Senior Manager, Medical Writing
Gilead SciencesSalary not specified
- Full Time
- Senior (5 to 8 years)
Thermo Fisher Scientific
Senior Regulatory Affairs Specialist - Central Labs
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Medical Devices, Laboratory ServicesIndustries
Position Overview
- Location Type: Onsite
- Employment Type: Full Time
- Salary: Not specified
- Company: Thermo Fisher Scientific Inc.
Description: Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. This role within the PPD® Laboratory Services team provides innovative solutions and regulatory expertise as a senior contact within the Global Central Labs at CRG. The position focuses on strategic regulatory intelligence and guidance, ensuring compliance with FDA/IVDR, CE regulations, CAP, and CLIA standards. It involves interacting with clients to deliver regulatory deliverables and acting as a liaison with internal and external clients.
Requirements
- Education: Bachelor’s degree or equivalent and relevant formal academic / vocational qualification.
- Experience: Previous experience providing the knowledge, skills, and abilities to perform the job (comparable to 5+ years).
- Skills:
- Strong English language (written and oral) communication skills.
- Solid attention to detail and quality.
- Strong editorial/proofreading skills.
Responsibilities
- Provides regulatory strategy and/or technical advice to internal and external clients.
- Acts as a liaison in executing regulatory strategies.
- Leads the development and implementation of project-specific processes for sponsors.
- Collaborates extensively with other departments, regulatory consultants, and regulatory authorities.
- Prepares and reviews regulatory guidance.
- Participates in project launch meetings, review meetings, and project team meetings.
- Supports business development activities by advising on regulatory implications for project delivery.
- Trains and guides junior team members as appropriate.
Application Instructions
- Not specified in the provided text. Please refer to the Thermo Fisher Scientific website (www.thermofisher.com) for application details.
Company Information
- Company: Thermo Fisher Scientific Inc.
- Mission: To enable our customers to make the world healthier, cleaner, and safer.
- Industry Leadership: World leader in serving science.
- Brands: Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.
- Website: www.thermofisher.com
Skills
Regulatory Strategy
Regulatory Guidance
FDA
IVDR
CE Regulations
CAP
CLIA Standards
Regulatory Liaison
Project Management
Communication Skills
Attention to Detail
Proofreading
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.
Waltham, MassachusettsHeadquarters
1956Year Founded
$17MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees