Senior Manager, Medical Writing
Gilead SciencesSalary not specified
- Full Time
- Senior (5 to 8 years)
Thermo Fisher Scientific
Principal Regulatory Medical Writer (client-embedded) EMEA
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Biotechnology, Regulatory AffairsIndustries
Requirements
Candidates should possess a Bachelor’s degree in a scientific discipline or equivalent formal academic/vocational qualification, with an advanced degree preferred. They must have regulatory writing experience equivalent to 8+ years, along with experience in the pharmaceutical or CRO industry and managing complex medical writing projects. Experience with EU CTR guidelines and familiarity with structured content management systems, AI-driven content creation, and Natural Language Generation is preferred.
Responsibilities
The Principal Regulatory Medical Writer will lead the development, writing, and editing of complex clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submissions. They will collaborate with cross-functional teams, ensure documents align with regulatory guidelines and company standards, provide strategic input on document content, mentor junior medical writers, manage multiple projects, and stay current with industry trends and requirements.
Skills
Regulatory Medical Writing
Clinical and Regulatory Document Preparation
Clinical Study Reports
Protocols
Investigator Brochures
Regulatory Submissions (INDs, NDAs, MAAs)
Cross-functional Collaboration
Scientific Communication
Project Management
Thermo Fisher Scientific
Provides life sciences products and services
About Thermo Fisher Scientific
Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.
Key Metrics
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees