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Job Summary
This position requires an excellent resource that does development of Clinical Evaluation Plans/Reports (CERs) and Post Marketing Reports with future additional for development of other clinical evidence documents as part of the Medical Device Regulation and Medical Device Directive. This is an excellent opportunity to grow your career and improve quality of life for people around you.
Role- Clinical Medical writer
Location – Pune / Bangalore / Hyderabad
Experience – 5 to 15 Years
Principal duties and Responsibilities
Author and conduct medical and technical writing of clinical evaluation reports (CERs) in support of compliance to EU MDR- Med Dev 2.7, rev 4 for devices across therapeutic areas
Author and review post-market clinical follow up (PMCF) plan and PMCF reports
Summarize post-marketing surveillance and risk management data for the target device
Work cross-functionally to ensure adherence to submission and company-driven deadlines
Collaborate with stakeholders and participate in client calls and supporting work stream leaders
Providing product guidance and expertise to conduct literature searches on products/product families.
Review the literature and interpret and summarize risks, alternate therapies and device specific benefits from literature; collect and summarize primary data to support risk assessment.
Conduct proofreading, editing, document formatting, review comment integration and document completion/approval activities
Support senior writers to prepare regulatory documents that meet client expectations in terms of content, quality, and presentation
Expected areas of competence (i.e., knowledge, skills and abilities)
Exemplary knowledge of clinical evaluation processes and medical device development
Ability to understand and interpret complex clinical data
Strong, concise scientific style of writing with a high level of attention to detail
Demonstrated strong writing and communication skills
Ability to function well as a member of the team and build relationships between Clinical Affairs and other areas of the organization
Proven analytical and negotiation skills
Intermediate computer skills, including Microsoft Office Suite
Ability to lead a team and influence others
Proficient knowledge of EU regulations (MDR/MDD) and regulations outside of the EU
Education/Experience Requirements
Masters or Bachelors degree in Biomedical, Medical, life sciences or related field preferred. Alternate degrees may be considered