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About Company

Sun Pharma, the world’s fourth largest specialty generic pharmaceutical company and No. 1 in India, invites applications for the position of Officer in Medical Writing. Join us and be part of a global team that delivers high-quality, affordable medicines to over 100 countries.

Position Name :

Medical Writing

Organization :

Sun Pharma

Qualification:

B. Pharma/ M.Sc/ M.Pharma/ PhD/ BAMS/ BHMS

Experience:

N/A

Salary:

N/A

Location:

Pune

Key Responsibilities:

  • Prepare high-quality clinical protocols, investigator brochures, regulatory documents, data reviews, clinical study reports, publications, and related clinical documents.
  • Write manuscripts, prepare posters/abstracts for conferences, and coordinate with vendors for outsourced activities.
  • Assist in the procurement of clinical scales.
  • Ensure compliance with clinical and regulatory guidelines and internal SOPs for clinical trials.
  • Review protocols for new trials in collaboration with the operations team.
  • Coordinate review processes for study synopsis from clinical, regulatory, and operational perspectives.
  • Prepare and review SOPs specific to medical writing for clinical trials.
  • Work closely with medical monitors on reviewing study documents and data review activities.
  • Lead and recommend process improvement initiatives.
  • Evaluate metrics to assess performance and implement plans for improvement.
  • Use systems like MedDRA and WHO-DD for data coding, including coding of adverse events and drugs.
  • Understand randomization procedures and blinding techniques used in clinical trials.

Activities:

  • Prepare protocols, Clinical Study Reports (CSRs), and SOPs in line with ICH GCP and regulatory requirements.
  • Conduct literature searches for protocol, CSR, and manuscript writing.
  • Write clinical journal manuscripts, abstracts, and study articles for publication.
  • Present protocols and clinical study reports at subject expert committee (SEC) regulatory meetings.
  • Collaborate with vendors for manuscript writing, abstract/poster preparation, and procurement of clinical scales/PROs.
  • Coordinate with data management teams for data review and database lock.
  • Engage early with biostatisticians for sample size certification and review of statistical analysis plans.
  • Register on clinical trials registries (e.g., CTRI).
  • Ensure medical writing deliverables conform to ICH and other regulatory guidelines.
  • Create and maintain SOPs and work instructions for medical writing deliverables.
  • Mentor and lead less experienced medical writers on complex projects.

Requirements:

  • Strong medical writing skills with a background in life sciences.
  • Familiarity with guidelines such as IMRaD, CONSORT, GCP/GDP regulations, ICMR guidelines, and the Drugs and Cosmetic Act.
  • Experience working in a matrix business environment is preferred.
  • Demonstrated success through annual performance ratings or professional accomplishments and awards.
  • Strong knowledge of clinical research and medical writing activities.
  • Ability to collaborate in a matrix environment and think strategically.
  • Excellent writing, communication, and interpersonal skills.
  • Proficiency with Excel or statistical software tools.
  • Self-awareness and adaptability to work in a dynamic environment.
  • Result-oriented and performance-driven.

Physical Requirements/Working Conditions:

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

Selection Process:

  • The selection will be based on an interview.
  • Mode of Interview: Face-to-Face
  • Interview Rounds: HR