Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
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Currently we have an FSP opening for Reg Affairs Manager - CMC writer with focus on Medical Devises.
Key Responsibilities
- Preparation and update of high-quality Design History Files to state of art regulatory compliance for both inhaled and injectable combination products, using varied information sources and liaising closely with other company personnel to ensure accuracy of such records. Work to agreed deadlines, with ability to respond readily to changing events and priorities.
- Preparation and update of Design History Files for Combination Products in accordance with current regulatory requirements across US and EU primarily
- Assist in compiling General Safety and Performance Requirements (GSPR) checklists for devices
- Assist in regulatory strategy planning for Combination Product submissions
- Assist in risk assessment processes
- Update SOPs and/or create new SOPs to detail ways of working
Required Skills:
- Experienced in Medical Device/ Combination Product CMC based regulatory affairs.
Good written and oral communication skills. - Demonstrated ability to focus, working with attention to detail and retaining critical information.
- Demonstrated team working skills, with the ability to establish strong relationships and liaise effectively with client sites worldwide.
- Demonstrated effective time management skills.
Experience:
- Global experience, (with a specific focus on US/ EU requirements), in Combination Products.
- Working experience in generating and developing Design History Files for Combination Products.
- Lifecycle management of Medical Devices / Combination products.
- Understanding of the operation of Veeva Vault document management system
Management Role:
No people management responsibility
What we offer:
At PPD Clinical Research Services we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD Clinical Research Services truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.