Medical Writing Scientist H/F
www.servier.com
Within Clinical Development, join our international Medical Writing team, responsible for elaborating regulatory and scientific documents supporting development of our future treatments we will deliver to patients, from pre-clinical phase to post-registration phases.
Your role as a Medical Writing Scientist is to :
- BE an active lead author of regulatory and scientific nonclinical and clinical documents
- Manage the overall collection of content from cross functional teams to produce documents according to company guidelines and international regulations
- Manage external vendor writers' deliverables
Your main responsibilities :
- Ensure that nonclinical and clinical documents (eg, study reports, study protocols, summaries/overviews, investigator's brochures, agency response documents, and other global regulatory submission documents as appropriate) accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements, and that continuity and consistency of clinical data are maintained from concept to licensing and disclosure.
- Edit, write, develop and maintain timelines, project management, and participation on project teams.
- Serve as main medical writing contact on study teams.
- Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents.
- Ensure that deliverables meet all applicable regulations, standards, and guidelines, including ICH guidelines.
- Manage the work and deliverables of contract/vendor writers, as needed.
- Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOPs. Work cross-functionally to update procedures or practices as needed to remain within regulatory compliance and to improve internal quality and efficiency.
This role 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.
Profile & Skills
- Advanced degree in a relevant scientific field preferred; Bachelor's degree required.
- 2+ years of medical writing experience (dependent upon graduate degree)
- Experience as a lead writer/medical writing point of contact for marketing applications (NDA/BLA) preferred.
- Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs.
- Demonstrated ability to remain flexible should priorities change (judgment and decision making) during project execution.
- Ability to understand complex biological concepts relevant to drug development such as molecular targets and pharmacology.
- Ability to manage multiple projects with competing priorities.
- Capacity to work within a study team with minimal supervision.
- At ease to work in a global team environment
- Excellent verbal and written English communication skills.
- Exceptional organizational skills and attention to detail
- Project management skills (MS Project experience preferred) and familiarity with GCP and ICH guidelines.
- Technical skills with relevant software for authoring such as MS Word and EndNote (ability to use PleaseReview and an abbreviation manager/QC tool is desirable)
- Desirable : Experience with nonclinical and clinical writing for marketing applications, Expertise with lay language summaries and public disclosure-related activities
Position is based on our R&D Campus in Saclay's innovation cluster
Quel que soit votre domaine d'expertise, votre travail au sein du Groupe Servier contribue à faire avancer le progrès thérapeutique au bénéfice des patients. Vous ferez partie d'équipes reconnues pour leur excellence scientifique et développerez votre plein potentiel dans un environnement professionnel qui vous encourage à vous développer. Des parcours d'intégration sur mesure, des opportunités de mobilité, des formations de qualité, un management responsable, un esprit d'équipe Tout cela et plus encore dans un lieu de travail axé sur votre bien-être.
Chez Servier, nous sommes engagés dans le progrès thérapeutique au service des besoins des patients. Nous mettons la diversité de nos collaborateurs comme une source de richesse pour l'accomplissement de cette vocation.