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, 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 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, Investigator’s 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.
Functie-eisen
Job requirements:
Education:
- Requires an advanced degree in a scientific discipline or a bachelor’s 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
Competenties
Competencies:
- Excellent writing, editing, verbal and interpersonal communication skills and a strong attention to details.
- Ability to critically analyze, synthesize, and communicate/present complex scientific information from a broad range of scientific disciplines and clinical therapeutic areas.
- Ability to adapt and work through conflicts to create consensus.
- Ability to manage/prioritize multiple projects from conception to completion, working in a fast-paced environment.
- Able to assign drop-in work or even upcoming projects.
Arbeidsvoorwaarden
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.
Work Location: Remote / Work-from-home
Work Schedule: Flexible schedule of at least 20 hours a week, with the understanding that the workload fluctuates, and the worker may need more hours to complete the work. There are times when work slows, so the client needs writers to understand there might be a drop in hours.
Engagement Model: Freelance/ Independent contractor
Start date: No later than September. It takes time to get an onboarding and training on processes at the company.
Bedrijfsinformatie
About the Company:
A multinational pharmaceutical company providing innovative medicines in areas of health where there is urgent need for better treatments.
Inclusiviteit en diversiteit
Uiteraard staat deze vacature open voor iedereen die zich hierin herkent. We geloven dat diverse teams van belang zijn voor ons als lerende organisatie, die voorop wil blijven lopen in de wereld van werk. Want juist verschillen tussen mensen zorgen voor groei. Van collega's, klanten, kandidaten en daarmee van Yacht. Heb jij een uniek talent? We ontmoeten je graag.