Medical Writer Drug Regulatory

Providing Flexible Resourcing Solutions

Medical Writer Drug Regulatory

• Reference Number: 04-09-133-MWDR-CRf
• Type of placement: Permanent
• Location: Switzerland, Basel area

Responsibilities:

• Writing and reviewing clinical regulatory documents such as clinical study reports, investigator’s brochures, and CTD Module II summaries, in collaboration with Regulatory Project Managers, Clinical Science Leaders, and the International Project Team
• Assisting in the preparation and review of clinical study protocols and statistical analysis plans
• Working together with the in-house Documentation Group to produce high-quality documents in compliance with regulatory requirements
• Coordinating the support of external medical writing services

Qualifications and experience:

• A degree in life sciences (BSc and/or MSc/PhD)
• English mother tongue
• Well developed and proven medical writing skills
• 2 – 3 years of experience as a medical writer in the pharmaceutical industry across several therapeutic areas
• Knowledge of regulatory document requirements and guidelines
• The ability to work independently and as part of a team
• The ability to work under pressure and meet challenging deadlines
• Excellent interpersonal and presentation skills
• Relevant working/residency permit or Swiss/EU-Citizenship

What we offer:

• A competitive salary and generous social benefits
• The possibility for development and advancement within a constantly growing company
• The innovative and stimulating atmosphere of a multicultural environment