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

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