CER - Project Manager

Job description:

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.

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 support 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

- Good verbal and written communication skills in English

- Excellent project management skills

- Knowledge about at least one project management tool - MS Project / JIRA / Agile etc.

- Should have hands-on experience in handling a team

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

- A minimum of 12-15 years of experience in handling projects pertaining to Clinical Affairs/Medical Writing (e.g. biomedical research, medical/regulatory/scientific writing, clinical trial management) required

- Experience handling a team of Medical writers

- Experience with client interactions

Qualification: BE/B.Tech in Biomedical Engineering/B.Pharm/MPharm/MBBS/BHMS/BAMS/BDS/ Life Science background

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