Expert Medical Regulatory Writer
Sanofi Aventis
Full time- 8+ years
- Not Disclosed
- Hyderabad, India
- Post Date: Apr 19, 2024
- End Date: Jun 19, 2024
- 8+ years
- Not Disclosed
- Hyderabad, India
- Post Date:Apr 19, 2024
- End Date: Jun 19, 2024
Skills:
- pharma
- mbbs
- MD
Job Description:
Responsibilities
- 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: 1) Provide deliverables (CSR, CO, SCE, SCS, SCP, SBP, PBRER, ACO, RMP, ID Cards, clinical evaluation report, Briefing packages, HAQs, Immunogenicity reports) as per agreed timelines and quality 2) Fair understanding of Product Alerts, and trial transparency documents with the agility to learn and contribute to situations of demands
- Process: 1) Acts as an expert in the field of medical regulatory writing and maintains the regulatory requirement for countries supported. 2) Assist the assigned medical team in conducting 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 per the defined process. 5) Design an overall plan of action basis end-customers feedback & improve course content and delivery 6) Substantial understanding of Product Alert Process and Trial Transparency documents with the ability to quickly develop expertise and contribute swiftly if the situation demands
- Stakeholders: 1) Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Liaise with the Medical department to prepare relevant & customized deliverables. 3) Collaborate with CTT, CST, GCT and SMT. 4) Proactively liaise with the Clinical/Medical/Pharmacovigilance/Biostats/Regulatory/Legal/Regulatory/Corporate Affairs departments to prepare relevant & customized deliverables.
Qualification & Experience
- Experience: ≥8 years of experience in regulatory writing for the pharmaceuticals/healthcare industry
- Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment, leading project teams
- Technical skills: As applicable (including but not limited to therapeutic area/domain knowledge exposure; publication submission; and/or project management; Expert knowledge of and demonstrated accomplishment in global registration of drugs)
- Education: Advanced degree in life sciences/ pharmacy/ similar discipline (PhD, Masters, or bachelor’s in science, D Pharma, Pharm D) or medical degree (MBBS, BDS, BAMS, BHMS, MD)
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Salary
Not Disclosed
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Role
Medical Writer
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Area of Practice
- Medical Writing
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Experience
8+ years
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