Yacht Life Sciences has a vacancy for a Senior Medical Writer who is interested to become a Medical Writing Document Manager Oncology. For the Medical Writing team of our client, we are looking for a Senior Medical Writer who is located with the EU and is willing to work from home.

The responsibilities of the Senior Medical Writer include, but are not limited to the following:

• Works independently to write and edit clinical study reports, Investigator’s Brochures, Clinical Trial Results postings, annual reports, and other clinical regulatory documents across multiple therapeutic areas as assigned. Works with contract writers as needed for the timely delivery of assigned documents.
• Reviews clinical protocols, Statistical Analysis Plans, Statistical Programming Plans, data tables and listings, and other clinical regulatory documents as needed.
• Leads the preparation of briefing documents, INDs, licensing submissions (BLAs, MAAs), and other complex clinical regulatory documents as needed.
• Negotiates timeline development for preparation of clinical regulatory documents.
• Demonstrates critical thinking in the analysis and presentation of clinical study data.
• Leads the process of critical review of clinical regulatory documents and incorporates multiple reviews into successive drafts.
• Provides QC support for clinical regulatory documents as needed (cross-checking data and verifying content from source documents).
• Reviews case report forms, statistical analysis plans, and data tables and listings for content and format.
• Assists with or leads the preparation or revision of SOPs, WPDs, and document templates. Assists with training across functional areas for the implementation of new/revised procedures and templates.
• Participates in clinical project team meetings.
• Participates in or leads other cross-functional team meetings and standards committees.
• Ensures the quality of clinical regulatory documents by maintaining and promoting familiarity with ICH, GCP, and other standards.

Once you become a Document Manager, you:

• Act as head of a document working group for multi-component projects with strategic aspects (e.g., marketing applications, Investigational New Drug (IND) applications, responses to regulatory authorities, etc.).
• Coordinate, manage and facilitate the tasks necessary for document drafting, review and completion within a document working group. This may include drafting timelines, requesting quality control (QC) assignments from QC manager, reviewing documents, ensuring timelines are met, etc.
• Act as central point person between the Global Medical Writing Lead (GMWrL) and the document working group.
• Provide intellectual leadership and contributes document knowledge and expertise to the document working group.
• Within assigned therapeutic area, assign fixed and flex writers to projects and ensure new writers are paired with a mentor. Update assignment tracker accordingly.
• Provide mentoring, training and oversight of writers within a therapeutic area to ensure high document quality and low writer turn-around. As required, performs the same tasks as when acting as head of a document working group.
• Act a senior medical writer within assigned therapeutic area.
• Prepare for and conducts interviews with prospective medical writing candidates.
• Participate in meetings to promote quality, efficiencies and value within the program.
• Assist senior staff with metrics.
• Act as line manager to Medical Writers