Safety and Compliance Specialist

2 days ago

Mumbai, Maharashtra, India beBeeRegulatory Full time ₹ 5,00,000 - ₹ 8,00,000

Our team is seeking a talented Senior Regulatory Writer to join our ranks. As a key member of our global content creation team, you will play a vital role in crafting high-quality safety reports and regulatory documents for clients worldwide.

Key Responsibilities:

  • Develop and review comprehensive safety reports for regulatory submissions, including Annual Reports, Periodic Safety Update Reports, and Development Safety Update Reports.
  • Author and review Risk Management Plans, ad hoc reports, Benefit-Risk Evaluation reports, and medical device reports.
  • Draft Common Technical Document Summaries, including Non-Clinical and Clinical Overviews, Clinical Summaries, and other regulatory documents as assigned.
  • Train peers and junior team members on best practices and provide hands-on experience.
  • Collaborate with cross-functional stakeholders to manage and track feedback from health authorities.
  • Write/review manuscripts, abstracts, and posters for conferences.
  • Prepare medical information responses for Healthcare Professionals (HCPs).
  • Conduct signal detection activities and participate in signal/safety review meetings with clients.
  • Act as a writing coach, developing training programs, and authoring/reviewing SOPs/WIs/process documents.
  • Coordinate report writing activities across a team of writers if applicable.
  • Assist with resource estimation and responding to RFPs as needed.
  • Facilitate internal and external communication to gather required inputs.
  • Resolve issues affecting project deliverables and ensure compliance with regulatory requirements.

Requirements:

  • Bachelor's degree in a relevant field.
  • Exceptional communication skills and attention to detail.
  • Experience in writing safety reports and regulatory documents.
  • Proficiency in SQL, Python, and Core Java preferred.
  • Ability to mentor junior team members and conduct trainings.
  • Strong analytical and problem-solving skills.
  • Familiarity with regulatory requirements and guidelines.
  • 1-8 years of relevant experience.

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