Job Summary The Medical Writer, Medical Information is responsible for developing accurate, balanced, and compliant medical responses to unsolicited requests regarding disease state, product information, and off-label use for internal and external customers. The role supports Medical Information (MI) operations by researching, drafting, updating, and maintaining approved standard and custom responses using product labeling, published literature, and data on file.
This position manages materials from draft through approval and contributes to the maintenance of the Medical Information library. The Medical Writer works collaboratively with cross-functional partners and vendors while adhering to established Medical Information standards, SOPs, and applicable legal and regulatory guidelines. The role is an individual contributor position focused on high-quality execution and skill development within Medical Information.
Key Responsibilities- Develops and maintains standard and custom Medical Information responses (e.g., MI letters, FAQs) to unsolicited requests related to disease state, product information, and off-label use in accordance with approved labeling, literature, and data on file.
- Conducts literature searches and evaluates scientific and clinical data to support accurate, balanced, and compliant medical responses.
- Updates existing Medical Information materials to incorporate newly published literature and approved data as directed by business needs and SOPs.
- Supports maintenance of the Medical Information library by ensuring approved content is current, accurate, and available for appropriate use; assists colleagues with awareness and access to materials.
- Reviews vendor-generated Medical Information case documentation and provides timely feedback to ensure alignment with SOPs and quality standards.
- Participates in Medical Information training activities by supporting development and delivery of content-based training (e.g., product, disease state, templates, and processes) for vendors and internal partners.
- Operates in compliance with applicable Medical Information governance, SOPs, and regulatory requirements, including FDA, GCP, PhRMA, OIG, HIPAA, and other relevant guidelines.
- Collaborates with cross-functional partners (e.g., Medical Affairs, Pharmacovigilance, Regulatory, Quality, Commercial) to ensure consistent and compliant medical responses.
- Contributes to continuous improvement efforts by identifying opportunities to enhance content quality, efficiency, and process adherence.
Skills & Qualifications- Bachelor's degree required; advanced degree in a scientific or healthcare-related field preferred.
- Licensed healthcare professional (e.g., PharmD, PhD, RN, NP, PA) preferred but not required.
- 2-5 years of experience in medical writing, Medical Information, Medical Affairs, clinical development, or a medical communications agency.
- Experience supporting Medical Information content development and response management preferred.
- Familiarity with Medical Information or content management systems (e.g., IRMS, LifeSphere Medical Affairs, Veeva MedComms/PromoMats) preferred.
- Working knowledge of Medical Information compliance requirements and relevant regulations, including FDA, GCP, PhRMA, OIG, HIPAA, and related guidance.
- Understanding of clinical trial design and basic biostatistics and their application to interpretation of clinical data.
- Strong scientific and analytical skills with the ability to critically evaluate medical literature and data.
- Strong written communication skills, with demonstrated experience in scientific or medical writing and familiarity with AMA Style.
- Proficiency in scientific literature databases (e.g., PubMed, MEDLINE, EMBASE, Copyright Clearance Center).
- Ability to manage multiple tasks, organize work effectively, and meet timelines in a fast-paced environment.
- Effective verbal communication skills and ability to work collaboratively within cross-functional and vendor-supported environments.
- Demonstrates professionalism, integrity, attention to detail, and a commitment to compliant behavior.
What we offer in returnYou will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base. You will also have access to a range of company benefits, including a competitive wage with shift differential, annual bonus opportunities and career advancement and cross-training.
Next Steps- If your profile is a match, we will invite you for a first virtual conversation with the recruiter.
- The next step is a virtual conversation with the hiring manager
- The final step is a panel conversation with the extended team
