Summary of Role
The Senior Medical Writer researches, creates, and edits all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects; working with other PAREXEL departments and clients to set and meet internal and external deliverable timelines; leadership, training and support of junior medical writing staff. REGULATORY WRITING EXPERIENCE WOULD BE THE BEST MATCH.
Specific Responsibilities include:
'' Write clinical documents for submission to North American and European regulatory authorities, including but not limited to: briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, clinical overviews and summaries, expert reports, safety updates, integrated summaries of safety and efficacy.
'' Prepare other clinical documents such as study manuals, monitoring guidelines, position papers and manuscripts.
'' Manage medical writing
projects, to include serving as the primary client contact, negotiating
deliverable timelines, and resolving project-related issues.
'' Serve as the Medical Writing
representative on assigned project teams, providing support to Project
Management.
'' Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.
'' Ensure document content and style adheres to FDA/EMEA or other appropriate regulatory guidelines, and complies with departmental and corporate or client SOPs and style guidelines.
'' Coordinate and conduct
interdivisional team review and sign-off of document deliverables according to
PAREXEL guidelines/SOPs including.
'' Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
'' Review statistical analysis plans to assist in determining appropriateness of content/format for clinical writing.
'' Provide training and
guidance and act as a mentor to less experienced departmental members.
'' Initiate and participate in departmental or interdivisional process improvement and training initiatives.
This position can be based in the Durham, NC or Waltham, MA office, or can be home-based.