Requirements: English
Company: Sanofi EU
Region: Budapest ,
- Job title: Trial Disclosure Manager (TDM)
- Location: Budapest, Hungary
- Job type: Permanent, full-time
- Hybrid working
About the job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Were also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Join our global Clinical Documentation team as a Trial Disclosure Manager and youll ensure timely public disclosure of protocol information and study results, in line with regulatory requirements and Sanofi data sharing commitments. Youll work closely with clinical, statistics, regulatory, medical marketing, patents and pharmacovigilance colleagues, in order to get the best solutions to specific public disclosure challenges on behalf of Global Business Units while ensuring timeliness and quality of deliverables.
Main responsibilities:
- Works with colleague TDMs, study and/or project teams, in order to plan, prepare, and release registrations and results on appropriate website/s within the required timelines. As well, participates or leads activity in related process areas such as redaction of documents, preparation of summaries, management of public queries and others.
- Collaborates with colleagues and teams to drive resolution of specific disclosure challenges that may arise during product development and/or in relation to therapeutic specificities.
- Identifies and follows up CAPA in the event of deviations, for the assigned therapeutic or product area/s.
- Supervises consultant and/or vendor/s on selected disclosure activity, ensuring in partnership the timely production of high-quality deliverables for Global Business Units or other Customers.
- Participates in / contributes to / leads selected quality, technical, and/or process-driven activities in order to ensure complete and timely follow up of the defined deliverables.
- Trains or participates in delivery of selected training of colleagues, or Vendor, and similar communications.
- Has or develops knowledge of disclosure regulations, website standards, and company commitments / policy, and applies them appropriately in order to guide study, project teams, and colleagues, through appropriate communications.
About you
Experience:
Understanding of or exposure to the clinical development environment
Soft Skills:
Ability to summarize scientific information and edit text for specific audiences
Quality consciousness, attention to detail, and an inquisitive mindset
Good sense of organization, prioritization, adaptability
Excellent interpersonal and relational/oversight skills, team-player
Technical skills:
Ability to summarize scientific information and edit text for specific audiences
Comfortable with computer applications and ongoing innovations
Education:
- Scientific background (masters degree, or equivalent professional experience)
Language(s):
- Strong English skills (verbal and written), ability to exchange fluently in a global environment
Why choose us?
- Bring the miracles of science to life alongside a supportive, future-focused team in an international work environment
- Work from an "Office of the Year 2023" award winner with flexible home office policy
- Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact
- Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks gender-neutral parental leave
- An individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeks
- Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)
Pursue Progress. Discover Extraordinary.
Progress doesnt happen without people people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. Y