Summary
Location
Gif-sur-Yvette
Type
full-time
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About this role
Nous sommes un groupe pharmaceutique à dimension humaine, international et indépendant, gouverné par une Fondation. Notre modèle, singulier, fait notre fierté mais, surtout, nous permet de servir pleinement notre vocation : « Engagés pour le progrès thérapeutique au bénéfice des patients ».
Aujourd’hui leader mondial en cardiologie, nous avons choisi de devenir un acteur focalisé et innovant en oncologie d’ici 2030, en ciblant des cancers difficiles à traiter et en y consacrant plus de 70 % de notre budget R&D. Un défi que nous poursuivons en parallèle du développement de notre activité générique pour un accès à des soins de qualité pour tous, et à moindre coût.
Nous ? 22 000 passionnés de plus de 50 nationalités, portés par un esprit d’entreprenariat. Chaque jour nous avançons avec et pour les patients, avec et pour nos équipes, portés par l’envie de prendre soin, d’oser, de nous développer, de nous engager pour être utiles à celles et ceux qui en ont besoin.
Venez vivre et contribuez à faire vivre notre engagement #MovedByYou
www.servier.com
Role Summary
The Senior Medical Writing Program Lead will be responsible for the creation of English-language medical writing deliverables at Servier, ensuring the high-quality, timely, and efficient development of clinical and regulatory documents that comply with internal and external standards. This role will 1) be the lead author of regulatory and other scientific documentation, 2) manage the overall collection of content from cross functional teams to produce documents according to company guidelines and international governmental regulations, 3) mentor junior writing staff, 4) manage external vendor writer activities and 5) be the Medical Writing Program Lead for a particular drug development franchise within Servier.
Primary Responsibilities
• Coordinate medical writing activities and deliverables at the asset program level
• Work cross-functionally to write clinical and regulatory documents in support of regulatory submissions to accurately and consistently present key clinical messages in accordance with program goals, regulatory requirements, standards, and guidelines
• Serve as the main medical writing contact on study teams, coordinating the efforts of cross-functional teams for document development
• Detailed scheduling and management of cross-functional team deliverables impacting document delivery at the program level
• Mentor and manage the work of more junior writers
• Manage the work and deliverables of contract/vendor writers
Education and Required Skills
• Bachelor’s degree in a relevant scientific/clinical/regulatory field required (graduate degree preferred)
• 7+ years of medical writing experience (dependent upon graduate degree)
• History of leading major submissions to health authorities, including INDs and MAAs
• History of authoring regulatory strategic documents in support of health authority interactions
• Excellent verbal and written communication skills
• Exceptional organizational skills and attention to detail
• Project management skills and proficiency with MS Project
• Proficiency with relevant software for document authoring, referencing and approval workflows
• Flexibility and agility with changing priorities and timelines
Travel and Location
• Some domestic and international travel will be required
• Located at Servier headquarters, Saclay, France
Nous sommes engagés pour l’égalité des chances et le développement des talents dans toute leur diversité. Nous accordons autant de valeur à l’expérience qu’à l’envie de s’engager au quotidien pour être utile au progrès thérapeutique au bénéfice des patients. Si vous vous reconnaissez dans cette offre et ces quelques lignes, saisissez cette opportunité de nous rencontrer.
Other facts
About SERVIER MONDE
Servier is a privately held international pharmaceutical company headquartered in France with a passion for innovation that has improved patients’ lives around the world. With $4.7 billion in annual sales Servier operates in almost 150 countries worldwide across five therapeutic categories including oncology, cardiovascular, immuno-inflammatory, neuroscience and diabetes.
Servier is founded on the principle of serving and governed by an independent non-profit foundation. With this unique operating model, the company can be deliberate about putting patients ahead of profits. In fact, Servier re-invests 25 percent of revenue into research and development each year.
Servier is committed to therapeutic progress to serve patient needs and strives to provide future generations with a world where quality healthcare is available and accessible to all.
See our community guidelines here: https://www.servier.us/community-guidelines
To report a suspected adverse event with a Servier product, please visit: https://www.servier.us/contact-us
What you'll do
- The Senior Medical Writing Program Lead will coordinate medical writing activities and deliverables at the asset program level, ensuring compliance with regulatory requirements. They will also mentor junior writers and manage external vendor writer activities.
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