Regulatory Writer

3 days ago


Hyderabad, Telangana, India Lifelancer Full time

Company Overview



Sanofi Global Hub is a strategic partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, globally.



About the Job

We are seeking a skilled Regulatory Writer to create high-quality medical content for our clients in the pharmaceutical industry.



Your primary responsibility will be to develop and maintain TA expertise, reviewing content created by peers' writers, and collaborating effectively with Scientific communication global or local teams.



Key Responsibilities


  1. Participate independently in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer.
  2. Develops and maintains TA expertise.
  3. Reviews content created by peers' writers.
  4. Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, Regulatory Teams and Corporate Affairs Teams based on the documents assigned.
  5. Maintain effective relationships with end stakeholders within the allocated Global business unit and product.
  6. Interact effectively with stakeholders in medical and pharmacovigilance departments.
  7. Constantly assist other medical regulatory writers in developing knowledge and sharing expertise.


Performance Metrics


  • Provide deliverables (PBRER, ACO, CSR, Product and Disease ID Cards, clinical evaluation report, Briefing packages, Medical section of CTA, managing Product Alerts, posting of trial information such as study protocol and amendments, study results, redacted documents, lay summaries on websites) as per agreed timelines and quality.
  • Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness.


Required Skills and Qualifications


  • Experience: >5 years of experience in regulatory writing for the pharmaceuticals/healthcare industry.
  • Soft skills: Stakeholder management; vendor management; communication skills; and ability to work independently and within a team environment.
  • Technical skills: As applicable (including but not limited to Medical operational excellence, time, and risk management skills, excellent technical (medical) editing and writing skills, data retrieval, interpretation of scientific data, medical literature screening, knowledge of ICH and GCP/GVP, ability to summarize scientific information and edit text for specific audiences, well-versed with computer applications).
  • Education: Advanced degree in life sciences/pharmacy/similar discipline (PhD, Masters or bachelor's in science, D Pharma, PharmD) or medical degree (MBBS, BDS, BAMS, BHMS, MD).
  • Languages: Excellent knowledge of the English language (to read, write, and speak).


Benefits

Pursue progress, discover extraordinary better medications, better outcomes, better science. At Lifelancer, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.



Estimated Salary: ₹12,50,000 - ₹18,00,000 per annum based on location and experience.



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