Yacht Life Sciences has a vacancy for an experienced Medical Writer. For the Medical Writing team of our client, we are looking for a (freelance/ ZZP) Medical Writer who will focus on writing clinical protocols and protocol amendments. This is a fully home-based position.
The responsibilities of the Protocol Writer may include, but are not limited to the following:
- Works independently to write and edit clinical protocols and protocol amendments.
- Negotiates timeline development for preparation of clinical protocols and amendments.
- Leads the process of critical review of clinical protocols and incorporates multiple reviews into successive drafts.
- Provides QC support for clinical protocols as needed.
- 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 protocols by maintaining and promoting familiarity with ICH, GCP, and other standards.
- Writing and editing clinical study reports, Investigator’s Brochures, Clinical Trial Results postings, annual reports, and other clinical regulatory documents across multiple therapeutic areas could be assigned as well.
- Bachelor or Master in a scientific discipline
- Must have 4+ years writing high-quality clinical protocols and protocol amendments across multiple therapeutic areas
- Pharmaceutical industry experience is required
- Fluency in English (both oral and written)
- Availability of 40 hours per week
- 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.
- Proficiency in Microsoft Office applications.
- Familiarity with CTD, ICH, GCP and other standards.
- Ability to manage/prioritize multiple projects from conception to completion, working in a fast-paced environment.
If you match our criteria, please send in your motivation and resume. Based on the incoming applications, we select and invite candidates for an interview.
Full-time secondment contract via Yacht. This role can be performed by a freelancer/ ZZP as well. We will offer a competitive benefits package in line with the seniority of the position. You will become a member of a strong professional network who shares your education, ambitions and competencies. This will enable you to interact with your colleagues and become a member of the YACHT network, which stretches the Life Science industry. You will be challenged by your peers and will be able to follow courses and training via our Yacht Academy and keep your knowledge and skills up-to-date: boosting your career through personal and scientific growth.
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.