Sr Manager, Medical and Scientific Affairs

ANI Pharmaceuticals•Princeton, NJ

1d•$150,000 - $200,000

About The Position

We are a publicly traded pharmaceuticals company committed to improving patient outcomes through the development, manufacturing, and commercialization of innovative therapies. Our Legal and Compliance team is a strategic partner to the business, supporting a dynamic portfolio of branded, generic, and specialty pharmaceutical products. We foster a culture built on integrity, collaboration, and a shared sense of purpose. At ANI Pharmaceuticals, there are opportunities to contribute to our purpose every day. We value authenticity, knowledge, and hard work, we strive to celebrate our employees in a positive environment. Our culture empowers everyone to be successful and apply our full potential. The Senior Manager, Medical & Scientific Affairs supports the medical and scientific strategy for the rare disease portfolio, with expanded focus across Medical Information, Publication Planning, Medical and Scientific Communications, and Medical Material Review. This role is responsible for the development, review, review, and dissemination of accurate, compliant, and impactful scientific content to healthcare professionals, patients, and internal stakeholders. The role requires deep subject matter expertise, cross-functional collaboration, and the ability to navigate the complexities of rare disease education and communication.

Requirements

Advanced scientific/clinical degree required (PharmD, PhD, MD, or equivalent).
3-5 years experience in Medical Affairs, Medical Information, Medical Communications, Publication Planning and/or related functions within the pharmaceutical or biotech industry (rare disease experience strongly preferred).
Deep understanding of regulatory and compliance requirements for Medical Information medical content and scientific communications.
Experience with medical information systems, inquiry management databases, and/or publications/communications deliverables.

Nice To Haves

Scientific and clinical expertise with the ability to interpret and communicate complex data.
Strategic and analytical thinking
Cross-functional leadership and collaboration
Attention to detail and commitment to compliance
Strong project management skills
Ability to develop high-quality scientific content and delivering impactful medical information services.
Demonstrated ability to synthesize complex scientific data into clear, concise, and balanced communications.
Excellent written and verbal communication skills; strong interpersonal and collaboration abilities.
Ability to thrive in a fast-paced, evolving rare disease environment with a high degree of autonomy and accountability.

Responsibilities

Develop, review, and maintain a comprehensive library of standard response documents (SRDs), FAQs, and scientific content for medical information inquiries.
Ensure all materials are scientifically accurate, balanced, referenced, and compliant with applicable regulatory and industry standards (e.g., PhRMA, FDA, EMA).
Provide high-quality, timely, and consistent responses to unsolicited medical inquiries from healthcare professionals, patients/caregivers, and internal stakeholders.
Monitor and assess trends in inquiries to identify emerging data needs, knowledge gaps, or potential safety signals.
Partner with Medical Affairs colleagues to ensure alignment of medical information strategies with broader medical and scientific objectives.
Collaborate with Legal, Regulatory, and Compliance to ensure all materials and activities adhere to company standards and policies.
Support the development and review of scientific publications, congress materials, and educational resources as needed.
Oversee the Medical Information request intake, tracking, and reporting system, ensuring compliance with SOPs and regulatory requirements.
Develop and implement processes to ensure consistency, efficiency, and quality of medical information services. Partner with vendors, agencies, and external contributors supporting publications, communications, and medical information deliverables.
Contribute to the development of metrics and KPIs to assess the effectiveness of medical information deliverables and continuously improve processes.
Contribute to the development and execution of publication strategies and plans that support scientific communication goals across the product life cycle, including manuscripts, abstracts, posters, and congress deliverables according to industry standards (e.g., Good Publication Practice, ICMJE).
Support the drafting, reviewing, and coordination of scientific publications and congress materials to ensure clarity, accuracy, and compliance with journal and regulatory guidelines.
Support the development, review, and refine scientific communications and educational materials for external and internal audiences, including slide decks, medical narratives, scientific summaries, and disease state backgrounders.
Support medical congress planning and scientific exchange activities, including presentation development and post-meeting summaries.