Clinical Medical Writer Lead

6 days ago


Mumbai, Maharashtra, India SUN PHARMA Full time

Job Description

SUN PHARMA is seeking an experienced Clinical Medical Writer Lead to join our team in Mumbai, India. As a key member of our medical writing group, you will be responsible for leading the development of high-quality clinical trial documents, including protocols, clinical study reports, and investigator brochures.

About the Role

This is a challenging and rewarding opportunity for a skilled medical writer who wants to take on a leadership role. You will work closely with cross-functional teams, including operations, regulatory, and biostatistics, to ensure that clinical trial documents are accurate, compliant, and meet regulatory requirements.

Key Responsibilities

  • Lead the development of clinical trial documents, including protocols, clinical study reports, and investigator brochures
  • Work closely with cross-functional teams to ensure accuracy, compliance, and quality of clinical trial documents
  • Develop and maintain SOPs and guidelines for medical writing activities
  • Mentor and lead less-experienced medical writers on complex projects
  • Collaborate with vendors for manuscript writing, abstract/poster preparation, and procurement of clinical scales/PROs
  • Coordinate with data management team to ensure timely review of data extracts and data cleaning activities
  • Register clinical trials on relevant registries
  • Ensure compliance with ICH and other relevant regulatory guidelines

Requirements

  • Bachelor's degree in Life Sciences or related field (M.Sc./Ph.D. preferred)
  • Minimum 5 years of experience in medical writing, preferably in a pharmaceutical industry
  • Excellent medical writing skills and knowledge of clinical research and medical writing activities
  • Strong understanding of GCP/GDP regulations and ICMR guidelines
  • Experience working in matrix business environments preferred
  • Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments

Competencies

  • Strong medical knowledge of different therapeutic areas
  • Sound functional knowledge of clinical research and medical writing activities
  • Collaboration and teaming with ability to work in a matrix environment
  • Strategic thinking & sound analytical skills
  • Good writing and communication skills
  • Sense of urgency & desire to excel

Physical Requirements/Working Conditions

The role is based at Sun House, Mumbai. Occasional travel related to official work may be required.



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