Senior Medical Writer - Home-based
Clinipace is a global, full-service contract research organization (CRO); our approach to clinical research is personal. We deliver a level of collaboration and flexibility not possible in a traditional CRO environment. Clinipace places an emphasis on personalised services and solutions, regulatory expertise, and therapeutic leadership. Our mission is to improve the way clinical research is performed in major therapeutic areas including oncology, rare diseases, gastroenterology, nephrology, and women’s health. Clinipace strives to impact the future of drug development and health care by combining the most advanced technology and a CHALLENGE ACCEPTED approach. With offices in 23 countries and more than 850 professionals worldwide, our personalized services and solutions mean we are designed to face the most difficult industry challenges and guide our clients successfully through their clinical development programmes.
To continue to develop and support our client services, Clinipace is currently recruiting a Senior Medical Writer to join our Global Medical Writing group.
Senior Medical Writer
(Home-based)
We are looking for a Senior Medical Writer with the right skills and experience to join our focussed team of regulatory writers based in Europe, North America and Asia Pacific.
Global Medical Writing (GMW) sits within the Medical Affairs Department, so besides authoring typical study-level documentation and assisting our Regulatory Strategic Development (RSD) colleagues with marketing applications, Clinipace medical writers also contribute expertise on safety and pharmacovigilance documents.
Clinipace medical writers are experienced scientists with strong statistical backgrounds and proven expertise in timely and accurate preparation of study-level and other regulatory documentation. In return, the medical writing department offers a competitive compensation package, an excellent learning environment, and a group of colleagues who place emphasis on mutual support. Put simply, we are a friendly bunch of people to work with.
The GMW team structure is collaborative rather than hierarchical, and therefore creates a dynamic learning environment. Medical writer education and development are high priorities for the Head of Clinipace GMW, and alongside delivering a first class service to our clients, the suitable candidate will be given the chance to learn about and implement new and developing areas of medical writing - such as COVID-19, public disclosure, and the role of big data in clinical trials.
Job Qualification
Qualifications required:
- A university degree in the field of science or medicine, graduate/postgraduate degree is highly preferred
- At least 5 years of relevant medical and regulatory writing experience in the pharmaceutical industry, CRO experience is a plus
- Excellent written and verbal communication skills in English
- Proven track record in preparing clinical and regulatory documents with minimum supervision.
Responsibilities in your new role will include:
- Preparation of clinical and regulatory documents, including individual study-level documentation (e.g. CSRs and protocols), drug development plan support (e.g. IBs), PV documentation (e.g. DSURs), and clinical and non-clinical summary documents
- Expanding your expertise within the devices area and requirements under the Medical Device Regulation (MDR)
- Coordinate overall internal and quality review of documents
- Manage large and complex medical and regulatory writing projects
- Provide support to other medical and regulatory writers to ensure delivery of documents according to timelines and within budget and to acceptable quality standards.
Are you ready to accept the CLINIPACE CHALLENGE?
How to apply: Submit your CV in English. Applications to imorrison@clinipace.com
No third-party applications.