Job title: Trial Disclosure Manager

Location: Budapest

Flexible working: 60% home, 40% office

Job type: Permanent, Full-time
 

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.

Join our global Clinical Sciences and Operation (CSO)’s Clinical Documentation department as a Trial Disclosure Manager (TDM) and you’ll ensure timely public disclosure of protocol information and study results, in line with regulatory requirements and Sanofi data sharing commitments.

High attention to detail is needed due to externalization of company information and commercial sensitivity during product development, with strong summarizing skills. 

You will interact closely with clinical, statistics, regulatory, medical marketing, patents, and pharmacovigilance colleagues, to get the best solutions to specific public disclosure challenges on behalf of Global Business Units while ensuring timeliness and quality of deliverables. The working environment is undergoing constant evolution, and you can work with newest technologies.

Main responsibilities:

Work with colleague TDMs, study and/or project teams in order to plan, prepare, and release registrations and results on specific website/s within the required timelines.  You will also participate or lead activity in related process areas such as redaction of documents, preparation of summaries and management of public queries.Collaborate with colleagues and teams to drive resolution of specific disclosure challenges that may arise during product development and/or in relation to therapeutic specificities.Identify and follow-up CAPA in the event of deviations, for the assigned therapeutic or product areas.Supervise consultant and/or vendors on selected disclosure activity, ensuring in partnership the timely production of high-quality deliverables for Global Business Units or other Customers.Participate, contribute or lead selected quality, technical, and/or process-driven activities to ensure complete and timely follow up of the defined deliverables.Train or participate in delivery of selected training of colleagues, or Vendor, and similar communications.Have or develop knowledge of disclosure regulations, website standards, and company commitments / policy, and apply them to guide study, project teams, and colleagues.

About you

Experience:

Understanding of or exposure to the clinical development environmentClinical background, medical writing or regulatory submissions background will also be consideredStudy management, clinical research or related skills desired although not essential

Soft skills:

Ability to summarize scientific information and edit text for specific audiencesQuality consciousness, attention to detail, and an inquisitive mindsetComfortable with computer applications and ongoing innovationsGood sense of organization, prioritization, adaptabilityExcellent interpersonal and ‘relational/oversight’ skills, team-player

Technical skills:

Good knowledge of MS Office Suite (Word, Excel, PowerPoint)Comfortable with computer applications and ongoing innovations

Education: Scientific life science or related background (master’s degree, PhD or equivalent professional experience)

Languages: With excellent English, to support efficient decision-making

Why choose us?Bring the miracles of science to life alongside a supportive, future-focused team in an international work environmentWork from an "Office of the Year 2023" award winner with flexible home office policyEnjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impactTake 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 leaveAn individual and well-structured introduction and training of new employees and we will dedicate a Buddy for you to better navigate in your first weeksJoin a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)Pursue Progress. Discover Extraordinary.

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. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let’s pursue progress. And let’s discover extraordinary together.

At Sanofi, we provide equal opportunities to all regardless of race, color, 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!

Discover our Code of Conduct, that serves as the moral compass that guides us when chasing the miracles of science to improve people’s lives. Please ensure to have read this document before applying.

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#clinicalsciences #clinicaldocumentation #trialtransparency #trialdisclosure

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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, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!