiple business areas. Has defined authority and responsibility for a significant area of work, including technical, financial and quality aspects. Establishes organizational objectives and delegates assignments. Accountable for actions and decisions taken by self and subordinates. Accountable for the accuracy of the fit of the proposed business process improvements and the technical solution to the business needs and the information upon which the business justification and prioritization decisions are made. Bachelors Degree or an equivalent combination of education and work experience. 12-14 years of related work experience. Exercises latitude in the approach to problem solving. Work checked through consultation and agreement with others rather than formal review by superiors.
AbbVie Illinois, USA
Feb 23, 2020
Full time
The Director, Health Economics and Outcomes Research (HEOR), Immunology will lead early launch preparation strategies and tactics for a new asset/indication in Gastroenterology. The Director will ensure HEOR functional project plans integrate and align with the broader asset strategic plans from cross-functional teams to support/maintain AbbVie's leadership in immunology. The Director will execute projects that have meaningful impacts to asset teams, provide updates to functional management on these plans, and will represent HEOR at appropriate immunology leadership meetings. In the development of product strategic plans, the Director will liaise with other members of the immunology team (both US and internationally-based) to generate innovative ideas and create alignment on strategies. Key Responsibilities Include: Leads the development of strategic plans and studies to support upcoming project launches and improve patient access all within a highly matrixed, team environment Effectively communicate study findings to internal (Executive Leadership, Area VPs, GMs etc.) and external (e.g., HTAs/Payers, patient (advocacy groups) and KOLs etc.) audiences Designs and executes all aspects of US/international HEOR projects, including writing RFPs, vendor selection, and management including budget Executes HEOR research using internal data sets including writing protocols/statistical analysis plans, defending in protocol review committee, executing research with analysts, and writing final reports or publications Partners with development team to determine HEOR strategies including inclusion, analysis and validation of quality of life or patient reported outcomes in development plan Sets the strategic direction of the brand in partnership with the integrated brand teams focusing on the impact of evidence generation to solve complex issues Maintains awareness of regulatory legislation and assesses its impact on business and AbbVie product development programs Proficient at economic modeling and generation of strategies and evidence to support launches Basic: PhD in Health economics, pharmacoeconomics, health services research, public health or related field with at least 5 years of experience. Will consider MD, PharmD, or MS in Economics, Econometrics, or (pharmaco) epidemiology or any other related field with at least 7 years of relevant experience. Level commensurate with experience - will consider Associate Director and Director level candidates based on experience Previous experience within the immunology therapeutic area, at least 1 year strongly preferred Experience with both US and global regulatory and HTA reimbursement/market access requirements Experience leading HEOR strategies and tactics in support of pipeline development and on-market product support Possess both strategic and tactical skills in executing HEOR Seeking a proven leader within HEOR and the pharmaceutical industry to complete a top performing team in immunology
AbbVie Illinois, USA
Feb 23, 2020
Full time
The Director of R&D Communications is responsible for the oversight and management of strategic planning and execution of external communications and internal leadership and functional communications supporting AbbVie's R&D organization, specifically for the Chief Scientific Officer and the R&D Leadership Team. This includes responsibility for leading R&D communications across all our therapeutic areas of focus (oncology, immunology, neuroscience and virology) and our research sites globally. The Director partners with the senior leaders across R&D to understand their priorities and develops and executes strategic, compelling communications programs that deliver on R&D and enterprise wide objectives. The Director must be able to think strategically and be a strong counselor to senior scientific leaders. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Core Job Responsibilities Leads strategic counsel to R&D leaders and execution of programs that support telling our early asset and pipeline story Serves as primary communications contact for the Chief Scientific Officer Ensures all communications efforts ladder up to broader R&D story Works closely with brand communications team on programming across therapeutic areas of focus Serves as strategic lead on annual events and programming designed to tell our innovation story Develops and implements the internal leader communications plans Develops and implements strategic communications in support of R&D centers globally Coordinates closely with communications and HR counterparts at R&D sites to provide strategic counsel on local communications initiatives that support broader R&D goals Contributes as a core member of the R&D team, assisting with annual planning, budget oversight and development of initiatives to support broader R&D and enterprise wide goals Develops creative, compelling content and presentations for both internal and external audiences that helps tell our R&D narrative both internally and externally Provides strategic communications counsel and support for key functional priorities and initiatives Interfaces and aligns with various division and corporate constituencies, including government affairs, investor relations, legal, finance, marketing, regulatory, medical, clinical and senior management Effectively manages various stakeholders within R&D and cross-functionally on planning and execution of relevant communications initiatives Oversees management of agencies that support R&D communications Works with key R&D leaders on message delivery, media engagement and external speaking opportunities Identifies strategically compelling external speaking opportunities for R&D leaders to further demonstrate AbbVie's leadership in R&D Finance/Administrative: Ensure proper adherence to all financial and administrative policies. Ensure programs fall within budget parameters and all paperwork is completed in appropriate manner (invoice logging, purchase orders, statements of work, etc.) A bachelor's degree in journalism, public relations, communications, business, marketing or related field is required. More than 12 years of experience in the development and execution of communications programs with previous leadership positions and specific experience working with senior leaders. Must have proven writing, verbal and problem-solving skills and demonstrated success in developing and executing a wide range of internal and external communications. Previous work in the biopharmaceutical R&D or related industry is preferred, but not required. Experience and interest in managing teams and multiple direct reports is also desire d.
AbbVie Illinois, USA
Feb 23, 2020
Full time
Provides consistent and thorough exception documents and timely resolution of investigations based on CAPA requirements Coordinates the exception document process and creates exception documents Independently leads complex, high impact investigations Ensures all investigations are written according to corporate and site requirements Ensures all applicable regulatory requirements are met for the implementation and maintenance of the Quality System Ensures all Quality CAPA goals and metrics are met Promotes culture of continuous improvement by identifying problems, conducting root cause analysis and confirming appropriate implementation of corrections, corrective and preventive actions Maintains an effective liaison and cooperative relationship with other Quality areas and departments within the plan t Bachelor's degree, preferably in one of the following areas: Biology, Chemistry or Engineering 6+ years of experience in the pharmaceutical or medical device industry in Manufacturing, Quality or Engineering Demonstrates ability to problem solve and utilize analytical skills Knowledge of Quality/Compliance management, Regulations and Standard s
AbbVie Illinois, USA
Feb 23, 2020
Full time
Provide subject matter expertise of product coverage, insurance benefit coverage, AbbVie sponsored co-pay cards and alternative forms of coverage for supported products. Assists patients with treatment compliance by scheduling and entering medication orders into the pharmacy information system. Enter patient demographic, health insurance, specific clinical/financial information, and prescription information into the pharmacy information system and notify the physician of any incomplete or incorrect prescription information; captures and updates patient Medical Profiles including medications, allergies, and medical conditions. Assist the pharmacist in the practice of pharmacy in accordance with federal, state, and local regulations, HIPAA guidelines, and corporate and departmental policies and procedures. Meet performance standards in alignment with predefined metrics. Contact patients to inform them of benefits and estimated out of pocket expense. Identifies potential Adverse Event situations for reporting to Pharmacovigilence ensuring AbbVie meets FDA regulations. Completes all required training perform all functions in the position e.g., Soft Skills certification, product and disease overviews. Maintain current pharmacy technician licensure and CE requirements as necessary . High School Diploma or GED required. Associate or College Degree Preferred. Individuals must meet applicable Pharmacy Technician licensure and certification requirements at employment start date in accordance and compliance with the Illinois Pharmacy Practice Act. Previous experience in a call center environment, healthcare office, corporate setting, or healthcare insurance provider or pharmacy is highly desirable. Previous experience as a pharmacy technician, especially in a specialty pharmacy or mail-order pharmacy setting, is desirable. Understanding and knowledge of commercial and major medical insurance programs, billing requirements, healthcare benefit investigation processes, prior authorization and appeal filings. Must have accuracy, attention to detail, and fluency in the use of computers. Ability to type at least 30 words per minute. Must have organization and problem solving skills to handle patient conversations identify issues and address needs. Must be proficient with Microsoft Office Program Suite and Lotus Notes Suite including Excel, Word, Outlook and SharePoint. Must have knowledge of private payers, pharmacy benefits, medical benefits, Medicare Part D, Medicaid and alternate funding resources. Ability to maintain professional communication skills and an understanding of how to maintain a courteous attitude toward customers and fellow employees .
AbbVie Illinois, USA
Feb 23, 2020
Full time
The primary function of this position is to provide technical and administrative support to the EHS Laboratory Services group within the AbbVie EHS organization. This position interacts with EHS lab personnel and customers, shipping and delivery personnel, purchasing and accounts payable, records management, and external subcontract laboratories. Performs basic laboratory upkeep and maintenance duties, sample receipt and login, ordering supplies, maintenance of records, and documentation upkeep. Major Responsibilities: Receive and log in samples. Examine incoming samples for appropriate collection, storage and shipping. Resolve inconsistencies with sample identification or other problems related to chain of custody. Ensure appropriate laboratory storage of received samples. Utilize Global IHDA to electronically input, receive, and log in samples for analysis. Prepare and route sample documentation to appropriate analyst or subcontract lab as appropriate. Prepare sampling media and equipment and distribute or ship to lab customers. Assemble media corresponding to catalog number. Use an analytical balance to weigh out and transfer salts to bottles to prepare kits for water sampling. Perform domestic and international shipping of sampling supplies (media and equipment) to customers. Perform basic laboratory operations. Perform verification checks on basic lab equipment, pipettors, thermometers, etc.. Perform laboratory maintenance and upkeep activities including: sampling media inventory, sampling equipment for loan program, periodic lab safety checks, and washing laboratory glassware. Receive and log lab chemicals and supplies. Participate in the lab's Quality Assurance Program. Maintain training on applicable quality system documentation. Conduct responsibilities in accordance with the lab's standard operating procedures (SOPs). Perform administrative activities including: paying invoices from blanket purchase orders for service suppliers, maintaining and ordering office supplies, and coordinating records archival and retrieval. Education: High school diploma or equivalent + 3-5 years relevant experience. Background: Basic to intermediate proficiency in PC software including SAP, Microsoft Office Suite, Adobe Acrobat, and Outlook. Must be able to populate and navigate through job designated software, including Global IHDA for field and lab generated sample data entry, Oz or equivalent shipping request system, supply procurement systems (Office Depot, Symphony, etc.), and various courier shipment tracking systems such as FedEx, DHL, etc. Accountability / Scope: This is an individual contributor position with no direct reports. The position operates under some form of laboratory supervision (higher level lab technical personnel or lab management), but can self-manage their time and priorities on a daily basis. Responsible for following laboratory procedures and completing required training on a timely basis. Responsible for generating and documenting
AbbVie Illinois, USA
Feb 23, 2020
Full time
The function of the GMP Vendor Auditor is to provide direction and perform evaluations for compliance with US and foreign regulation requirements (minimally may include the Americas, Asia, Africa, Australia, European Middle East regions), and provide constructive evaluation of quality related systems for suppliers that provide materials, services, and products to AbbVie and AbbVie plants. Suppliers can include API suppliers, contract labs, excipient suppliers, commodity suppliers and third party manufacturers. The Auditor is also responsible for providing support to AbbVie plants in the resolution of issues related to suppliers. Their direction and execution in the area of GMP compliance and quality assures that activities are performed and detailed in accordance with AbbVie policies/procedures and applicable quality and regulatory requirements intended to assure the quality, efficiency and safety of our products. Assesses compliance of systems, facilities, and procedures per applicable regulations through audits and assessments, assuring compliance to regulatory requirements and AbbVie specifications. Provides feedback in the form of audit observations, formulate recommendations, and review corrective actions to determine if corrective actions have been properly implemented, proven to be effective, and are being maintained. Primarily focuses on key suppliers whose processes are more comprehensive and critical to the business and will include participation in audits of AbbVie plants. Serves a tactical purpose for AbbVie and must achieve a difficult balance of involvement and objectivity. Participates in strategic initiatives to improve compliance and standards. Independently plan and conduct internal system audits and external GxP supplier audits. Maintain approved supplier list, global audit schedule and participate in supplier management processes. Gathers internal and external audit metrics and presents to QA management for trend analysis. Provide guidance and training on GxP regulations and guidelines to GxP auditors and functional area personnel. Bachelor's Degree preferably in technical or scientific area (Chemistry, Pharmacy, Biology, Microbiology, or Engineering) or equivalent industry experience (at least 6 years) with sufficient exposure to pharmaceutical, medical device, or combination product related industries. Must have a technical background and requires a thorough understanding of the audit process and an extensive knowledge of worldwide requirements related to GMP regulations for quality systems and compliance. Must understand a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, support and service and understand the principles of quality management. The individual must have excellent oral/written communications skills. Personal skills needed include interpersonal skills, leadership, tact, open mindedness, maturity, tenacity, decisiveness, self-reliance, organizational/administrative skills and sound judgment. Persuasive, effective communication skills are essential with an ability to work effectively outside of the company and across divisional and technical areas. 4+ years in Quality Assurance with some management experience preferred and two more years in another function in the pharmaceutical, medical device/nutritional or related industry. Two years in compliance/auditing or regulatory affairs is desirable. Total combined experience expected to be at least 8 years. ASQ certification desired . Travel: 25%
AbbVie Illinois, USA
Feb 23, 2020
Full time
The Therapeutic Area Program Manager facilitates the worldwide execution of the HEOR strategies and financial plans for assigned therapeutic area(s) in collaboration with the HEOR TA Leads, Study Leads, and across HEOR Operations. This position is a leadership role responsible for completing complex assignments and providing supervision to direct staff (as applicable) and general mentorship, training, continuous improvements, and support to Operations and the HEOR function. Key Responsibilities Include: Responsible for specific therapeutic area operations: External budget tracking and communication (e.g. LBE); compliance and contracting oversight for assigned TA projects, purchase order and invoice approvals, accrual tracking, transparency reporting, and issue resolution. Coordinates and communicates project/process issue resolution with finance, purchasing, legal, OEC, CCG, GPC management. Provides project information, reporting, and tracking to support planning cycles (e.g., Portfolio/Plan, Compliance Annual Plans), including oversight of ad-hoc and routine requests. Provides external budget roll-up and general project management support to HEOR TA VP(s). Leads contracting process and/or budget tracking for specific TAs. Addresses issues, finds compliant solutions for anomalies. Liaises with OEC, Legal, Finance, and Purchasing for project-level issue resolution. Continuously monitors projects and budgets for slippage or issues that require resolution and communicates issues with management and TA leads. Documents lessons learned to ensure consistency across TAs. Provides oversight and interpretation of compliance, financial, purchasing, and/or transparency requirements to deliverables, invoices, and contracts. Critically assesses vendor proposals to ensure compliance and study success. Oversees TA contract/publication prioritization and impact of queue to external budget (LBE, year-end accruals). Compliance: Interprets and provides mentorship on AbbVie policies and procedures, OPPF, and individual state and country compliance measures and guidelines for working with HCPs/suppliers. Assists Operations PMO in implementation of department compliance initiatives (including SOP development), training, implementation, monitoring, and audits with minimal supervision / oversight. System Development/Maintenance: Provides user requirements and recommendations to implement and improve systems to automate processes. Promotes consistent application of system governance and aids in troubleshooting anomalies. Basic: Required: Bachelor degree; prefer focus in Science, Computer Science, Business, or Project Management Preferred: MA/MBA/MS or PhD Prefer 3-5 years previous relevant experience, program/project management or CRA experience preferred, including leadership of a cross-functional team. Demonstrated ability to handle and prioritize various aspects of scientific studies, including project start-up, compliance documentation, budget management, study deliverable and timeline management, and project closeout. Prefer contracting, compliance, and/or accounting experience. Proficient in the tools and approaches of Project Management and / or Business Excellence; Proficient technology skills (e.g., MS Office software, SharePoint Skills). Prefer management/supervisory experience; ability to manage and lead teams in matrix environment. Ability to work independently. Strong written and interpersonal communication, conflict resolution, problem solving skills, and decision-making. Ability to clearly present, influence, and logically justify positions/proposals. Ambitious. Strong interpersonal skills with a focus on details. Drug development, process or project management related experience. Cross-functional and global project team leadership experience.
AbbVie Illinois, USA
Feb 23, 2020
Full time
The Finance Lead, Expense Management reports to the Associate Director, Global Commercial Finance - Expense Management and is responsible for providing financial support to the Global Immunology organization. This role will get along with multiple cross functional partners to generate and consolidate Latest Best Estimates (LBEs), Plan and Update. Additionally, this position will partner with key members of the team to implement process enhancements, develop new tools to lead and assess Immunology budgets & performance and support the Associate Director on ad-hoc analyses as needed. Key Responsibilities Include: Preparation and consolidation of GMCO LBEs, Plan and Update Preparation of monthly Financial Reporting Package, key Sales reports and budget overviews Planning & analysis of Functional expense and Headcount for Immunology Presentation of monthly actual variances and budget risks & opportunities Preparation of material for Investor Relations to support quarterly earnings call preparation Assist with financial process and reporting training Ad-hoc analysis as required Basic: Bachelor's degree in Finance or Accounting. 5+ years of relevant finance/accounting experience. Strong financial, analytical and problem-solving skills. Strong communication skills (oral and written). Ability meet tight deadlines while balancing competing priorities. Ability to work well in a team environment and build strong relationships with cross-functional stakeholders. Strong Excel and PowerPoint skills. Knowledge of SAP and TM1 a plus.