Hobson Prior are looking for a Principle Medical Writer to join a global pharmaceutical organisation on a permanent basis in New Jersey, with the flexibility to work from home. Our client is focused on developing novel vaccines to tackle pandemic threats and diseases all over the world. As the Principle Medical Writer, you will be responsible for planning, preparing, managing and coordinating medical writing projects for CD.
- Responsible for planning and preparing high quality medical writing deliverables (e.g., study protocols, clinical study reports, statistical analysis plans, Investigator Brochures, relevant modules of regulatory dossiers, risk management plans, pharmacovigilance ad hoc and periodic reports, briefing books), presentations (e.g., abstracts, posters, Advisory Committees, Advisory Boards) and manuscripts that support the clinical development and regulatory requirements for CD.
- Accountable for continues improvement of in-house medical writing.
- Partakes in the development of medical-writing related Best Practices, SOPs work instructions, style guides and content guides to ensure efficient preparation of high-quality medical writing deliverables.
- Provides input into the strategy for medical writing vendor selection, defines the scope of work to be outsourced and is responsible for medical writing vendor management.
- Delivers expert medical writing support.
- Excellent organisational and time management skills.
- Strong written and oral communication skills.
- Excellent interpersonal skills.
- Attention to detail.
- A solid understanding of the Clinical Development Process, including the documents that are required at each stage of development.
- High degree of influencing skills in shaping and developing content and wording.
- Demonstrated ability to work collaboratively; demonstrated negotiating skills and resourcefulness.
- An excellent understanding of all aspects of ICH GCP, SOPs, and international publication planning guidelines.
- Successful track record of leading complex clinical / regulatory writing projects.
- Applies good judgement and demonstrates initiative.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.