Regulatory Writer
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Job Location:
Steinhausen - Switzerland
Hourly Salary:
CHF CHF 110 - 150
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
Senior Regulatory Writer 24-Month Contract
Location: Allschwil Switzerland
Rate: CHF 110150/hour (depending on experience)
CK QLS is currently recruiting for a Senior Regulatory Writer to join a leading global pharmaceutical company on a 24-month contract basis. This role offers the opportunity to contribute to high-impact global submissions within a collaborative and fast-paced environment.
Role Overview
The Senior Regulatory Writer will be responsible for independently authoring and reviewing high-quality clinical and regulatory documents to support submissions to global health authorities. The role involves providing scientific and strategic input to project teams ensuring the effective communication and positioning of clinical data.
Key Responsibilities
All applications must have the right to work in Switzerland. Please quote 184892 in all communication.
Location: Allschwil Switzerland
Rate: CHF 110150/hour (depending on experience)
CK QLS is currently recruiting for a Senior Regulatory Writer to join a leading global pharmaceutical company on a 24-month contract basis. This role offers the opportunity to contribute to high-impact global submissions within a collaborative and fast-paced environment.
Role Overview
The Senior Regulatory Writer will be responsible for independently authoring and reviewing high-quality clinical and regulatory documents to support submissions to global health authorities. The role involves providing scientific and strategic input to project teams ensuring the effective communication and positioning of clinical data.
Key Responsibilities
- Author and review clinical regulatory documents including CTD Module II summaries Clinical Overviews and Clinical Study Reports (CSRs).
- Prepare responses to health authority questions briefing documents safety updates and investigator brochures.
- Provide scientific and strategic input to submission and study teams.
- Contribute to the planning and presentation of data analyses and review statistical documentation.
- Collaborate with cross-functional stakeholders including Clinical Sciences Biometry Drug Safety and Regulatory Affairs.
- Work with documentation specialists to ensure timely and high-quality deliverables.
- Support the selection and management of external regulatory writing vendors.
- Mentor and support junior writers.
- Bachelors degree in Life Sciences (Masters degree preferred).
- Minimum of 5 years experience in regulatory or medical writing within the pharmaceutical industry.
- Strong knowledge of regulatory guidelines and document requirements.
- Demonstrated ability to produce high-quality clinical and regulatory documentation.
- Experience across multiple therapeutic areas is advantageous.
- Excellent written and verbal communication skills in English.
- Ability to work independently manage competing priorities and meet deadlines.
All applications must have the right to work in Switzerland. Please quote 184892 in all communication.
About Company
Idibu
100 employees
Every business is now operating in an environment that’s susceptible to change. idibu has evolved against this changing backdrop. Whether driven by legislation, technology, customer demand or the economy, businesses now need to be agile and fleet of foot to ensure they can attr ... View more
