Excellent opportunity as a Senior Medical Regulatory Writer at Sanofi – Apply Now

Step Into the Spotlight: Join Sanofi Hyderabad as a Senior Medical Regulatory Writer! B. Pharma/D. Pharma Graduates, this is your chance to shine in the pharmaceutical regulatory arena. Sanofi Hyderabad invites passionate individuals to join our esteemed team, contributing as Senior Medical Regulatory Writers.

Seize the opportunity to leverage your pharmaceutical expertise and writing skills in a dynamic environment. Be a part of our mission to bring life-changing medicines to patients worldwide. Apply now and take the next step in your career with Sanofi Hyderabad!

Job Title: Senior Medical Regulatory Writer

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)

Experience: >5 years of experience in regulatory writing for the pharmaceuticals/healthcare industry

Skills
1. Soft skills: Stakeholder management; vendor management; communication skills; and ability to work independently and within a team environment
2. 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)

Languages: Excellent knowledge of the English language (to read, write, and speak).

Main responsibilities:
Write and/or edit high-quality safety and clinical documents, medical sections of Periodic Benefit-Risk Evaluation Reports, medical sections of Addendum to clinical overviews, Clinical Study Reports (CSR), Disease and product ID Cards, and clinical evaluation reports, product alerts and trial transparency documents with added knowledge and expertise. Delivery of high-quality medical documents on time and in compliance with internal and external standards and guidelines. Works independently on documents with minimal supervision, and act as buddy or mentor to the medical writers, and efficiently peer reviews.

Essential Job duties and 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.

People:
1) 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.
2) Interact effectively with stakeholders in medical and pharmacovigilance departments.
3) Constantly assist other medical regulatory writers in developing knowledge and sharing expertise.

Performance: 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 such as CTG (ct.gov), EUCTR, EUDRACT) as per agreed timelines and quality

Process:
1) Author, review, act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries supported.
2) Assist the assigned medical team in conducting a comprehensive medical regulatory writing needs analysis.
3) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region.
4) Work with selected vendors within the region to deliver the required deliverables as per the defined process.
5) Design an overall plan of action basis end-customers feedback & improve course content and delivery.
6) Prepare/review stand-by statement and questions and answer (SBS QA) document as part of managing Product Alerts.
7) Track postings, file, or archive material in relevant systems, and ensure audit and inspection-readiness.
8) Remain abreast of Sanofi Policy or Quality Documents evolution.

<<<<<<<<<<<<MORE JOBS>>>>>>>>>>>>>>

<<<<<<<<<<<<JOIN US>>>>>>>>>>>>>>>>