It is the Medical Writer's role to oversee all report writing activities for the projects he/she is supporting. The Medical Writer must ensure consistency across documents and improve overall document quality. It is the Medical Writer's responsibility to provide the appropriate background information, guidance, and training to any writer producing documents to support their tasks.
The Medical Writer will prepare and/or review all final documents (i.e., protocols/analysis plans/reports/Investigator Brochures/submission pieces).
Essential Duties and Responsibilities:
· Build and maintain knowledge base to improve the overall medical content of documents.
· Write and/or review clinical and non-clinical study reports and regulatory submission documents, including ISE, ISS, Clinical and Non-Clinical section of an NDA, etc.
· Write and/or review protocols, amendments, review statistical analysis plans. Ensure appropriate incorporation into reports.
· Drive the clinical study report writing process by conducting or ensuring the following activities have been accomplished:
o Identify report contributors and their responsibilities.
o Develop and maintain timelines.
o Ensure that all possible report activities are completed prior to database lock.
o Review primary statistical output and participate in results review meetings.
o Lead discussions on report finalization.
· Prepare reports, manage review cycles, and incorporate comments as appropriate.
· Manage compilation of report appendices.
· Prepare, review and edit publications.
· Work effectively with other staff members in team situations, as well as external vendors.
· Other duties as assigned.