Principal Medical Writer
A privately held pharma-company is advertising a vacancy for a Principal Medical Writer, based in their office in Switzerland. The company is active in the life sciences areas of drug development, GMP manufacturing of proprietary drugs, diagnostic tools, and investment management, and focuses on innovative treatments, such as in oncology with a focus on solid tumours, as part of their business. This is an exciting opportunity to work with a leading pharmaceutical organization and support their R&D operations to create new, viable treatments.
- Authoring clinical and regulatory documents such as study protocols and amendments, ICFs, CSRs, IBs, Pediatric Investigation Plans, Briefing Books, Requests of Product Specific Waivers, applications for Orphan Drug Designations, and responses to health authorities; the documents should be accurate, suited for the intended audience, and easy to read.
- Triggering annual IB reviews and potential updates.
- Collaborating closely with internal specialists/colleagues/departments to obtain/provide information, ensure smooth review process, incorporate editorial comments, and solve queries to present a 'finished' final document within the required deadline.
- Ensuring, understanding, and implementing international quality standards (ICH GCP) and internal company procedures.
- Facilitating document review meetings and discussions.
- Contributing to the development of project timelines.
Skills and Requirements:
- 3-5 year of experience in writing protocols, protocol amendments, briefing books, study reports, Health Authority responses, IBs, CSRs, ICFs.
- Experience in early phase clinical development in Oncology.
- In-depth knowledge of writing guidelines (e.g. EMA, FDA, ICH, AMA, etc.) used for the preparation of clinical documents.
- Working knowledge of the clinical drug development process, clinical trials design and biostatistics, with experience in integrating information into clinical-regulatory documents.
- Experience with effectively managing vendors and contract writers to meet timelines/project objectives.
- Knowledge of science or an aptitude for understanding it, including the ability to learn new therapeutic areas quickly.
- Familiarity with medical terminology.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Patrick Franke at +44 02074400632 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.