Vinod Singh

About Vinod Singh

I am a proactive and achievement-oriented professional with over 23 years of experience in Leadership, Team Management, Regulatory and Safety Medical Writing, Clinical Data Management, Biostatistics & Programming, and Medical Practice. Proficient in delivering solutions that remedy core business issues and position the organization to reach the next level of profitability through technology introduction.I have experience in project management and implementation skills that have resulted in repeated success in guiding sizeable, cross-functional, & multi-geographical teams. Expertise in steering bidding & responding to RFPs and managing high net worth account.• Successfully established scalability across services• Meritoriously transformed multiple opportunities into business across medical writing service• Experience in setting up Medical Writing QC department in an organisation. Deep subject expertise of Authoring Clinical Study Report, Patient narratives and good command on DSUR.• Effectively administered Request For Proposal (RFP) responses through tailored proposals• Received numerous accolades and award throughout my career

Experience

1. Senior Manager Global Regulatory Writing

   Amgen

   Jul 2025 — Present · IN

Education

• ACADEMY FOR CLINICAL EXCELLENCE

  PGD-CLINICAL RESEARCH, Clinical Research

  2007 — 2007

• ICFAI

  Master of Business Administration (MBA), Business Administration

  2009 — 2012

• University of Mumbai

  BAMS, MEDICINE

  1995 — 2001

Skills

• Edc
• Therapeutic Areas
• Ctms
• Medical Writing
• Ich-Gcp
• Clinical Trials
• Gcp
• Relationship Building
• Vaccines
• Pharmacovigilance
• Business Strategy
• Project Management
• Good Clinical Practice (Gcp)
• Team Building
• Immunology
• Clinical Data Management
• Leadership
• Clinical Development
• Pharmaceutical Industry
• Sop
• Negotiation
• Oncology
• Protocol
• Meddra
• CRO