Senior Clinical Evaluation Medical Writer
Sr. Clinical Evaluation Medical Writer (24 month contract // Mounds View, MN): HM's Top Needs:
- Clinical Evaluation experience (end to end would be ideal)
- Experience with cardiac rhythm management devices (ideal)
- Experience with literature management tools (ReadCube is ideal)
Education and Years’ Experience Required: Bachelor’s degree with a minimum of 4 years of experience in clinical research/clinical evaluation/clinical evidence, or advanced degree with a minimum of 2 years of experience in clinical research/clinical evaluation/clinical evidenc e Descriptio n:This role is responsible for analyzing and integrating diverse clinical evidence to evaluate product safety and performance and identify potential data gaps or risks. The position leads and supports clinical evaluations in compliance with applicable global regulatory requirements, working closely with cross‑functional stakeholders to define clinical evaluation strategies and support regulatory interactions. The role requires maintaining current knowledge of clinical evaluation best practices and the evolving clinical and regulatory landscape, and producing clear, accurate, and high‑quality clinical documentation. Responsibilities also include supporting risk/benefit and state‑of‑the‑art assessments, managing document timelines, addressing regulatory feedback, and providing guidance or mentoring to colleagues as neede d. Duti
- es:Identify, compile and analyze multiple data types (clinical investigation results, literature and clinical experience, preclinical data, etc.) in order to evaluate product safety and performance and identify potential evidence g
- apsCollaborate, plan and develop clinical evaluations in accordance with relevant guidelines/regulations (i.e. CERs, clinical dossiers) with stakeholders from multiple functions and in compliance with applicable standards and in alignment with business ne
- edsDevelop and maintain therapeutic and device operation knowledge; apply this knowledge to the development of well-written, clear, and concise repo
- rtsIdentify potential evidence gaps or risks to existing data and work with stakeholders to assess options, track, and communicate risks as nee
- dedDevelop search strategies to identify and obtain existing, relevant data (internal or extern
- al)Stay current on clinical evidence landscape and provide guidance to teams on sufficient d
- ataDevelop and maintain in-depth knowledge of clinical evaluation best practices and regulatory agencies’ guidelines on clinical evaluation requireme
- ntsAssess other technical file documents against clinical data, available current literature, and industry state of the art (this may include risk management plans, IFU, e
- tc)Collaborate with other functional groups (R&D, clinical, quality, marketing, etc.) to conduct risk/benefit assessments and evaluate State of the Art for the therapy area and product l
- ineConduct proofreading, editing, document formatting, review comment integration, and document completion / approval activit
- iesAddress deficiencies and or answer questions from regulatory agencies as nee
- dedWork in close collaboration with cross-functional stakeholders to determine appropriate clinical evaluation strategy; may provide input to clinical trial des
- ignInterface with regulators and may lead discussions and develop strategies with cross functional stakeholders to negotiate and influence regulatory reviewers on the clinical evaluat
- ionProvide guidance, mentoring and coaching to colleag
- uesCreate and manage project schedule for each docum
- entMay lead the development of policies, procedures, and/or process improvement initiatives for the group or clinical departm
ent