How will you make an impact?
The Genetic Testing Solutions group is a team of passionate individuals who are deeply committed to making the world healthier through development of molecular assays. This role will be part of a team developing and commercializing products for both research and clinical applications on Thermo Fisher Scientific sample-to-answer platforms.
The ideal candidate will be a team player who is passionate about delivering high quality diagnostic products. The candidate must be detail oriented, passionate about clear and concise scientific communication, and able to build strong relationships with internal and external stakeholders to move deliverables along very tight timelines. The candidate must be technically oriented, able to exercise independent judgment, and capable of handling projects with minimal direct guidance & supervision. Candidates with a strong scientific background and experience in medical device product transfer are preferred.
Job responsibilities include:
- Develop and update scientific/technical documentation from information provided by R&D scientists, project managers, and other team members.
- Proactively solicit information from other experts within the company as needed (e.g. R&D, Manufacturing, QA, QC, Legal)
- Maintain integrity of documents to comply with and be incorporated into the company’s quality procedures
- Write clearly and concisely to meet the needs of the target audience
- Work with minimal supervision and manage time effectively
- Identify and communicate risks to project deadlines in advance
- Estimate and schedule complex documentation projects
- Follow all processes, style guides, templates, and brand guidelines
- Actively participates as a member of cross-functional new product development teams to ensure compliance with design controls per ISO 13485 and FDA QSR.
- Helps in creation of DHFs and technical files to meet applicable standards.
How will you get there?
BSc in Life Science degree ( Advanced degree preferred) with 1+ year of experience in medical device/IVD or in technical writing.
- Strong understanding of ISO 13485, ISO 14971, FDA QSR - 21 CFR Part 820, and IVDR
- Strong understanding of Design Control & Change control
- Excellent written and verbal communication skills
- Demonstrates passion for problem solving and outside-the-box thinking
- Ability to write clearly, concisely, accurately, and quickly under tight deadlines.
- Keen attention to detail and high regard for quality.
- Experience working in a self-driven, performance/results oriented, fast paced matrixed environment.
- Must be highly collaborative; enjoys working in a diverse team and contributes to a positive work environment