Manager, Medical Review, Medical Affairs

Job Description

Our Waltham based pharmaceutical client is seeking a Manager, Medical Review, Medical Affairs to join their growing team. The incumbent will be responsible for providing the medical and scientific accuracy review of promotional and non-promotional materials across the portfolio. As necessary, this individual may support broader activities within Medical Affairs. The employee carries out this role in accordance with departmental SOPs, corporate policy, and other legal and regulatory requirements.

Key Responsibilities

• Ensure medical accuracy of Company’s advertising, promotional and scientific materials as part of Promotional Material Review Committee (PMRC) and Medical Material Review Committee (MMRC), in collaboration with the Medical Information Lead and Medical Directors
• Responsible for fact-checking of data points and verifying that all claims and statements are adequately supported by appropriate references and properly cited in materials submitted to the PMRC/MMRC
• Partner with cross-functional PMRC/MMRC team to ensure compliance with regulatory, compliance and corporate standards in all materials
• Attend and participate in cross-functional PMRC and MMRC meetings
• Perform reviews in a timely manner by the requested due date
• Provides support to Medical Communications initiatives as needed

Qualifications

• Bachelor of Science degree in relevant scientific or medical field required. Advanced degree (Master’s or Doctorate) preferred
• 1- 3 years of experience in pharmaceutical/biotech industry-based medical information/medical review or related discipline
• Excellent written, verbal, and interpersonal communication skills
• Must be a strong team player with the ability to effectively collaborate with cross-functional team
• Superior literature database search skills
• Proficiency with Microsoft Office suite
• Detailed-oriented with strong ability to work independently
• Excellent organizational, time management, and prioritization skills
• Prior experience working with promotional/medical review systems (e.g., Veeva PromoMats)
• Adept at learning new software / applications
• Prior experience in rare disease, oncology, or related therapeutic area is preferred

About Stratacuity:

• Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.

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• Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

• Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.

• Everforth Apex

Benefits

• Overview: Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our ‘Welcome Packet’ as well, which an Everforth Apex team member can provide.

• Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.

• If you require an accommodation under the Americans with Disabilities Act to participate in an interview with a virtual recruiter or to use our website for a search or application, please contact our

Benefits

• Department at accommodations. Please note that this contact information is strictly to be used for medical ADA accommodations and that no other inquiries will be answered.

• UnitedHealthcare creates and publishes the Transparency in Coverage Machine-Readable Files on behalf of Everforth Apex Systems.