**Job title** : _Global Medical expert_ + _Grade:_ _NA_ + _Hiring Manager:_ _Head Scientific Communications_ _/ Team lead_ + _Location_ _:_ _Hyderaba_ _d/ Mumbai_ + _% of travel expected_ _: Travel_ _required_ _as per business need_ + _Job type: Permanent_ _and_ _Full time_ _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:** _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 supporte_ _d._ _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, 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_ _. 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 life-threatening diseases for treatment outside of clinical trials._ _5)_ _Secure delivery of high-quality 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 team_ _s._ + _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 writing-needs 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 end-customers 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_ _About you_ + **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, anti-infectives, 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** : M _edical degree MBBS_ _;_ _MD_ + **Languages** : _Excellent knowledge of_ _the_ _English language (spoken and written)_ _Pursue progress, discover extraordinary_ 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 (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! **Pursue** **_progress_** **, discover** **_extraordinary_** 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, ability or gender identity. Watch our ALL IN video (https://www.youtube.com/watch?v=SkpDBZ-CJKw&t=67s) and check out our Diversity Equity and Inclusion actions at sanofi.com (https://www.sanofi.com/en/our-responsibility/equality-and-inclusiveness) ! Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com or via our movie We are Sanofi (https://youtu.be/96EwNjb1TLo) As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (http://www.youtube.com/watch?v=SkpDBZ-CJKw&t=2s)