Global Medical Expert
Global Medical Expert
Posted on :
27-01-2025
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1 Vacancy
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Job Description
Job Title: Global Medical Expert
Job Location: Hyderabad Telangana India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Job title: Global Medical expert
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
Works with a team of Medical regulatory writers with different levels of expertise Develops medical expertise within Medical regulatory writing (on contents methods and processes). Ensures compliance with regulatory requirements from various regions (FDA EU others) for activities supported. Coordinates and supports medical activities related to the maintenance of the marketing authorizations of Established and Generic products in different therapeutic areas. Works in close collaboration with Global Medical Leads Global Regulatory Affairs Global Pharmacovigilance and vendors
Essential Job duties and responsibilities: 1) Responsible to provide a medical assessment with relevant and updated clinical evidence and monitoring the execution of strategic documents such as PBRERs ACOs DSURs Clinical Overviews BenefitRisk assessments Expert statements for MDD Responses to Health Authority Queries Adhoc literature analyses and labeling documents for the corresponding therapeutic area or products or any other activities which are the core activities of GMLs. 2) Drafting the extended synopsis of studies in collaboration with RWE experts. He/she will be responsible for overseeing the execution of such plans by the respective operational units in compliance with SOP GCP and other regulations. 3) Writing of Key medical/clinical parts of Common Technical Documents (CTD) or Briefing packages (BP). 4) Reviewing and approving compassionate use of individual medical requests for use of Sanofi medicinal products for serious or lifethreatening diseases for treatment outside of clinical trials. 5) Secure delivery of highquality medical documents on time and in compliance with internal and external standards. 6) Collaborates effectively with stakeholders: global medical leads/ medical product leads global regulatory affairs medical regulatory writing global or local teams pharmacovigilance teams managed access program teams.
Better is out there. Better medications better outcomes better science. But progress doesn’t happen without people – people from different backgrounds in different locations doing different roles all united by one thing: a desire to make miracles happen. So let’s be those people.
At Sanofi we provide equal opportunities to all regardless of race colour ancestry religion sex national origin sexual orientation age citizenship marital status disability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
- Grade: NA
- Hiring Manager: Head Scientific Communications/ Team lead
- Location: Hyderabad/ Mumbai
- % of travel expected: Travel required as per business need
- Job type: Permanent and Full time
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
Works with a team of Medical regulatory writers with different levels of expertise Develops medical expertise within Medical regulatory writing (on contents methods and processes). Ensures compliance with regulatory requirements from various regions (FDA EU others) for activities supported. Coordinates and supports medical activities related to the maintenance of the marketing authorizations of Established and Generic products in different therapeutic areas. Works in close collaboration with Global Medical Leads Global Regulatory Affairs Global Pharmacovigilance and vendors
Essential Job duties and responsibilities: 1) Responsible to provide a medical assessment with relevant and updated clinical evidence and monitoring the execution of strategic documents such as PBRERs ACOs DSURs Clinical Overviews BenefitRisk assessments Expert statements for MDD Responses to Health Authority Queries Adhoc literature analyses and labeling documents for the corresponding therapeutic area or products or any other activities which are the core activities of GMLs. 2) Drafting the extended synopsis of studies in collaboration with RWE experts. He/she will be responsible for overseeing the execution of such plans by the respective operational units in compliance with SOP GCP and other regulations. 3) Writing of Key medical/clinical parts of Common Technical Documents (CTD) or Briefing packages (BP). 4) Reviewing and approving compassionate use of individual medical requests for use of Sanofi medicinal products for serious or lifethreatening diseases for treatment outside of clinical trials. 5) Secure delivery of highquality medical documents on time and in compliance with internal and external standards. 6) Collaborates effectively with stakeholders: global medical leads/ medical product leads global regulatory affairs medical regulatory writing global or local teams pharmacovigilance teams managed access program teams.
- People: 1) Maintain effective relationships with the end stakeholders (Medical regulatory pharmacovigilance 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 the medical regulatory writing team in developing knowledge and sharing expertise
- Performance: 1) Secure deliverables (PBRER ACO SO CSR ID Cards Investigator brochure clinical evaluation report briefing packages medical section of CTA CTD SBRAs MDD HAQs or any other activities which are core activities for GMLs) are supported as per agreed timelines and quality
- Process: 1) Provide medical strategic insights & evaluation related to Sanofi’s portfolio. 2) Contribute to the management of the marketing authorization dossiers of the current related portfolio. 3) Act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries and teams supported. 4) Assist the assigned medical team in conducting comprehensive medical regulatory writingneeds analysis 5) Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region 6) Work with selected vendors when required within the region to deliver the required deliverables as per the defined process 7) Assist the head of scientific communications in designing an overall plan of action based on endcustomers feedback & improving course content and delivery
- 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 ensure relevant & customized are delivered per expectation
- Experience: ≥5 years of experience supporting international pharmaceutical companies: medical affairs clinical development pharmacovigilance with experience in at least one of the therapeutic areas cardiovascular metabolism diabetes and lipid CNS oncology antiinfectives internal medicine
- Soft skills: Stakeholder 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)
- Education: Medical degree MBBS; MD
- Languages: Excellent knowledge of the English language (spoken and written)
Better is out there. Better medications better outcomes better science. But progress doesn’t happen without people – people from different backgrounds in different locations doing different roles all united by one thing: a desire to make miracles happen. So let’s be those people.
At Sanofi we provide equal opportunities to all regardless of race colour ancestry religion sex national origin sexual orientation age citizenship marital status disability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
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Employment Type
Full Time
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