跳至主要内容
两名身穿白色实验室外套的女性一起看着电脑屏幕

Global Medical Expert

印度 Permanent 发布日期 01/07/2024
立即申请

Job title: Global Medical expert

  • 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

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 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, 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 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 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 toMedical 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)

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 and check out our Diversity Equity and Inclusion actions at sanofi.com!

立即申请
  • 您还没有查看任何职位。

  • 您还没有保存任何职位。

白板上的男人指着演示文稿并看着同事

查看所有职

我们的产品设计师负责帮助人们提高免疫力,物流专家负责将药物送到需要的人手中,而数据分析师则借助先进的技术改善人们的生活。在医疗健康领域,每一次进步都离不开所有人的努力。您可以自由选择自己的职业发展道路。Gig零工项目将帮助您尝试更多岗位,个性化指导将为您挖掘自己从未被发现的优势。加入我们,开启菲凡的职业发展之路。您到底可以走多远?让我们拭目以待!

体验可能性

  • 我们的办公地点

    我们的员工遍布60多个国家/地区。他们勠力同心,携手共创医疗健康领域的美好未来。无论您在哪里工作,我们的专家都会指导您推动职业发展,您也将能够运用先进的科学技术,取得意义非凡的重大突破。

    了解更多
  • 勇敢追梦,奔赴美好未来

    想要改变自己的生活,乃至改变全球数百万人的生活,该怎么做?加入我们,开启职业新篇章,然后在我们的保驾护航中展翅高飞,并向优秀的人求教,为这份事业做出切实的贡献。

    了解更多
  • 您和我们相互依存,共同成长

    我们精心打造薪酬体系,为您的身心健康、财务健康与社交健康提供全面保障。我们有着海纳百川的包容性团队文化,无论您在哪个岗位,都能展翅高飞。

    了解更多
  • 心怀梦想,成就一番事业

    我们希望您以饱满的热情投入到自己的工作岗位中,给全球数百万人带来美好生活。您的职业发展道路由您自己来掌控。您只管制定目标,我们会提供充足的培训机会和支持,让您得偿所愿。

    了解更多
  • Ama

    Ama puts her project management techniques and ServiceNow knowledge to use to help advance Sanofi’s Digital Data operating model. Learn how our team connects data and AI to do what’s never been done before.

    了解更多
  • Cambridge Crossing

    We're bringing together 2,500 people from across our organization — R&D, Medical, Commercial and Global colleagues all working to realize the power of collaboration.

    了解更多
  • Innovation in Action

    Our flexible lab of the future will transform how we conduct research, while our innovation center will be fully integrated with existing R&D locations.

    了解更多
  • Sanofi’s AI Centre of Excellence in Toronto

    The Centre is focused on using leading technologies to develop world-class data and artificial intelligence (AI) products to create value for the health sector.

    了解更多
  • Sanofi Canada's Philanthropic Efforts

    By chasing the miracles of science to improve people’s lives, we surprise ourselves with what we can achieve. Our team is humbled by the impact our efforts make.

    了解更多
  • Sustainable and Green

    Our new facility was built to minimize the environmental impact — helping protect our planet and people. Using resources efficiently, we're providing greener, healthier workspaces.

    了解更多
  • 我们的人与文化

    我们是首个建立多元化、公平性和包容性(DE&I)委员会的制药企业。我们还建立了“菲常联盟”,为每位员工提供发声的平台。您的声音是我们建设未来道路的重要基石。

    了解更多
  • 我们的故事

    我们关注每一个员工的声音。因为,我们的未来取决于所有员工的付出与努力。正因为他们的助力,我们才能追求远大的理想。

    了解更多
  • 为什么选择我们?

    我们为您提供各种工具、支持和培训机会,帮助您实现自己的目标。我们也希望您充分发挥潜力,帮助我们实现目标:将新药研发到临床治疗的时间减半。

    了解更多
  • 您保存的职位

    了解更多