Medical Regulatory Writer
Medical Regulatory Writer
Posted on :
20-01-2025
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1 Vacancy
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Job Description
Job Title: Medical Regulatory Writer
Job Location: Hyderabad Telangana India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level: Entry level
About The Job
Our Team:
Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care Vaccines General Medicines CHC CMO and R&D Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical HEVA and Commercial organizations in Sanofi globally.
Main Responsibilities
Write and/or edit under guidance highquality safety documents medical section of Periodic BenefitRisk Evaluation Report medical sections of Addendum to clinical overview Disease and Product ID Cards product alerts and trial transparency documents. Delivery of highquality medical documents in time and in compliance with internal and external standards and guidelines.
Essential job duties and responsibilities: 1) Participate with support 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) 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.
Our Team:
Sanofi Business Operations is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care Vaccines General Medicines CHC CMO and R&D Data & Digital functions. Sanofi Business Operations strives to be a strategic and functional partner for tactical deliveries to Medical HEVA and Commercial organizations in Sanofi globally.
Main Responsibilities
Write and/or edit under guidance highquality safety documents medical section of Periodic BenefitRisk Evaluation Report medical sections of Addendum to clinical overview Disease and Product ID Cards product alerts and trial transparency documents. Delivery of highquality medical documents in time and in compliance with internal and external standards and guidelines.
Essential job duties and responsibilities: 1) Participate with support 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) 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 Product and Disease ID Cards 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 and 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 endcustomers feedback & improve course content and delivery. 6) Prepare/review standby 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 inspectionreadiness. 8) Remain abreast of Sanofi Policy or Quality Documents evolution.
- Stakeholders: 1) Work closely with Clinical/Medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Proactively liaise with the Clinical/Medical/Pharmacovigilance/Biostats/Legal/Regulatory/corporate affairs departments to prepare relevant & customized deliverables.
- Experience: >2 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 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 wellversed 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 English language knowledge (to read write and speak)
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Employment Type
Full Time
Key Skills
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