Senior AD, Scientific Affairs, Medical Information, Medical Review

This is a fully remote position, open to applicants in United States.

📋 Description

• Develop, maintain, and enhance U.S. Medical Information assets.

• Act as Medical Reviewer on the Human Pharma Review Committee.

• Assist in MLR review of U.S. medical and promotional communications.

• Collaborate with Medical Affairs Strategy and Global Medical Information to produce precise, scientifically balanced, and globally aligned content.

• Organize and prioritize Medical Information response content based on customer inquiries, emerging evidence, and external trends.

• Provide actionable insights for cross-functional medical and business strategies.

• Advise project owners on the feasibility of materials and offer solution-oriented guidance for HPRC submissions.

• Create and review Medical Information content, including FAQs, SSRCs, tailored responses, dossiers, and training resources.

• Work alongside Global Medical Information, Medical Affairs, Regulatory Affairs, Patient Safety & Pharmacovigilance, and external functions.

• Document review activities, track modifications, and provide feedback to stakeholders.

• Deliver medical training and support to contact center and internal stakeholders.

• Evaluate promotional and non-promotional materials for accuracy, clarity, and compliance.

• Ensure data integrity and interpretation against clinical evidence, product information, disease-state knowledge, regulations, and internal standards.

• Collaborate with medical affairs strategy, marketing, sales, legal, regulatory affairs, and operations.

• Maintain extensive knowledge of product information, clinical data, medical advancements, regulatory guidelines, and industry best practices.

• Conduct business in accordance with FDA regulations, PhRMA Guidelines, and company policies.

• Raise internal awareness of the Medical Information and Medical Review group.

• Support vendor training, quality, innovation, and core departmental functions.

• SAD: Provide leadership and advanced expertise in Medical Information and Medical Review.

• SAD: Propel continuous process and system enhancements based on evolving customer needs.

• May engage in external activities such as DIA and PhactMI.

⛳️ Requirements

• Advanced Degree in a Healthcare-related field (e.g., PharmD, NP/PA, MD, PhD) from an accredited institution.

• AD: Minimum of two (2) years of experience in a clinical practice setting, including residency training.

• AD: Over three (3+) years of industry experience, preferably with a background in development and/or medical affairs.

• AD: At least three to five (3-5) years of pharmaceutical industry experience or completion of a two-year Boehringer Fellowship program in Medical Information or equivalent.

• SAD: Minimum of two (2) years of experience in a clinical practice environment, including residency training, plus over three (3+) years of industry experience.

• SAD: A minimum of seven (7) years of pharmaceutical industry experience in Medical Information or equivalent.

• Clinical knowledge of assigned therapeutic areas.

• Understanding of the clinical development process, medical affairs functions, product commercialization, pharmaceutical regulations, and regulatory requirements.

• Knowledge and experience in U.S. Medical Information practices.

• Experience supervising staff in medical information and third-party vendors.

• Ability to ensure compliance with SOPs, policies, and work instructions.

• Proven customer focus, satisfaction, and continuous process/asset improvement.

• Capability to work cross-functionally at both franchise and enterprise levels.

• Flexibility when collaborating with internal and external stakeholders.

• Highly developed ability to influence and work effectively through others.

• Strong business acumen and judgment in balancing scientific standards with business relevance and impact.

• Excellent communication skills.

• Must be legally authorized to work in the United States without restrictions.

• Must be willing to undergo a drug test and post-offer physical, if required.

• Must be 18 years of age or older.

🏝️ Benefits

• Competitive compensation and benefits programs.

• Healthy working environment.

• Meaningful work.

• Mobility opportunities.

• Networking opportunities.

• Work-life balance.

• Role-specific variable or performance-based bonus may be available.

• Additional compensation elements may be available.