Medical Writer

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 MI standards, SOPs, and applicable legal and regulatory guidelines.
Key Responsibilities

Develop and maintain standard and custom Medical Information responses (e.g., MI letters, FAQs) in accordance with approved labeling, literature, and data on file.
Conduct literature searches and evaluate scientific and clinical data to support accurate, balanced, and compliant medical responses.
Update existing Medical Information materials to incorporate newly published literature and approved data as directed by business needs and SOPs.
Maintain the Medical Information library, ensuring approved content is current, accurate, and available for appropriate use; assist colleagues with access to materials.
Review vendor‑generated Medical Information case documentation and provide timely feedback to ensure alignment with SOPs and quality standards.
Participate in Medical Information training activities by supporting the development and delivery of content‑based training (e.g., product, disease state, templates, and processes) for vendors and internal partners.
Operate in compliance with applicable Medical Information governance, SOPs, and regulatory requirements, including FDA, GCP, PhRMA, OIG, HIPAA, and other relevant guidelines.
Collaborate with cross‑functional partners (e.g., Medical Affairs, Pharmacovigilance, Regulatory, Quality, Commercial) to ensure consistent and compliant medical responses.
Contribute 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

The company embraces diversity & inclusion and offers competitive wage with shift differential, annual bonus opportunities, and career advancement and cross‑training. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
Equal Opportunity

Galderma offers equal employment opportunities to all employees and applicants without regard to race, color, religion, national origin, gender or gender identity, sexual orientation, age, disability, or veteran status.

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