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 Writing Document Manager. For the Medical Writing team of our client, we are looking for a Senior Medical Writing Document Manager who is located in Europe and is willing to work from home.
The responsibilities of the Senior Medical Writing Document Manager may include, but are not limited to the following:
- Acts as head of a document working group for multi-component projects with strategic aspects (e.g., marketing applications, Investigational New Drug (IND) applications, responses to regulatory authorities, etc.).
- Coordinates, manages and facilitates the tasks necessary for document drafting, review and completion within a document working group. This may include drafting timelines, requesting quality control (QC) assignments from QC manager, reviewing documents, ensuring timelines are met, etc.
- Acts as central point person between the Global Medical Writing Lead (GMWrL) and the document working group.
- Provides intellectual leadership and contributes document knowledge and expertise to the document working group.
- Within assigned therapeutic area, assigns fixed and flex writers to projects and ensures new writers are paired with a mentor. Updates assignment tracker accordingly.
- Provides mentoring, training and oversight of writers within a therapeutic area to ensure high document quality and low writer turn-around. As required, performs the same tasks as when acting as head of a document working group.
- Acts a senior medical writer within assigned therapeutic area.
- Prepares for and conducts interviews with prospective medical writing candidates.
- Participates in meetings to promote quality, efficiencies and value within the program.
- Assists senior staff with metrics.
- Acts as line manager to Medical Writing Document Manager and Medical Writers
- 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 8+ years writing high-quality clinical and regulatory documents including clinical study reports across multiple therapeutic areas
- Must have experience with leading a team
- Writing CSRs for pivotal/registration studies or writing clinical sections of licensing submissions is required
- Pharmaceutical industry experience is required
- Fluency in English (both oral and written)
- Background in biologics is a plus
- Experience with Immunology, Infectious Disease, CNS/Pain and/or Frontier Diseases is a plus
- 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.
This is a full-time position which can be performed home-based within the EU.
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 multi-national 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.