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.
Requirements
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
Benefits
Health insurance
Additional Information
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
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.
Galderma · Fort Worth