Sanofi Medical Regulatory Writers Vacancy - Apply Online

Sanofi Medical Regulatory Writers Vacancy – Apply Online

Sanofi Job. Career at Sanofi. Pharma Candidates with a Master’s degree are encouraged to apply online at Sanofi for Senior Medical Regulatory Writer vacancies that are available. Sanofi is hiring Pharma candidates for Senior Medical Regulatory Writer vacancies

Job title: Senior Medical Regulatory Writer

Direction: Medical

Location: India

Report to: Head Medical Regulatory writing

Functional Reporting to (when applicable) NA

Qualifications

  • Advanced degree in pharmacy/ similar discipline or medical degree (PhD – Master in science)
  • Excellent English language knowledge

Requirements of the job

5 years of experience in regulatory writing for the pharmaceuticals/healthcare industry
Experience in at least one of the Therapeutic area – Cardiovascular, metabolism, Diabetes and Lipid, CNS, Oncology, Anti-infectives, Internal medicine.

Mission statements

  • Write and/or edit under guidance high quality clinical and safety documents, medical section of Periodic Benefit-Risk Evaluation Report, an addendum to clinical overview, Clinical Study Reports (CSR), ID Cards, Investigator brochure, clinical evaluation report, Briefing packages, Medical section of CTA..
  • Delivery of high-quality medical documents in time and in compliance with internal and external standards
  • Participate in the planning of analysis and data presentation to be used, initially in conjunction with the mentoring medical writer.
  • Develops and maintains TA expertise
  • Reviews content created by peers writers

Collaboration

  • Scientific communication global or local teams
  • Medical regulatory writing global or local teams
  • Pharmacovigilance teams

Duties & Responsibilities

1.People

Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product – with an end objective to develop medical regulatory content as per requirement
Interact effectively with stakeholders on medical and pharmacovigilance departments
Constantly assist other medical regulatory writers in developing knowledge and sharing expertise Feedback from stakeholders (end customers, medical teams) on overall satisfaction

2.Performance

Provide deliverables (PBRER, ACO, CSR, ID Cards, Investigator brochure, clinical evaluation report, Briefing packages, Medical section of CTA ) as per agreed timelines and quality
Adherence to timeline Adherence to quality target

3.Process

Act as an expert in the field of medical regulatory writing and maintain on the regulatory requirement for countries supported. Assist the assigned medical team in conducting comprehensive medical regulatory writing-needs analysis Implement relevant element of the medical regulatory plan and associated activities for the year identified for the region
Work with selected vendors when required within the region to deliver the required deliverables as per defined process Design an overall plan of action basis end-customers feedback & improve course content and delivery Feedback from stakeholders (end customers, medical teams) on satisfaction with services provided Adherence to Plan / Calendar

4.Customer

Work closely with Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables Liaise with the Medical department to prepare relevant & customized deliverables Feedback from stakeholders (end customers, medical teams) on satisfaction with services provided Knowledge, Skills & Competencies / Language

Therapy Area Exposure

  • Diabetes
  • Familial hypercholesterolemia
  • Cardiovascular disease
  • Multiple sclerosis,
  • Immunology
  • Oncology
  • Market access
  • Emerging markets
  • Generics
  • Vaccines
  • Vitamins and supplements
  • Digestive
  • Allergies
  • Parkinson
  • Haemophilia
  • Rare diseases
  • Rare blood diseases

Apply Online

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