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Clinical specialist (medical writer) @ Tata Elxsi

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 Clinical specialist (medical writer)

Job Description

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 5-10 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

Effective communication skills

Experience with client interactions

Job Classification

Industry: Miscellaneous
Functional Area / Department: Research & Development
Role Category: Pharmaceutical & Biotechnology
Role: Pharmaceutical & Biotechnology - Other
Employement Type: Full time

Contact Details:

Company: Tata Elxsi
Location(s): Pune

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Keyskills:   PostMarket Clinical FollowUp PMCF Plan Clinical Evaluation Plan CEP Clinical Evaluation Report CER StateoftheArt SOTA analysis PMCF Evaluation Report Systematic Literature Review CEP

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Tata Elxsi

Berger Paints India is one of the leading paint and coatings companies in India, offering a wide range of decorative, industrial, and protective paints. Its portfolio includes interior and exterior wall coatings, automotive finishes, and specialty industrial products. The company emphasizes innovati...