Chief Pharmaceutical Regulatory Content Developer

3 days ago

Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 28,00,000
Senior Safety Writer Job Description">

As a Senior Safety Writer, you will play a crucial role in creating and reviewing safety reports for global regulatory submissions. This includes Annual Reports, Periodic Safety Update Reports, and Development Safety Update Reports.

  • Develop and edit various safety reports to ensure compliance with regulatory requirements.
  • Author and review Risk Management Plans (RMPs), adhoc reports, and medical device reports.
  • Draft responses to health authority questions or feedback and collaborate with cross-functional stakeholders.
  • Cultivate the skills of peers and junior team members through training and mentorship opportunities.
  • Prepare manuscripts, abstracts, and posters for conferences.
  • Perform signal detection activities and author signal reports.
  • Support writing coaches, devise training programs, and author/review SOPs/WIs/process documents.
  • Coordinate report writing activities across a team of writers, if applicable.
  • Assist in resource estimation and responding to Requests for Proposals (RFPs).
  • Foster internal and external communication to obtain required inputs.
  • Create and update labels, review literature searches, and perform routine surveillance.
  • Implement efficient processes to meet timelines and deliverables.
Qualifications:
  • Bachelor of Pharmacy degree
  • 7 to 11 years of experience in pharmaceutical regulatory writing
  • Expert proficiency in English language
  • Strong problem-solving skills and ability to think creatively
  • Commitment to diversity, inclusion, and equal opportunity employment

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