Job Description:
Yacht Life Sciences has a vacancy for a (remote) Principal Medical Writer. For the Medical Writing team of our client, we are looking for a (freelance) Principal Medical Writer who is willing to work from home.
The responsibilities of the Principal Medical Writer may include, but are not limited to, the following:
Works independently to write and edit clinical study reports, Investigators 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 required (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.
It''s important to have experience with documentation like: clinical protocols, INDs, BLA''s, MAA''s, SOP''s, clinical study reports, Investigators Brochures, Clinical Trial Results postings, annual reports. Written articles about these subjects (journalism), or shadowed the making of above documents, isn''t what this position is about. You have to have written these types of documentations in the pharmaceutical/clinical field.
Job requirements:
Education:
Requires an advanced degree in a scientific discipline or a bachelors degree with equivalent work experience. MSc or PhD in biological science preferred.
Experience:
Must have 6+ years writing high-quality clinical and regulatory documents including clinical study reports across multiple therapeutic areas.
Writing CSRs for pivotal/registration studies or writing clinical sections of licensing submissions required.
Experience writing and editing ICH-compliant clinical regulatory documents according to CTD structure.
Proficiency in Microsoft Office applications.
Familiarity with CTD, ICH, GCP and other standards.
Pharmaceutical or biotechnological industry experience required.
Fluency in English (both oral and written).
Background in biologics is a plus.
Availability between 20 - 40 hours per week