Assistant Manager at Meril

Qualification

B.Pharm, M. Pharm, Ph.D. in Life sciences

Experience

Must:

Minimum 3 years of experience  in medical device  regulatory document preparation including Clinical Evaluation Report, Post-Market Surveillance Report, Post-Market Clinical Follow-up Plan/Report etc.

Job Description

·         Lead (writing and reviewing) the development and completion of regulatory documents for medical devices including but not limited to:

a.       Clinical Evaluation Plan (CEP)/Report (CER)

b.      Post-Market Surveillance (PMS) Plan/Report

c.       Periodic Safety Update Report  (PSUR)for Medical devices

d.      Post-Market Clinical Follow-up (PMCF) Plans/Reports

e.      Summary of Safety and Clinical Performance (SSCP) Report

·         Conduct literature searches and clinical evidence mapping, manage the literature database, and prepare literature reviews

·         Work in a cross functional team and draft the regulatory documents

·         Facing internal and external regulatory audits

·         Develop and maintain SOPs and writing tools, such as templates and style manuals

Skills

·         A Bachelor degree with a minimum of 2 years of experience in scientific writing or an advanced degree with a minimum of 1 year experience in scientific writing

·         Strong verbal, written, and interpersonal communication skills

·         Knowledge in Medical Device regulatory process

·         Knowledge in Medical Device regulations including MEDDEV Rev. 4, MDR

·         Experience in conducting focused literature searches on PubMed, MedLine or other similar medical literature database

·         Basic understanding of Medical Writing, including familiarity with writing styles such as American Medical Association

·         Understanding of global regulatory agencies and regulatory processes concerning medical devices

·         Highly proficient in the use of Microsoft Office applications (Word, Excel, PowerPoint)

·         Ability to understand and interpret results of published literature and clinical studies; working knowledge of statistics is required

·         Ability to summarize complex results and present in a clear, concise, and scientifically accurate manner to a wide-range of audiences

·         Excellent writing and editing skills, and a keen attention to detail

·         Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail; ability to work in a fast-paced environment