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Global Medical Expert

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Sanofi

2mo ago

  • Job
    Full-time
    Senior Level
  • Research & Development
    Healthcare
  • Hyderabad, +1

AI generated summary

  • You need 5 years in medical affairs or clinical development, therapeutic area expertise, strong communication, a medical degree (MBBS/MD), and excellent English skills.
  • You will develop medical expertise, oversee regulatory documents, collaborate with stakeholders, ensure compliance, and assist in medical writing needs for strategic deliverables.

Requirements

  • 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, anti-infectives, internal medicine
  • Stakeholder management; communication skills; and ability to work independently and within a team environment
  • As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, Excellent technical (medical) editing and writing skills)
  • Medical degree MBBS; MD
  • Excellent knowledge of the English language (spoken and written)

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.
  • 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, Benefit-Risk assessments, Expert statements for MDD, Responses to Health Authority Queries, Ad-hoc literature analyses, and labeling documents for the corresponding therapeutic area or products or any other activities which are the core activities of GMLs.
  • 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.
  • Writing of Key medical/clinical parts of Common Technical Documents (CTD) or Briefing packages (BP).
  • Reviewing and approving compassionate use of individual medical requests for use of Sanofi medicinal products for serious or life-threatening diseases for treatment outside of clinical trials.
  • Secure delivery of high-quality medical documents on time and in compliance with internal and external standards.
  • 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.
  • 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.
  • Interact effectively with stakeholders in medical and pharmacovigilance departments.
  • Constantly assist the medical regulatory writing team in developing knowledge and sharing expertise.
  • 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.
  • Provide medical strategic insights & evaluation related to Sanofi’s portfolio.
  • Contribute to the management of the marketing authorization dossiers of the current related portfolio.
  • Act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries, and teams supported.
  • Assist the assigned medical team in conducting comprehensive medical regulatory writing-needs analysis.
  • Implement relevant elements 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 the defined process.
  • Assist the head of scientific communications in designing an overall plan of action based on end-customers feedback & improving course content and delivery.
  • 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 ensure relevant & customized are delivered per expectation.

FAQs

What is the job title for this position?

The job title for this position is Global Medical Expert.

Where is the location for this job?

The job is located in Hyderabad or Mumbai.

What type of employment is this position?

This position is permanent and full-time.

What percentage of travel is expected for this role?

Travel is required as per business need.

What qualifications are required for this position?

A medical degree such as MBBS or MD is required.

How much experience is necessary for this role?

A minimum of 5 years of experience supporting international pharmaceutical companies in medical affairs, clinical development, or pharmacovigilance is necessary.

Which therapeutic areas should the candidate have experience in?

The candidate should have experience in at least one of the therapeutic areas: cardiovascular, metabolism, diabetes and lipid, CNS, oncology, anti-infectives, or internal medicine.

What soft skills are required for this job?

Stakeholder management, communication skills, and the ability to work independently and within a team environment are essential soft skills.

What technical skills are needed for this role?

Technical skills including medical operational excellence, time and risk management skills, and excellent technical (medical) editing and writing skills are needed.

What is the main responsibility of the Global Medical Expert?

The main responsibility is to provide medical assessments, develop medical expertise in regulatory writing, ensure compliance with regulatory requirements, and collaborate with various stakeholders.

In which activities will the Global Medical Expert be involved?

The Global Medical Expert will be involved in developing medical regulatory content, drafting strategic documents, reviewing compassionate use requests, and collaborating with medical and regulatory teams.

Is knowledge of languages other than English required?

Excellent knowledge of the English language (spoken and written) is required; knowledge of other languages may be beneficial but is not specified.

Does Sanofi provide equal opportunities?

Yes, Sanofi provides equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

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Sanofi

Science & Healthcare
Industry
10,001+
Employees
2004
Founded Year

Mission & Purpose

We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.