Medical Affairs Specialist Iii

4 months ago

Birmingham, United Kingdom Thermo Fisher Scientific Full time

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 - To enable 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.

Our work in specialty diagnostics - from providing diagnostic assays and instruments to clinical monitoring across disease stages - improves the diagnosis and management of blood cancers and immune system disorders. Your determination to put patients at the heart of every decision will improve health outcomes that people and communities depend on - now and in the future.

**Birmingham
- Hybrid
- 3 days office**

Would you like to be part of an organisation which is committed to improving patient lives worldwide through education, collaboration and innovation?

Do you want to make a difference?

If the answer is ‘**yes**’ then you’re just the kind of person we’re looking for

**Medical Affairs Specialist III**

**Main duties and responsibilities**:
**NPD and claim extension support**
- Define (with the cross functional team) Intended Purpose, User Needs, Design Inputs.
- Determine patient harm and its severity and probability in the context of TBS products for risk management.
- Define clinical study strategy, perform directed literature searches, write Scientific Validity Reports, Clinical Performance Plans and Clinical Performance Study Plans, liaise with Clinical Affairs for study site screening and selection.
- Analyze study data and write Clinical Performance Study Reports and Clinical Performance Reports.
- Contribute to regulatory submissions (including FDA and IVDR) and FDA pre-submissions.
- Provide company-wide scientific training and marketing support for assigned NPDs.

**Scientific collaborations**:

- Initiate and handle externally sponsored scientific studies, handle the approval and maintain the documentation of such trials.
- Establish and handle KoL relationships.
- Generate evidence (posters, peer-reviewed publications).
- Represent TBS in professional organizations and at scientific conferences, including the presentation of data.

**General**
- Maintain an expert understanding of clinically relevant analytes, disease areas and clinical utilities.
- Analysis of internal and external studies, clinical trends and practices to support company objectives.
- Maintain a comprehensive understanding of relevant TBS science, including the biochemistry of target antigens, our launched assays, and the pathophysiology and investigation of immunological disorders and relevant haematological malignancies.
- Respond to internal and external requests for scientific information relating to R&D products.
- Occasional international and national travel required, to attend conferences and meetings with customers/collaborators.

**Person specification**
- PhD in Immunology/Biochemistry and/or equivalent combination of education and work-related experience (e.g. healthcare professional).
- At least 1 year experience of working in an NHS/routine healthcare laboratory, industry IVD environment, Medical Affairs, or clinical trials role.
- Excellence in scientific communication (written and verbal).
- Data management skills (i.e., basic statistical analyses and data handling, interpretation of scientific data, and development of graphics).
- To be flexible to the needs of the business. There will be occasional requirement to work in the evening and on weekends due to the global nature of the business and travel requirement.

**This role is a hybrid position (3 days from HQ office, 2 days from home per week).**

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 Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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.

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