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Job Summary Responsible for assisting the team with regulatory filings as necessary to market Zimmer Biomet products. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission process Principal Duties and Responsibilities Assist with assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions. • Respond to requests from foreign government and/or distributors as needed •Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products •Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products •Evaluate risk of proposed regulatory strategies; may offer solutions •Reviews proposed labeling for compliance with applicable global regulations •Writes and manages the development of package inserts •Reviews and evaluations promotion and advertising material for compliance with applicable regulations •Reviews proposed product changes for impact on regulatory status of the product •Communicates with regulatory and governmental agencies with supervision •Applies FDA regulations to business practices and provides regulatory input, advice and guidance to design teams This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act. Expected Areas of Competence •Strong writing, communication, and interpersonal skills •Strong attention to detail; ability to multi-task and balance competing priorities •Knowledge of overall business environment, the orthopaedic industry, and the marketplace •Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional area •Ability to building relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels •Knowledge of FDA, EU, and other regulatory body regulations •Ability to identify risk in Regulatory strategies •Strong problem solving skills •Effective negotiating skills •Basic computer skills, including Microsoft Office Suite Education/Experience Requirements •Bachelor's degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred •A minimum of one year of experience in orthopaedic or medical device industry preferred •A minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or related field required •Regulatory Affairs Certification (US or EU) preferred •A combination of education and experience may be considered Travel Requirements Up to 15% Additional Information EOE/M/W/Vet/Disability

Position Information Position Title Assistant Director for Public Interest and Government Requisition Number STFR005071 Division/College School of Law Interdisciplinary Division/College Location Boston Main Campus Full-time/Part-time Full Time Grade 11 Posting Date 11/15/2018 Responsibilities The Assistant Director of Public Interest and Government ("Assistant Director") is a full time position and will function as an integral part of the three-member Public Interest and Government Advising Team within the Center for Co-op and Career Development. The Assistant Director will provide comprehensive co-op advising, career advising, and professional development programming for law students seeking Public Interest and Government jobs, and for other law students as assigned. The work of the Assistant Director will fall primarily in three areas: (1) the co-op experience and post-graduate job search; (2) employer outreach, which includes developing and maintaining connections with public interest and government employers across the country and worldwide; and delivering programming related to the co-op/ post-graduate job search process; and (3) professional development programming. Additionally, the Assistant Director collaborates regularly with the greater law school community, including faculty, staff and student organizations. Student Advising: The Assistant Director supports students through all stages of their co-op experience and entry-level job process: individual planning sessions for application strategy, resume and cover letter review, job interview preparation, advice regarding co-op selection and post-graduate job applications. This position works closely with our co-op employers, who are our partners in helping our students grow professionally through the co-op process. Employer outreach: The Assistant Director develops relationships with new employers, helps them to identify placement needs, assists them during the placement process and provides guidance during the co-op on supervision questions. Program and Professional Development: The Assistant Director is responsible for delivering programs on range of topics, from interview preparation to substantive areas of public interest law. The Assistant Director also regularly creates communications to students, professional development materials and job search guides, employer support materials, and various office publications. Northeastern University School of Law's Center for Co-op and Career Development is both a student services and an employer relations office. As such, there are occasionally evening and weekend events that require staffing. The Assistant Director is expected to work as needed during evening and weekend events in order to support student networking and employer outreach. The Assistant Director may also be asked to participate in events for prospective and admitted law students. Qualifications The Assistant Director must have a J.D. and at least five years of professional experience in public interest or government law. Demonstrated experience in mentoring or advising law students or entry-level lawyers is strongly preferred. Demonstrated ability to work with individuals from a wide range of backgrounds coupled with a commitment to supporting the career goals of a diverse student body. The candidate must have excellent verbal and writing skills and be technologically savvy and proficient in MS Office, including Excel and Powerpoint. Fluency in social media avenues a plus. Ability to work effectively with a diverse student body, a wide range of employers, and the internal law community is essential to success in this position. Additional Information

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that I agree with Takeda's Privacy Notice , Privacy Policy and Terms of Use . Job Description OBJECTIVES: Responsible for regulatory activities supporting the development of vaccine candidates in the US and Canada. Manages regulatory projects and submissions for vaccine candidates Ensures that all necessary applications are filed and maintained in compliance with applicable regulations. Leads and directs the work of others as part of a matrixed organization. Provides regulatory oversight for assigned projects, focused on non-clinical and clinical aspects of drug development and associated regulations. Collaborates with all Takeda regulatory counterparts to ensure global regulatory alignment for all projects within area of responsibility. ACCOUNTABILITIES: Co-ordinates and is accountable for all Health Authority submissions and approvals within area of responsibility. Has a quality focus so that submissions are right-first-time. Acts as primary regulatory authority contact for projects of responsibility. Coordinates interactions with and submissions to FDA. Communicates effectively the outcome of Health Authority interactions and provides analyses of potential impact. Ensures compliance with both internal Takeda process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication. Acts as US regulatory content and procedural subject matter expert to internal stakeholders on matters related to regulatory affairs activities in the US and Canada. Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations. Accountable for overall content and management of local regulatory components and filings i.e. NDA/BLAs, INDs. Contribute to overall strategy and content for local label development. Responsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members. Actively participate as member of Global Regulatory Teams supporting products. Responsible for US specific documentation supporting development and maintenance of products and ensuring filings meet local regulatory requirements. Leads and manages health authority meetings as applicable for specified projects. EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS: BS degree, advanced scientific degree preferred. A minimum of 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 8 years regulatory and/or related experience in the vaccine area. Vaccines and/or biologics experience is strongly preferred. Preferred experience in managing filings resulting in first-time approval; or managing programs in closely related development area. Relies on extensive experience and judgment to plan and accomplish goals. Understands and interprets complex scientific issues across projects and area(s) of responsibility as the issues relate to regulatory requirements and strategy. Generally strong in all basic skills sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. Must be strong overall in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Exceptionally strong in the following areas: working well with others including on cross-functional teams and communication with leadership. PHYSICAL DEMANDS: Manual dexterity required to operate office equipment (i.e. computers, phones, etc.). Carrying, handling and reaching for objects. Ability to sit or stand for long periods of time while traveling. TRAVEL REQUIREMENTS: Willingness to travel to various meetings, including overnight trips. Some international travel may be required. Requires approximately 20 % travel. Empowering Our People to Shine Learn more at takedajobs.com . No Phone Calls or Recruiters Please. *LI-KB1-USA Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time

Our client is a late-stage biopharmaceutical company engaged in the development and commercialization of human therapeutics. They have asked us to assist them in their search for a Director, Global CMC Regulatory Affairs. The Director, Global CMC Regulatory Affairs is responsible for leading all regulatory CMC development, registration, and compliance activities from early development through commercialization. Major tasks and responsibilities will include: Works closely with colleagues and cross-functional project teams to develop CMC regulatory submission strategies, review content, and maintain submission timelines to successfully meet business objectives. Assesses and communicates CMC regulatory requirements. Ensures all development activities are in compliance with applicable regulations and guidelines. Works with CMC colleagues to develop Quality by Design (QbD) strategies for novel manufacturing processes. Assists in the conduct and appropriate documentation of all QbD related activities. Conducts risk assessments and develops mitigation strategies for global CMC regulatory matters. Leads efforts for developing all CMC content of original INDs, IND amendments, investigational medicinal product dossiers (IMPD), and NDAs. Interfaces with regulatory agencies on all CMC matters. Leads preparations for regulatory agency CMC meetings. Effectively communicates novel manufacturing processes and QbD activities to regulatory agencies. Works closely with Manufacturing and Quality colleagues to prepare for GMP facility inspections by health authorities. Ensures all corrective actions are completed, documented, and properly communicated. Ensures that CMC-related changes are reported in a timely manner to health authorities in accordance with regulatory requirements. Establishes, manages, and maintains a knowledge base of current and emerging global CMC regulatory requirements and guidelines. Ensures overall operation is within the approved budget and timeline. We seek candidates with the following qualifications: Bachelor's degree in chemistry, biochemistry, engineering, life sciences or related field required. Advanced degree highly preferred. A minimum of 10 years of CMC regulatory experience in the pharmaceutical industry. Must have strong knowledge of drug development, with some small molecule experience. Requires understanding of and experience with pharmaceutical QbD concepts and techniques. Must have excellent knowledge of FDA and ICH requirements and guidelines, with experience as FDA liaison. Knowledge of EU regulations and guidelines highly preferred. Requires experience in authoring and filing INDs, IMPDs, and NDAs. Experience in post-market and commercialization regulatory CMC activities required. RAC certification highly preferred. Must have proven evaluative, analytical, and interpretative skills enabling review and synthesis of information used in regulatory planning and submissions. Demonstrated project management skills required. Must be capable of multi-tasking, setting priorities, and meeting timelines in a fast-paced, innovative environment with minimal supervision. Supervisory oversight of contract service providers, external consultants, and in-house project teams required. Must be able and willing to travel up to 10%. If interested, please email your resume as a Word attachment to us, reference 3857. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email. Fairway Consulting Group is included in Hunt Scanlon's list of Top 50 Healthcare & Life Sciences Search Firms.

Company Profile: Staubach & Associates recruits nationwide in Transportation, Supply Chain, Engineering. See additional job postings on our website - Job Description: This position is for local residents only. Requirements: • BS Degree in one of the Sciences: Bio or Chemistry • Minimum ten years regulatory management experience significant to medical technology devices in a regulated industry • PMA Submission Experience • Track Record of success leading products through the regulatory approval • Excellent Communication Skills Major Tasks & Responsibilities: • Budgeting • Understanding of design controls, quality systems, safety regulations and risk management • Responsible for developing and managing the regulatory strategy for current and future self - assembling material-based products - timely and scientifically valid - in various geographic jurisdictions • Periodic Reporting Requirements • Manage quality regulatory strategy for filings and communication for medical devices • Start Up Experience Excellent Salary, Bonus and Stock Options. Local candidates only - No company paid relocation.

Job Description JOB DESCRIPTION Under the supervision of the Contract Manager, this position supports the Security of the US Judicial complex, and the safety of the judicial family and the general public utilizing the US Courts. The Court Security Officer (CSO) will observe and report activities and incidents at assigned locations, providing for the security and safety of client property, visitors, and personnel. The officer preserves order and may act to enforce regulations and directives for the site pertaining to personnel, visitors, and premises. The CSO is responsible for ensuring the safety of federal courts and court employees against unauthorized, illegal and potentially life-threatening activities. At a minimum, CSOs are required to perform the following functions: Entrance Control, Roving Patrol, Stationary Patrol Assignments, Escort Duties, Garage Parking and Pedestrian Control, Law and Order, Reports and Records, Court Attendance, Preserve Order, Lost and Found Requirements JOB REQUIREMENTS Minimum of a GED/High School Diploma. Top Secret Clearance is Required At least three calendar years of verifiable experience as a certified law enforcement officer or its military equivalency; all three years must have occurred within the last seven years. The experience must have included general arrest authority. Must have completed or graduated from certified Federal, state, county, local or military law enforcement training academy and able to provide certification as proof. Ability to use computers and Microsoft office (Excel, Word, etc.), monitor security cameras, and send and receive email using MS Outlook. Must be a US Citizen with valid Social Security Card; birth certificate; 21 years of age; Due to the nature of the position, the CSO must be fluent in speaking, reading, and writing English. Ability to follow established procedures and policies. Post orders to include enforcement of client/company rules, policies, and/or regulations. Must possess excellent attention to detail, good verbal and written communications, including legible report writing. Ability to provide excellent Customer Service. Ability to analyze and produce course of action reporting and escalate issues to management in typical and crisis situations. Ability to work independently or as part of a small group to resolve urgent issues, process orientated with high attention to detail, and triage a problem quickly providing precise/clear information while working under minimum supervision. Ability to perform essential functions of the position which may include long periods of sitting, walking, standing, climbing stairs, or driving with or without reasonable accommodations. Ability to see, hear, and smell in order to respond to alarms and detect emergency situations. Must be reliable and have a strong work ethic. Must have a valid driver's license from state of residency and a safe driving record for the past five years Must be able to pass a background and credit check covering the last 10 years and pass a drug screening due to the nature of the position. Must meet and maintain medical standards as specified by the United States Marshal Service (USMS); the physical demands are based on the contract and must be met by an employee to successfully perform the essential functions of this job. EOE/M/F/Vets/Disabilities Employer We Participate in the e-Verify Employment Verification Program

The Environmental Officer is the shipboard subject matter expert on environmental regulations, and the ambassador for the company's "Save the Waves" program. He/she oversees and assists in the development of the company's environmental policies, procedures, and systems; and ensures the compliance of every ship with all applicable environmental laws. The Environmental Officer must be familiar with environmental quality standards, marine regulations, and current maritime environmental issues. Applicants with a degree in environmental management, science, or engineering, and previous experience in a similar role are preferred.

Job Description: • $1000 sign on bonus with valid NYS Pistol permit. Pay rate is $15.00 per hour. Driving automatic and/or standard shift vehicles from 8,000 to 36,000 pounds gvw a minimum of 4 hours per day, 5 days per week, in accordance with a designated route, making stops at a minimum of 30 customer locations. • Servicing ATM machines on a set schedule, including re-supplying replenishing, retrieving deposits, and monetarily balancing the machine. • Picking up/delivering customer change orders/deposits carrying a minimum of 50 pounds by hand or up to several hundred pounds by cart, a minimum of 30 stops per day for a minimum of 4-5 hours, 5 days per week. • Loading/unloading vehicle cargo consisting of multiple bags and boxes of coins, weighing as much as 50 pounds per item, 5-6 days per week. • Counting items, recording amounts and serial numbers, signing and dating receipts and manifests, sorting individual cargo items by route. • Communicating with customers verbally on-site and via telephone and two-way radio, to report emergencies and to approach the Loomis Armored facility. • And other duties assigned. Skills / Qualifications Required: PERFORMANCE REQUIREMENTS: • Must have a valid New York State pistol permit. • Ability to repeatedly perform heavy lifting and carrying items by hand in an unrestricted manner for significant distances (several yards). • Ability to push/pull dollies/carts loaded with cargo weighing up to several hundred pounds. • Unrestricted ability to bend, stoop, squat, stand, walk, climb, twist, turn and reach out. • Ability to operate a motor vehicle safely in accordance with Driver Physical Qualifications established by the US Department of Transportation, Federal Highway Administration. • Ability to read and speak the English language sufficiently to converse with general public, to understand highway traffic signs and signals in the English language, to respond to official inquires, and to make entries on reports and records. • Ability to sign and record numbers by hand. • Ability to count, record, add, subtract, and balance columns of numbers. • Ability to operate large automatic shift vehicles. • Ability to meet state requirements for handgun license/permit or Security Officer Commission. • Good attendance and punctuality. • Ability to interact constantly with co-workers, customers, and the general public. • Ability to handle change in sequence and routine on short notice. WORKING CONDITIONS: • Full-time schedule possibly consisting of an average of 50 hours/week. • Full-time work at a minimum of 4 days anytime during a 7-day period. • Approximately 90-95 percent of work performed in vehicle within individual compartments (front and rear). • Exposure to wet and dry conditions, extreme heat and cold, constant vehicle and traffic noise and possibly to gasoline/diesel fumes. Job Schedule Employment Status: Hourly - Full Time Education Requirements Required Preferred X High School:

Responsibilities: • Drive the value of our solution and clearly outline ROI based on the client's objectives. • Grow revenue from existing account base within assigned territory by building strong relationships with clients. • Protect and defend annual revenue, customer base, and subscriptions within defined assignment. • Consult with clients on best practices to increase their ROI. • Liaise with technical support, accounting and other areas of the business to ensure customer satisfaction. • When necessary, conduct customer site visits to grow and retain accounts. • Keep accurate, detailed records of all sales activity in CRM (Salesforce.com). • Responsible for managing the overall account relationship. Works with clients on contract renewals, unit add-ons, additional features and escalated Customer Care issues. • Performs miscellaneous job-related duties as required/assigned. What we're looking for... • Bachelor's Degree in Business or Communications preferred or equivalent business experience • Experience with government contracts or clients preferred • Proficient in Microsoft Office suite • Salesforce.com experience • Entrepreneurial spirit; goal oriented and target driven • Creative and articulate • Strong business acumen and presence; comfortable selling at Executive/Owner level • Ability to work in a fast-paced environment, be accepting of change and multi-task oriented • Strong negotiation skills • Positive, persistent and self-motivated • Exhibits the Verizon Telematics values: Speed, Performance, Accountability, Passion, Teamwork, & Integrity • Minimum travel required • Ability to sit at a desk for the majority of the day VZConnect When you join Verizon... You'll be doing work that matters alongside other talented people, transforming the way people, businesses and things connect with each other. Beyond powering America's fastest and most reliable network, we're leading the way in broadband, cloud and security solutions, Internet of Things and innovating in areas such as, video entertainment. Of course, we will offer you great pay and benefits, but we're about more than that. Verizon is a place where you can craft your own path to greatness. Whether you think in code, words, pictures or numbers, find your future at Verizon.

Amazon Business is a B2B marketplace on Amazon.com that gives businesses of all sizes access to hundreds of millions of products in a shopping experience built for businesses. Amazon Business also serves Government customers that love the convenience of shopping online. However, federal, state and local procurement officials require solutions that fit how public entities operate. The Amazon Business for Government team is dedicated to developing solutions inclusive of an expanded marketplace that combines the selection, convenience, and value customers have come to know and love from Amazon, with new features and unique benefits tailored to customers in the Government sector. Customer Growth Advisors are responsible for supporting long-term strategic customer relationships following an initial on-boarding and stabilization period. The primary areas of responsibility include broadening solution adoption through institution-wide deployment, feature adoption, and developing relationships with buying decision makers across functional areas such as Information Technology, Facilities, and more. Customer Growth Advisors will also support large complex customer engagements requiring additional deployment support. The Customer Growth Advisor will ensure recommended solutions meet our customer's procurement needs and will recommend approaches and alternatives that fit their environment, including but not limited to contracting and competitive requirements unique to public institutions, eProcurement integration, advanced payment, and automated reconciliation processes. The candidate will work closely with customers to manage deployment and ensure that our solutions are successfully adopted. The ideal candidate will have relevant Government consultative sales experience and have a proven track record of meeting and exceeding program goals and revenue targets. Roles and Responsibilities · Strategic Account Management that helps customers design and implement solutions that solve government procurement challenges · Drive and accelerate spend adoption through advising customers on best practices for using Amazon Business solutions · Deliver accurate weekly reporting on growth pipeline and customer spend adoption · Work closely with sales team to provide status updates and insights learned during deployment · Focus on automating as many service needs for customers and work with Product Management and Technical teams to develop solutions that will increase solution adoption · Meet or exceed targets for customer and/or feature spend adoption · Relay market needs and requirements back to internal Amazon teams including Product Management, Technical and Category Management teams - 5+ years sales experience in the Government vertical - BA/BS degree - Experience in identifying, developing, negotiating, and closing large-scale purchasing contracts or software agreements - Experience in positioning and selling innovative solutions to new customers and market segments - Proven track record in identifying and pursuing a large number of accounts over the phone, with ability to close in person - Ability to think and act independently within a fast-paced multi-task driven environment - Experience in proactively growing customer relationships within an account while expanding their understanding of the customer's business - Excellent communications skills with the ability to manage challenging conversations in a professional manner - Deep knowledge of procurement (e.g., Public Sector contracting practices at the State, Local and Federal levels of government) and source to pay processes and solutions · Active listener and effective communicator · Ability to prioritize and demonstrate relentless discipline in achieving goals · Proven ability to influence others and lead customer engagements · Strong ownership, bias for action and willingness to roll up your sleeves · Expert use of MS Office Suite, CRMs (e.g. Salesforce.com) and other systems Amazon is an Equal Opportunity-Affirmative Action Employer - Female/Minority/Disability/Veteran/Gender Identity/Sexual Orientation

Description Perrigo Company plc, a leading global healthcare company, delivers value to its customers and consumers by providing Quality Affordable Healthcare Products®. Founded in 1887 as a packager of home remedies, Perrigo has built a unique business model that is best described as the convergence of a fast-moving consumer goods company, a high-quality pharmaceutical manufacturing organization and a world-class supply chain network. Perrigo is the world's largest manufacturer of over-the-counter ("OTC") healthcare products and supplier of infant formulas for the store brand market. The Company also is a leading provider of branded OTC products throughout Europe and the U.S., as well as a leading producer of "extended topical" prescription drugs. Perrigo, headquartered in Ireland, sells its products primarily in North America and Europe, as well as in other markets, including Australia, Israel and China. Ensure product labeling components are 100% accurate and error free prior to sending to print vendors. Ability to read labeling fine print and to identify differences in text, placement and color when compared to side-by-side copy Must possess exceptional attention to detail skills and accuracy in order to ensure required regulatory compliance standards are met. Demonstrates excellent judgement, planning skills and ability to organize work effectively to meet daily deadlines Must be able to work collaboratively as part of team as well as deliver results working independently Experience Minimum two years of experience in reading, understanding and interpreting regulatory and/or scientific terminology used in the pharmaceutical industry is required. Prior experience in an FDA regulated environment, preferred Prior experience in an auditing position or quality systems position is preferred. Strong oral and written communications skills. We're proud to be an equal opportunity employer- and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status. Different makes us better. Due to the highly regulated pharmaceutical industry and legal requirements, you may be subject to post employment background checks.

Why Rehmann? Since 1941, Rehmann has provided clients proactive ideas and solutions to become one of the top 40 largest accounting/consulting firms in the US. Now, with over 800 associates & 18 offices, we have expanded to form a synergistic collection of services including accounting, wealth management, investigative services, IT and more! Rehmann has earned national recognition including: Top 25 Best Accounting Firms to Work For (Vault.com)#13 in Work/Life Balance#16 in Diversity for Women #20 in Satisfaction 101 Best Companies to Work For in Metro Detroit and West Michigan What makes us one of the best? Real Connections. Real Opportunity. Real Impact. We believe that long term success is built by real connections that foster collaborative relationships with Firm leaders and fellow associates, real opportunities that amplify your talent and leadership potential while maintaining a work/life integration, and real impact that engages your positive influence on not just your Firm and career, but your community and clients too. To learn more about Rehmann, visit: We are seeking a dynamic Audit & Assurance Managerto join our team. In this role, youwill supervise audits for our governmental clients, including cities, villages, townships, counties, public school districts, community mental health authorities, and not-for-profit entities. How You Will Make an Impact at Rehmann: Building relationships internally to foster a culture of teamwork and collaboration Providing a "wow" experience to every client Contributing to the success of our clients' organizations Managing significant and complex audits Researching technical issues encountered during the audit process Presenting audit findings to client leadership Providing direction and new challenges to associates on your team Teaching and developing associates allowing them to reach their goals Mentoring associates as they navigate their career paths Participating in activities to grow the firm and generate business with new clients Identifying opportunities to introduce other Rehmann specialists to existing clients Making a difference in the communities where you live and work Your Desired Skills, Values & Experiences: 5+ years of relevant assurance experience in public accounting or industry CPA license required Outstanding client service and communication skills Ability to manage multiple deadlines in a fast-paced environment Desire to develop unique business solutions in a team-based environment Passion for coaching others to higher levels of performance Enthusiasm for recognizing and rewarding great work by those around you Commitment to continuous learning and development Out-of-the box thinking and an entrepreneurial spirit A new perspective and new ideas allowing us to continuously improve Unwavering integrity in all situations Apply now to begin your Rehmann experience. Real Connections. Real Opportunity. Real Impact.

Job Description POSITION SUMMARY: This position is under the direct supervision of the Shift Manager for assigned shift of the Critical Infrastructure Facility Security Officers (CIFSO) and is responsible for protection of facilities. Officers will enforce regulations to prevent breaches of security while exercising discretion and judgment when responding to situations. ESSENTIAL FUNCTIONS: The functions listed describe the business purpose of this job. Specific duties or tasks may vary and be documented separately. The employee might not be required to perform all functions listed. Additional duties may be assigned, and functions may be modified, according to business necessity. All assigned duties or tasks are deemed to be part of the essential functions, unless such duties or tasks are unrelated to the functions listed, in which case they are deemed to be other (non-essential) functions. Employees are to report hazardous conditions and items in need of repair or attention. In performing functions, duties or tasks, employees are required to know and follow the established schedules. Employees are required to report any deviation from the schedule on the daily activity report. Employees are required to perform all necessary services established by the Use of Force policies to ensure protection and safety. Conduct patrol, including but not limited to in-depth security against trespass, sabotage, theft, vandalism, fire, and other unlawful or harmful acts. Security guards shall conduct visitor center operations including badges, visitor records, and operating x-ray machines as well as metal detectors. Additional duties include conducting inspection tours, monitoring mail packages through Security Control Room, assisting traffic operations, enforce building regulations, respond to emergency management situations, and prepare facilities assessment reports. EQUIPMENT/ COMPUTER SKILLS : Security guards will be responsible for operating all security equipment on post, such as metal detectors, X-ray machines, traffic batons, and have basic typing and computer operations skills. Must demonstrate continuing physical fitness and proficiency with firearms or special weapons on a semi-annual basis. Requirements MINIMUM QUALIFICATIONS: Meet one of the following experience/education requirements: o Prior experience in military (combat arms preferred) o Federal, state, and local law enforcement experience o Three years' experience as armed security guard o Associate's Degree in Security related field Pass the medical examination and CIFSO basic training examination Completed the required training; and pass the required examination(s); LICENSES OR CERTIFICATION: Firearms Qualification and any other certifications (gun permit, expandable police baton, sprays or repellants, HAZMAT Awareness, CPR, AED, First Aid.) WORKING CONDITIONS: With or without reasonable accommodation, requires the physical and mental capacity to perform effectively all essential functions. In addition to other demands, the demands of the job include: Work is performed inside and outside the property with exposure to inclement weather and unpredictable crisis situations. Shift work required. Frequent and prolonged walking, standing, sitting, and stooping, up to 12 hours per day, either indoors or outdoors, during daytime or nighttime.

Description Reach Your Peak with ICMA-RC, a FINANCIAL SERVICES LEADER in public sector employee retirement products and services. Headquartered in Washington, DC, our Financial Services corporation manages over $50 billion in retirement plan assets for more than one million participant accounts. We are constantly looking for ways to create new opportunities to serve our participants. We have an extraordinary talent base and invite you to consider joining ICMA-RC's Compliance Team. This position is responsible for helping to ensure that ICMA-RC's regulated entities operate in compliance with applicable securities laws, rules and regulations of self-regulatory agencies and internal policies and procedures of ICMA-RC. Responsibilities will include assisting in the development, maintenance, oversight and testing of the compliance policy and procedural framework designed to calculate and present performance in compliance with Global Investment Performance Standards ("GIPS") standards. Essential functions for this role include: • Verify whether ICMA-RC has complied with all the composite construction requirements of the GIPS standards ; verify ICMA-RC policies and procedures are designed to calculate and present performance in compliance with the GIPS standards • Responsible for a detailed examination of a specific composite's compliant presentation • Composite construction testing: new; closed; existing; non- discretionary; migrated; and drop out testing • Examination procedures - sample selection; materiality; AUM; attribution; testing the reasonability of market value; accrual of dividend and interest income; contributions and withdrawals; annual vs. benchmark ROR; outlier analysis; overall conclusion analytics (evaluation of client's policies and procedures vs. the GIPS Standards) • Performance measurement calculations - monthly account returns; monthly mutual fund returns; monthly composite returns; annual composite returns; standard deviation; composite and benchmark three (3 )year annualized ex-post standard deviation • Assist in the development, implementation, monitoring and reporting on internal compliance systems and processes designed to reasonably ensure compliance with applicable securities laws and rules of self-regulatory agencies • Under the direction of senior members of the Compliance Department, conduct compliance reviews in regulated entities as necessary to evaluate and test for compliance with applicable rules and regulations, policies and procedures. Provide written reports of findings. • Maintain and update as necessary compliance and supervisory manuals and internal Compliance Department policies and procedures. Keep abreast of changes and new developments in the financial services industry and the impacts these changes have on compliance policies and procedures Requirements If you have the following credentials, we encourage you to apply: • BA/BS or equivalent experience • 5-7 years of prior work experience in an investment company, investment adviser, broker/dealer or other financial services organization. Knowledge and experience with Federal and State securities laws and rules and regulations of self-regulatory organizations • Certificate in Investment Performance Measurement (CIPM) strongly preferred • Knowledge of GIPS standards • Results oriented with the ability to work independently and make sound decisions on the basis of available information • Capable of working effectively with all levels of staff and develop collaborative relationships • Excellent written and oral communications skills • Strong analytical skills and problem solving expertise • Above average Microsoft Excel skills and ability to work with multiple applications • Solid research and interpretive skills For your well-being, we offer a solid compensation and benefits package that features a competitive salary, a straight-forward incentive plan that rewards results, and a 401(k) Plan. For your career, we offer tuition reimbursement, professional development courses, seminars, career enrichment assignments, mentoring programs and a record of enterprise growth that creates continuing opportunities for career advancement. Consider ICMA-RC, and respond in strictest confidence. ICMA-RC is an Equal Opportunity Employer that values diversity in the workplace. Minorities and women are encouraged to apply. We look forward to hearing from you.

CMC/ Regulatory writing experience - 3 + years authoring CMC regulatory documents Scientific background, vaccines preferred Microsoft Office (word, excel, powerpoint) Documentum Applications Trackwise Applications ICH Guidelines GMP experience Experience with drug/biologics licensure Prior regulatory experience

Description Position Purpose: Assist in maintaining Centene Corporation's Compliance Program; guide special projects; provide regulatory interpretation; perform compliance reporting; and develop and implement compliance auditing and monitoring strategies.· Respond to external requests for information required by the organization for its regulatory filings.· Respond to inquiries from state and federal regulatory agencies.· Monitor pending legislation and regulations affecting Centene Corporation services.· Maintain database and other reference materials related to legislative and regulatory issues and compliance.· Communicate state and federal requirements to internal and external clients.· Provide development guidance and assists in the identification, implementation, and maintenance of compliance policies, procedures and work instructions.· Assist in the identification, analysis, and resolution of compliance issues.· Maintain and reviews regulatory documentation necessary to maintain corporate standards.· Assist in developing, producing and conducting compliance training programs.· Perform periodic compliance audits, risk assessments and conducts related ongoing compliance monitoring activities.· Assist health plans in managing relationships with regulatory agencies and seek to resolve policy issues which may negatively impact service to members.· Plan, direct and coordinate the implementation of Compliance Committee policy to ensure decisions are properly executed.· Serve as a companywide resource and liaison on policies, contract issues and provisions, communications, workflow, and quality improvements initiatives.• Performs regulatory filings in SERFF and HIOS Qualifications Education/Experience: Bachelor's degree in related field or equivalent experience. Master's or Juris Doctorate degree preferred and may be considered in lieu of experience. 1+ years of related experience in compliance, privacy and/or regulatory affairs. Working knowledge of laws and/or regulations in area of compliance; in particular HIPAA, and state regulations. Centene is an equal opportunity employer that is committed to diversity, and values the ways in which we are different. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristic protected by applicable law.

Description The Director, Regulatory Affairs - Advertising and Promotion will provide strategic regulatory expertise and guidance to internal stakeholders during the review of advertising, promotional and other related materials for assigned products to ensure compliance with applicable regulations and guidance documents. The individual will represent regulatory on the PRC (Promotional Review Committee) team and must possess a thorough knowledge of regulations for advisement and promotional compliance, governing drugs, device and combination products. Job Responsibilities: Project/Product Regulatory SupportProvide leadership for and manage regulatory aspects of the copy review / approval process for promotional materials, ensure compliance of promotional materials with FDA laws, regulations and published guidance documents.Work closely with R&D project teams to create launch materials for new products and indications. LabelingProvide guidance on proposed claims for products in development and development of ISI (Important Safety Information) and Brief Summaries. Regulatory SubmissionsManage the regulatory aspects of reviewing regulatory submissions and communications with Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP). Oversee timely and accurate submission of promotional materials to OPDP. Sustaining Regulatory SupportContribute to the development and implementation of corporate policies and procedures for regulation of promotional materials and other external communications/press releases.Develop and maintain SOPs and processes for review, approval and submission of advertising and promotional materials to the FDA. Work closely with the Legal, Medical Affairs, and Commercial business units on improving and enhancing the review process, establishing consistent best practices and submission guidelines. Coordinate and implement training of Merz employees on regulatory issues pertaining to promotion of company products. Regulatory IntelligenceRegularly monitor the regulatory compliance trends in the industry, interpret new regulations, guidance documents and enforcement actions. Advise internal stakeholders on relevant new and existing regulatory risk and compliance requirements and provide regulatory expertise, advice, and support to Sales and Marketing and other product-related teams. Qualifications and Skills: Bachelor's Degree in scientific or health discipline is required. An M.S. or higher is preferred. A minimum of 10 years of pharmaceutical industry experience and 5 years as a regulatory affairs reviewer of advertising and promotional materials is required. Direct experience with development, preparation and submission of advertising and promotional materials. Strong knowledge of US regulatory environment and FDA regulations and guidance regarding advertising and promotional materials for Cosmetics, Drugs, and Medical Devices. Must have a proven track record interacting with OPDP. Proficient in all MS Office applications. Demonstrated organizational skills, ability to independently prioritize work and detail oriented. Hands on Experience with preparation of OPDP submissions, including preparation of electronic submissions. Strong verbal and written communication skills. Demonstrated leadership skills and experience leading a team. Excellent interpersonal and communication skills. Excellent conflict resolution skills. Education Required Experience Required

Description: Develops CMC regulatory strategy and provides Regulatory advice outside of Regulatory Affairs. Reviews and approves Regulatory and Quality documents. Uses technical and scientific knowledge to conduct the appropriate analysis of CMC submission documentation. Responsible for the development and preparation of CMC documentation for submission to local and global regulatory competent authorities Responsible for timely and accurate tracking and management of regulatory authority requests. Reports or communicates status of product / project status to respective GRT and CMC local head. Performs change control assessments and manages assigned action items. Assembles information, organize, and write technical CMC section parts of dossiers. Assesses source information to provide needed risk assessments. Anticipates delays in pre-defined submissions and either sets up corrective actions plan or proposes alternative solutions. Communicates variation status to Industrial Affairs. Requests STN and Serial Numbers from health authorities. Participate and provide support in inspection preparation and inspection as requested. Manages contacts with regulatory agencies or third parties, relevant function within IA, and project teams. Sets up necessary meetings among all parties, and discusses and potentially negotiates issues among parties. Provides input and resources towards the development and implementation of new RA systems, procedures, and/or tools. Responsible for staying up-to-date on regulatory guidances and technical / scientific developments. Qualifications: Basic Qualifications: Bachelor's or Master's degree in a scientific field (Biology or Life Sciences is preferred). Minimum of 2 years of Regulatory Affairs with CMC experience in Industry. Preferred Qualifications: Demonstrated knowledge in microbiology, immunology, virology, or bacteriology. A minimum of 1 year of prior Manufacturing or Quality Assurance experience in the pharmaceutical / biotech industry. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Job Description: • Driving automatic and/or standard shift vehicles from 8,000 to 36,000 pounds gvw a minimum of 4 hours per day, 5 days per week, in accordance with a designated route, making stops at a minimum of 30 customer locations. • Servicing ATM machines on a set schedule, including re-supplying replenishing, retrieving deposits, and monetarily balancing the machine. • Picking up/delivering customer change orders/deposits carrying a minimum of 50 pounds by hand or up to several hundred pounds by cart, a minimum of 30 stops per day for a minimum of 4-5 hours, 5 days per week. • Loading/unloading vehicle cargo consisting of multiple bags and boxes of coins, weighing as much as 50 pounds per item, 5-6 days per week. • Counting items, recording amounts and serial numbers, signing and dating receipts and manifests, sorting individual cargo items by route. • Communicating with customers verbally on-site and via telephone and two-way radio to report emergencies and approach to Loomis, Fargo and Company facility. • And other duties assigned. Skills / Qualifications Required: PERFORMANCE REQUIREMENTS: • Ability to repeatedly perform heavy lifting and carrying items by hand in an unrestricted manner for significant distances (several yards). • Ability to push/pull dollies/carts loaded with cargo weighing up to several hundred pounds. • Unrestricted ability to bend, stoop, squat, stand, walk, climb, twist, turn and reach out. • Ability to operate a motor vehicle safely in accordance with Driver Physical Qualifications established by the US Department of Transportation, Federal Highway Administration. • Ability to read and speak the English language sufficiently to converse with general public, to understand highway traffic signs and signals in the English language, to respond to official inquires, and to make entries on reports and records. • Ability to sign and record numbers by hand. • Ability to count, record, add, subtract, and balance columns of numbers. • Ability to operate large automatic shift vehicles. • Ability to meet state requirements for handgun license/permit or Security Officer Commission. • Good attendance and punctuality. • Ability to interact constantly with co-workers, customers, and the general public. • Ability to handle change in sequence and routine on short notice. WORKING CONDITIONS: • Full-time schedule possibly consisting of an average of 50 hours/week. • Full-time work at a minimum of 5 days anytime during a 7-day period. • Approximately 90-95 percent of work performed in vehicle within individual compartments (front and rear). • Exposure to wet and dry conditions, extreme heat and cold, constant vehicle and traffic noise and possibly to gasoline/diesel fumes. Job Schedule Employment Status: Salary - Full Time Work Schedule: Monday: 9:00 a.m. - 5:00 p.m. Monday Tuesday: 9:00 a.m. - 5:00 p.m. Tuesday Wednesday: 9:00 a.m. - 5:00 p.m. Wednesday Thursday: 9:00 a.m. - 5:00 p.m. Thursday Friday: 9:00 a.m. - 5:00 p.m. Friday

Why Qualtrics? At Qualtrics, our mission is to close experience gaps-the costly differences between what customers and employees expect, and what they're receiving. 9,000+ organizations worldwide and more than 80% of the Fortune 100 rely on the Qualtrics Experience Management Platform™ to collect, analyze, and act on feedback-more feedback than they ever thought possible. With Qualtrics XM, organizations can manage the four core experiences of business-customer, employee, product, and brand experience. Organizations can be at every meaningful touchpoint, for every experience, and predict what will resonate most with customers and employees. Primary Responsibilities Attract, engage, develop, and retain a high-performing team of sales professionals and leaders passionate about building a business in the SLG Sector Provide skill development and mentorship on key enterprise motions including pipeline development, prioritizing resources, creating local contracting relationships, collaboration with legal, product presentations, leading multiple internal teams and quarterly sales forecasting Ensure team members maintain accurate and complete records of the opportunities and pipeline as well as forecast the business on a regular basis Serve as executive sponsor during enterprise level deals Interface and develop professional relationships with existing clients and prospects throughout the organizational levels Build working relationships with license, consulting and education field managers in the respective territory to develop joint account plans Display a systemic approach to managing meaningful contract negotiations/deals with multiple reps at a time Maintain a real-time understanding of the competitive landscape to assist in determining win-based proposals and pricing Qualifications Minimum 5 years managing a high-growth software sales team 15 years of experience selling SaaS solutions to Public Sector accounts Successful track record leading sales teams in achieving assigned targets Successful track record providing executive-level impact to government clients and partners Ability to learn and understand product solutions and features with excellent verbal and written communication skills Ability to understand customer's industry and core business processes Strong quantitative, analytical and conflict resolution abilities Experience using MEDDIC sales processes Experience using Salesforce.com and measuring system compliance Bachelor's degree or higher is required About the Team Our team is a group of highly driven individuals that are intelligent, organized, and dedicated. We work together as a team to accomplish and exceed quarterly and annual objectives. We are an ambitious team that works hard and enjoys the incredible trajectory that Qualtrics provides. Our overarching objective is to drive company revenue growth through client success. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.