Medical writer and Regulatory Affairs associate
Primary function of the position
Clinical scientific knowledge and writing skills to effectively and clearly communicate medical science information in writing. Generally, focus on either scientific medical writing, which includes clinical studies, and regulatory documents, scientific articles or marketing medical writing. Experience in regulatory aspects (RA), help to lead regulatory strategy and provide ongoing regulatory input.
Roles and Responsibilities
- Work with clinical teams and clients to understand the nature of the scientific work that they will be covering.
- Assess data or products using medical expertise, and quickly develop expertise in new areas as needed for their writing.
- Help to write studies for submissions to the FDA. The writing is also used in publications or medical journals, or for internal company use.
- Comprehensive writing of clinical study reports, study protocols, annual reports, investigator brochures, risk/benefit analysis and integrated summaries from raw data.
- Prepare abstracts, scientific exhibits, posters and verbal presentations.
- Help with develop and write pharmaceutical training materials, eLearning content, video scripts, magazine articles, and presentations to be used by a variety of audiences.
- Conduct comprehensive literature searches to enhance background understanding, and evaluate and analyze the information which will be written about.
- Provide responses to regulatory agencies regarding product information or issues.
- Maintain current knowledge of relevant regulations, including proposed and final rules. Help in manage activities such as audits, regulatory agency inspections etc.
- Participate in the development or implementation of clinical trial protocols. Preparation and submission of regulatory agency applications, reports, or correspondence.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- At least 2 years’ relevant experience in a bio/pharma/CRO
- A Bachelor’s degree in Biological Sciences, Biochemistry, Chemistry, Toxicology, Pharmacy, Medicine, Engineering, or Pharmacology.