Proclinical is seeking a remote Principal Medical Writer for a top pharmaceutical company.
Must be eligible to work or be a citizen in the US.
- Provide medical writing expertise for multiple compounds/devices and/or projects within various therapeutic areas (oncology and aesthetics highly preferred, immunology preferred).
- Serve as the medical writing lead on more complex clinical regulatory documents, such as those associated with filings and dossiers.
- Serve as a subject matter expert within department for the Aesthetics area.
- As assigned, provide direction and guidance to medical writers regarding assigned projects, including review of work product.
- Provide input and feedback to management regarding internal medical writers’ work product/quality.
- Convert relevant data and information into a form that meets clinical regulatory document requirements.
- Must identify and resolve conflicts (including document content issues), remove barriers, generate innovative ways to ensure teams achieve project goals.
- Perform literature searches as needed for drafting document content. Interprets literature information and makes recommendations for application to clinical regulatory documents.
- Maintain expert knowledge of US and international regulations, requirements, and guidance associated with clinical regulatory document preparation and submissions.
- Coach, mentor, and assist medical writers.
Skills And Requirements
- Bachelor of Science required, with significant relevant writing experience, or Bachelor’s degree in English or communications, with significant relevant science experience.
- Masters or PhD in science discipline preferred with relevant writing experience.
- 10+ years in clinical writing – items like protocols, CSRs, IB, CSURs, submission docs (CO, RMP, CSE, CSS)
- American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.
- Expert in word processing, flow diagrams, and spreadsheets
- Expert knowledge of current electronic document management systems and information technology.
- Knowledge of Medical Device Regulation (MDR) preferred.
If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at (+1) 215– 531– 6914 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.
Proclinical Staffing is an equal opportunity employer.
<!– – AI CONTENT END 1 – – >