Senior AD, Scientific Affairs, Medical Information, Medical Review

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $165.6k - $294k / year

⏰ Full Time

🟠 Senior

🏆 Customer Success

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Boehringer Ingelheim

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🏭 Manufacturing

💊 Pharmaceuticals

Healthcare • Manufacturing • Pharmaceuticals

Boehringer Ingelheim is a global, research-driven, family-owned pharmaceutical company headquartered in Germany that discovers, develops, manufactures, and markets prescription medicines, biopharmaceuticals, vaccines, and animal health products. The company focuses on therapeutic areas including respiratory, cardiovascular, metabolic, oncology, immunology, and zoonotic diseases, and invests heavily in R&D and biotechnology to advance drug discovery and development. It operates worldwide across both human pharmaceuticals and animal health markets, partnering with academic institutions and biotech firms to translate scientific research into therapies.

📋 Description

• Develop, maintain, and continuously improve U.S. Medical Information assets • Serve as Medical Reviewer on the Human Pharma Review Committee • Support MLR review of U.S. medical and promotional communications • Partner with Medical Affairs Strategy and Global Medical Information to deliver accurate, scientifically balanced, globally aligned content • Plan and prioritize Medical Information response content using customer inquiries, emerging evidence, and external trends • Provide actionable insights for cross-functional medical and business strategies • Advise project owners on material feasibility and provide solution-oriented guidance for HPRC submissions • Develop and review Medical Information content, including FAQs, SSRCs, customized responses, dossiers, and training resources • Collaborate with Global Medical Information, Medical Affairs, Regulatory Affairs, Patient Safety & Pharmacovigilance, and externally facing functions • Maintain documentation of review activities, track changes, and provide stakeholder feedback • Provide medical training and support to contact center and internal stakeholders • Review promotional and non-promotional materials for accuracy, clarity, and compliance • Verify 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 comprehensive knowledge of product information, clinical data, medical advancements, regulatory guidelines, and industry best practices • Perform business in accordance with FDA regulations, PhRMA Guidelines, and company policies • Build internal awareness of the Medical Information and Medical Review group • Support vendor training, quality, training, innovation, and department core functions • SAD: Provide leadership and advanced Medical Information and Medical Review expertise • SAD: Drive continuous process and system improvement based on evolving customer needs • May participate in external activities such as DIA and PhactMI

🎯 Requirements

• Advanced Degree Related to Healthcare focus (e.g., PharmD, NP/PA, MD, PhD) from an accredited institution • AD: Minimum of two (2) years of experience in a clinical practice environment, including Residency training • AD: Three-plus (3+) years of industry experience, preferably with experience in development and/or medical affairs • AD: At least three to five (3-5) years pharmaceutical industry experience or completion of a two-year Boehringer Fellowship program in MI or equivalent • SAD: Minimum of two (2) years of experience in a clinical practice environment, including Residency training, and three-plus (3+) years of industry experience • SAD: At least seven (7) years pharmaceutical industry experience in MI 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 with U.S. Medical Information practice • Experience supervising staff across medical information and third-party vendors • Ability to ensure compliance with SOPs, policies, and work instructions • Demonstrated customer focus, customer satisfaction, and continuous process/asset improvement • Ability to work cross-functionally at franchise and enterprise levels • Flexibility working with internal and external stakeholders • Highly developed ability to influence and work effectively through others • Business acumen and judgment balancing scientific standards with business relevance and impact • Excellent communication skills • Must be legally authorized to work in the United States without restriction • Must be willing to take a drug test and post-offer physical, if required • Must be 18 years of age or older

🏖️ Benefits

• Competitive compensation and benefit programs • Healthy working environment • Meaningful work • Mobility opportunities • Networking opportunities • Work-life balance • Role-specific variable or performance-based bonus may be available • Other compensation elements may be available