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Sanofi
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Global Medical Expert

Global Medical Expert

Sanofi

5 - 9 years

0 Lacs

hyderabad telangana

Posted:2 days ago| Platform: Shine logo

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Skills Required

stakeholder management communication skills time management risk management medical editing medical writing medical regulatory writing clinical evidence monitoring strategic documents drafting common technical documents writing compassionate use approval

Work Mode

On-site

Job Type

Full Time

Job Description

The Sanofi Business Operations team in India centralizes processes to support various functions within Sanofi globally, such as Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. The team aims to be a strategic partner for Medical, HEVA, and Commercial organizations. As a member of the Medical regulatory writing team, your main responsibilities will include developing medical expertise in regulatory writing, ensuring compliance with FDA, EU, and other regulatory requirements, supporting activities related to marketing authorizations, and collaborating with Global Medical Leads and other departments. Key job duties and responsibilities include providing medical assessments, drafting strategic documents, writing key medical/clinical parts of Common Technical Documents, reviewing compassionate use requests, delivering high-quality medical documents, and collaborating effectively with stakeholders. You will be expected to maintain effective relationships with stakeholders, interact with medical and pharmacovigilance departments, and assist in developing knowledge and sharing expertise within the team. Additionally, you should ensure deliverables are supported as per timelines and quality standards, provide medical strategic insights, and act as an expert in medical regulatory writing. The ideal candidate will have 5 years of experience in supporting international pharmaceutical companies, soft skills including stakeholder management and communication, technical skills in medical operational excellence and editing, a Medical degree (MBBS; MD), and excellent knowledge of the English language. Join the Sanofi team to pursue progress, discover extraordinary achievements, and contribute to better medications and outcomes through collaboration and innovation. Apply now and be a part of a diverse and inclusive team dedicated to making miracles happen.,

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Sanofi

Pharmaceutical Manufacturing

Paris France

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Global Medical Expert