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Technical Writing Specialist, Ast

8 months ago

Basingstoke, United Kingdom Thermo Fisher Scientific Full time

A regulatory position within Thermo Fisher Scientific, Microbiology Division (MBD), working within the Regulatory Affairs (RA) Technical Writing Team as a Technical Writing Specialist to support MBD’s portfolio of clinical microbiology products.

As a Technical Writing Specialist, you’ll be working with the RA Technical Writing Team to support the compilation of Product Technical Files for the clinical microbiology product portfolio. You will work in accordance with standard operating procedures (SOPs) and mentorship from the Manager, Technical Writing Team to ensure work is carried out within schedule.

**Responsibilities**:
Working closely with the RA Technical Writing Team, you will be jointly accountable for the following:

- Ensuring the accurate compilation of Product Technical Files to align with IVDR 2017/746.
- Maintenance of Product Technical File templates.
- Coordinating and implementing design changes to Product Technical Files following feedback from internal and external collaborators.
- Advising Technical Writers on product-specific enquires as a product Subject Matter Expert.
- Participating on the MBD Product Technical File Review Committee as a Subject Matter Expert, undertaking timely and detailed review of Product Technical Files compiled by technical writers.
- Working on cross functional projects involving Technical, RA, QA and commercial departments.

**Experience, skills & abilities required**:
We’re looking for someone who:

- Has a Microbiology (or another biological science related) degree or experience in microbiology laboratory setting
- Has knowledge of in vitro microbiological diagnostic devices
- Shows proficiency with Microsoft Office software including Word and Excel
- Demonstrates good organisational and interpersonal skills
- Has high energy, with perseverance in a high pace environment
- Consistently demonstrates our 4i Values of Integrity, Intensity, Innovation & Involvement
- Puts the Customer First
- Thinks and acts with the customer always in mind and is dedicated to meeting or exceeding customer expectations
- Can explain who their customers are, and how their daily work impacts the customer
- Owns Their Results
- Takes personal accountability for their daily presence, performance, and productivity and always exercises good judgement
- Is highly reliable and consistently meets or exceeds job requirements
- Takes personal accountability for adherence to safety, compliance, quality, and security
- Finds a Better Way Every Day
- Adopt continuous improvement, asks questions and seeks opportunities to learn from others and from new experiences
- Takes the initiative to share ideas on how to make jobs easier and strengthen our performance

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.