Senior Medical Writer

Hobson Prior are looking for a Senior Medical Writer to join a growing biopharmaceutical company in Switzerland who focus on discovering, developing and bringing more, pioneering medicines to patients. As the Senior Medical Writer, you will be responsible for writing and overseeing the writing of complex regulatory documents for submission to regulatory authorities in support of drug development and marketing applications.

Job Responsibilities:

• Write and manage review and approval of clinical and regulatory documents, such as clinical study reports 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.
• Contribute to the planning of data analyses and presentation for CSRs and submission documents; review statistical analysis plans.
• Work together with the in-house Editorial Group to produce high-quality documents in compliance with internal company standards and external regulatory requirements.
• Partake 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.
• As required, support writing of responses to health authority questions.

Key Skills:

• 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.

Requirements:

• University degree in life sciences or other relevant scientific discipline required. Advanced degree is desirable.
• English mother tongue, or excellent spoken and written English.
• A minimum of 5+ years of 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.

Apply now:

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.