Manas Manu
Delivery Lead – Medical Writing | 18+ Years in Pharma, Medical Devices, & PV | Regulatory Compliance Expert
- Role
- Delivery Lead- Medical Writing at Tata Consultancy Services
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Manas Manu
Medical Writing Manager with vast experience in life sciences industry encompassing medical devices, pharma, and consumer, across Medical Writing (MW) and Pharmacovigilance (PV) domains.With proven ownership and leadership skills, consistently exceeding organizational expectations. Strong work ethics and ability to foster productive relationships within teams. Experienced in fast-paced deadline driven environments, effectively managing team goals and team development. History of success in collaborative settings, driving results and enhancing team performance.
Experience
Delivery Lead- Medical Writing
Mar 2023 — Present · Mumbai, IN
Steering a team of medical writers and senior medical writers for timely delivery high quality regulatory documents.Authoring and review of regulatory documents based on ICH, ISO, USFDA, EMA, and other required regulatory guidelines.
Education
Government Inter College, Sultanpur
Higher Secondary Schooling
2000 — 2002
Kamla Nehru Institute Of Child Education
Secondary Schooling
1995 — 2000
Lucknow Christian College, Lucknow University
B.Sc., Life Sciences
2002 — 2005
Reliance School of Life Sciences
Certificate Course, Clinical Research
2007 — 2007
HAL School Korwa, Amethi, Sultanpur
Primary Schooling
1988 — 1995
Amity University
M.Sc., Biotechnology
2005 — 2007
Skills
- Feasibility Studies
- Edc
- Ctms
- Lifesciences
- Clinical Trials
- Yello Belt Certified in Six Sigma
- Ich-Gcp
- Sop Development
- Team Management
- Medical Writing
- Mentoring of New Joinees
- Training
- Clinical Data Management
- Clinical
- Pharmaceutical Industry
- Sop
- Drug Safety
- Biotechnology
- Life Sciences
- Clinical Research
- Pharmacovigilance
- CRO
- Protocol
- Gcp
- Adverse Event Reporting
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