Senior Medical Writer/ Protocol Writer (Yacht Life Sciences)
Yacht Life Sciences has a vacancy for an experienced Medical Writer. For the Medical Writing team of our client, we are looking for a full-time Senior Medical Writer who will focus on writing clinical protocols and protocol amendments.
The responsibilities of the Senior Medical Writer may include, but are not limited to the following:
- Works independently to write and edit clinical protocols and protocol amendments. In addition, 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.
- Negotiates timeline development for preparation of clinical protocols and if needed other clinical regulatory documents.
- Leads the process of critical review of clinical protocols and incorporates multiple reviews into successive drafts.
- Provides QC support for clinical protocols as needed.
- Reviews 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.
- Demonstrates critical thinking in the analysis and presentation of clinical study data.
- 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.
- 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 protocols and protocol amendments across multiple therapeutic areas (a strong experience with Oncology is preferred).
- Pharmaceutical industry experience is required.
- Writing CSRs for pivotal/registration studies or writing clinical sections of licensing submissions is strongly preferred.
- Fluency in English (both oral and written).
- Background in biologics is a plus.
- Must be located in (the proximity of) Leiden
- Excellent writing, editing, verbal and interpersonal communication skills and a strong attention to details.
- Experience writing and editing ICH-compliant clinical regulatory documents according to CTD structure.
- 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.
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.
Voor meer informatie neem je contact op met Edwin Parlevliet via telefoonnummer +31 0612387998
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.