Pharmaceutical Medical Writer
2 weken geleden
Job Description
We are looking for a skilled Principal Medical Writer to join our team at Yacht Life Sciences. As a Principal Medical Writer, you will be responsible for writing and editing clinical study reports, Investigator's Brochures, Clinical Trial Results postings, annual reports, and other clinical regulatory documents across multiple therapeutic areas.
Key Responsibilities
- Work 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.
- Work 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.
Requirements
- Requires an advanced degree in a scientific discipline or a bachelor's degree with equivalent work experience.
- MSc or PhD in biological science preferred.
- 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.
Terms of Employment
- This concerns a full-time, remote position for 20-40 hours per week.
- We will offer a contract for 1 year with the possibility of extension and a fixed contract directly at the company.
- This role can be performed as a freelancer within the EU.
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