Clinical Electronic Documentation Specialist

• Location: Budapest, Hungary
• Flexible working: 60% home 40 % office
• Job type: Permanent, Full time

About the job

Our Team:

The electronic Document Specialist (eDS) role operates within the Clinical Electronic Document Management (CEDM) subgroup of CSO-Clinical Documentation. The primary functions of the eDS role are as follows:

To ensure format and submission-readiness validation of clinical documents prepared in the official Sanofi electronic Document Management System (eDMS). Perform compilation/publishing of non-complex documents and implement navigation required to submit clinical Electronic Documents and Dossiers to Health Authorities.

The eDS works in close collaboration with Sanofi teams responsible for the operational delivery of clinical documents. This role works with internal members of Clinical Documentation, such as medical writers and record managers, as well as contributors from other functional areas, including (but not limited to) Regulatory, Pharmacology, Statistics, Clinical Leaders, and Project Leaders.

The eDS works in an environment in constant evolution and needs to be prepared to work with new technologies including Artificial Intelligence.

Main responsibilities:

• Perform format and submission-readiness validation of clinical documents Ensure that all Sanofi requirements are applied as per SOP and guidance

• Publish/compile clinical documents that consist of multiple components
• Create clinical documents in the Sanofi eDMS
• Ensure conformity of clinical documents (e.g., naming conventions, metadata within the eDMS)
• Set links within documents (internal)
• Publish/compile non-complex clinical documents as required
• Support projects for publish of Clinical Study Reports

• Review and confirm feasibility of publishing/compilation Microplans (timelines) provided by Sanofi Medical Writers
• Monitor the availability of appendices
• Follow-up with contributors
• Perform format and submission-readiness validation on appendices
• Compile all documents in the required/correct order
• Perform format and submission-readiness validation on the publishing/compilation

• Electronically approve, within the eDMS, all clinical documents

• Copy documents from Vault RIM to eTMF Vault Clinical

About you

• Experience:
• Pharmaceutical industry experience or related industry experience is preferred
• Document management experience is an advantage
• ⁠Experience of formatting electronic documents and or submission dossier experience is desirable
• Knowledge or experience with Artificial Intelligence (AI)

• Soft Skills
• Excellent verbal, written, organizational and interpersonal skills with an assertive and diplomatic approach, not afraid to ask for help as and when required
• Highly self-motivated, pro-active, open minded, responsible, and autonomous individual
• With a strong attention to detail and the ability to handle multiple tasks simultaneously
• Collaborative team player with orientation towards building and maintaining effective relationships with strong culture awareness
• Ability to work under pressure, adaptability to change, solve problems and willingness to learn to drive to meet short deadlines and shifting priorities
• Ability to work with multifunctional and multicultural teams in a matrix organization

• Technical skills:
• Strong appetite for digital and tech savvy individual
• Strong computer software skills and solid knowledge of MS Office 365 environment including advanced competency in MS Word (ability to format and work with features)
• Specific software tools desired, not mandatory: eDMS, publishing tools, Acrobat (ISI Toolbox)

• Education:
• Bachelor degree in life science or related is preferred

• Languages
• Strong Command of English in both verbally and in writing

When joining our team, you will experience

• An international work environment, in which you can develop your talent and realize ideas and innovations within a competent team
• An attractive, market-oriented salary and cafeteria benefits
• Flexible home office policy, with a possibility to work up to 60% of time from home / where you can easily schedule your office days
• Work from an "Office of the Year 2020" finalist office
• Collective life and accident insurance
• Yearly medical check-up
• 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
• Your own career path within Sanofi
• Your professional and personal development will be supported purposefully
• Join a great community & special events (Monthly Board Game Nights, Summer Events, Well-Being Lectures & Sport Clubs)

Pursue Progress. Discover Extraordinary.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.