
Medical Information Manager
Posted 2 days ago

Posted 2 days ago
This is a fully remote position, open to applicants in North Carolina.
• Address verbal and written medical inquiries from both internal and external stakeholders regarding post-launch products.
• Create medical information letters, dossiers, documents, and presentations.
• Distribute precise, balanced scientific and medical information.
• Assist in the capture and reporting of adverse events and product complaints while ensuring compliance.
• Develop and revise data-driven responses to customer inquiries.
• Relay information promptly to both internal and external customers.
• Collaborate with teams in Pharmacovigilance, Quality, Field Medical, Medical Affairs, Regulatory, Marketing, and Commercial sectors.
• Proofread and edit medical content for grammatical precision, clarity, and consistency.
• Review medical and promotional content via the Medical, Legal, and Regulatory process in Veeva systems.
• Conduct medical accuracy reviews of promotional materials.
• Ensure that content adheres to regulatory and company standards.
• Track reviewer feedback and implement necessary revisions.
• Develop, organize, and maintain repositories of standard medical responses, FAQs, and reference materials.
• Update resources in response to new evidence, product updates, and regulatory guidance.
• Provide approved medical content to Medical Affairs and cross-functional teams.
• Monitor key publications and share concise scientific summaries.
• Ensure that communications comply with regulatory requirements and ethical standards.
• Stay updated on industry guidelines and best practices.
• Offer off-hours support for urgent medical inquiries.
• Represent Medical Affairs at scientific congresses through booth engagements.
• Manage the RightFind copyright clearinghouse and EndNote publication library.
• Doctor of Pharmacy (PharmD) with an active pharmacy license, or completion of a Residency or Fellowship in Medical Information.
• A minimum of 3-5 years of experience in the pharmaceutical industry or medical information.
• Proficiency in abstracting databases (Embase and PubMed) for literature searches and full-text document retrieval.
• Capability to manage multiple projects, prioritize effectively, and deliver results under tight deadlines.
• Knowledge of regulations and guidelines concerning Medical Information and Medical Affairs.
• Strong writing and editing skills for medical response letters, scientific summaries, and content directed at healthcare professionals (HCP).
• Familiarity with the Medical, Legal, and Regulatory review process and standards for promotional and scientific materials.
• Ability to collaborate effectively across Medical Affairs, Regulatory, Marketing, and Commercial teams.
• Strong influencing, facilitation, and presentation skills.
• Ability to act as a medical information subject matter expert for both internal and external audiences.
• Self-motivated with a desire to learn new skills.
• Proven ability to work cross-functionally.
• Up to 15% domestic travel is required.
• Preferred: At least 1 year of medical writing experience.
• Preferred: Active participation in accredited medical writing associations is advantageous.
• Preferred: Experience with IRMS or Veeva MI as a user and administrator, or the technical ability to learn quickly.
• Preferred: Experience with publication review.
• Preferred: Clinical experience in pulmonary hypertension.
• Competitive compensation package.
• Medical insurance.
• Dental insurance.
• Vision insurance.
• Short-term disability (STD).
• Long-term disability (LTD).
• 401(k) Savings Retirement Plan.
• Employee Stock Purchase Plan (ESPP).
• Reasonable accommodation for qualified individuals with disabilities.
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