Senior Medical Writer
CK QLS are recruiting for a Senior Medical Writer to join a rapidly growing biopharmaceutical company at their site based in Basel-Landschaft on a on a contract basis for until the end of 2020, with the possibility of extension.
Company: This company is a rapidly growing biopharmaceutical company that is discovering, developing innovative medicines.
Location: This Senior Medical Writer role will be based at our clients site in Allschwil just outside of Basel.
Senior Medical Writer Role:
- Write and manage review and approval of clinical and regulatory documents, such as clinical study reports (CSRs) and high-level clinical summaries and overviews.
- Contribute scientifically and strategically at the project and/or study team level to facilitate efficient development of high-quality clinical documents for regulatory filing, e.g. provide input on pooling strategy, provide content expertise and guidance, and advise regarding regulatory requirements and ICH guidance.
- Contribute to the planning of data analyses and presentation for CSRs and submission documents; review statistical analysis plans.
- Support writing of responses to health authority questions, as required.
- Work together with the in-house Editorial Group to produce high-quality documents in compliance with internal company standards and external regulatory requirements.
- Participate in process and technology improvement initiatives related to regulatory writing and documentation.
- Manage the work of external medical writers, as needed.
- Mentor/train less experienced writers.
Your Background:
- University degree in life sciences or other relevant scientific discipline required. Advanced degree is desirable.
- Fluent English spoken and written skills.
- Previous experience in writing regulatory documents.
- Well-developed and proven medical writing skills, combined with an ability to interpret and present complex scientific data from different disciplines in a clear, concise format.
- Proven global regulatory submission experience.
- Excellent knowledge of global regulatory environment, including key document requirements, reporting guidelines and approval processes.
- Strong ability to work under pressure and prioritize multiple deadlines and projects.
- Ability to work independently and as part of a team.
- Attention to detail.
- Excellent interpersonal and communication skills.
Apply: For more information or to apply for this Senior Medical Writer, please contact Jocelyn on 0041 (0) 782 516 595 or email applicationsqls@ckqls.ch. Please could you send any correspondence in English. Please quote reference 47182 in all correspondence.