In medical writing, there is no danger in being too precise, only in being imprecise.
Over de functie
Yacht Life Sciences has a vacancy for a (Senior) Medical Writer. For the Medical Writing team of our client, we are looking for a (Senior) Medical Writer who is willing to work from home.
The main responsibility of the (Senior) Medical Writer will include the writing of plain language summary (PLS) for disclosure documents. This will be done for each study trial and provide background information on the clinical study along with the study results. By writing these documents, you must follow very specific guidelines, write for a layperson and try not to be too technical or scientific.
In a later stage, or when time allows, you could be assigned to work independently to write and edit Clinical Study Reports (CSR), Investigator’s Brochures, Clinical Trial Results postings, annual reports, briefing documents, INDs, licensing submissions (BLAs, MAAs), or other complex clinical regulatory documents across multiple therapeutic areas.
Furthermore, you participate in clinical project team meetings, other cross-functional team meetings and standards committees. As a (Senior) Medical Writer, you will ensure 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.
- 8+ years writing high-quality clinical and regulatory documents including clinical study reports across multiple therapeutic areas
- Plain language summary writing experience for disclosure documents
- Writing CSRs for pivotal/registration studies or writing clinical sections of licensing submissions
- Pharmaceutical industry experience required
- Fluency in English (both oral and written)
- Excellent writing, editing, verbal and interpersonal communication skills and a strong attention to details
- Experience writing for lay audiences
- 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
- Able to assign drop-in work or even upcoming projects
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.
This home-based position is preferred to do on a full-time base (40 hours per week). If part-time is desired, then a commitment of a minimal availability of 25 hours is needed. This role is open for freelancers (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.
Voor meer informatie neem je contact op met Edwin Parlevliet via telefoonnummer 06-12387998
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.