Document Specialist Lead H/F

Title:

Document Specialist Lead H/F

Company:

Ipsen Biopharm Ltd

Job Description:

Summary / purpose of the position

• To lead the document specialist team to provide consistently high-quality documentation for submission to regulatory authorities across all therapeutic areas in R&D within agreed timelines.
• To ensure resources are available to manage all documents and new asset integration are adequately planned and performed withing agreed timelines and budget.
• To ensure the appropriate use of the electronic Document Management System (eDMS) and other tools in ensuring RFS status of documents intended for submission, within assigned programs.
• To provide training, coaching and mentoring for technical authors in R&D and other end users including those in CROs in document technical standards, use of tools and eDMS and harmonize process and practices.
• To apply project management expertise and contribute to functional excellence through people and process management.

Main responsibilities / job expectations

Manage Document Specialist Team:

• Provide expertise and mentoring to the Document Specialists on a day-to-day basis
• Lead the document specialist team and provide strategic directions to deliver to the highest quality and regulatory standards 

Support to the eDMS and Authoring tool users, as detailed below:

• Ensure appropriate training, coaching or mentoring to the users to ensure documents are created, authored, reviewed and approved according to relevant standard operating procedures (SOPs) and guidelines.
• Daily support authors with Word, authoring tool and eDMS to create, write and manage RFS documents
• Binder management in the eDMS for clinical and nonclinical functions (=multi component packages)
  • Create
  • Ensure that all eDMS properties (metadata) are completed; assist users to complete eDMS properties for corresponding documents.
  • Organise appendix development meetings and track progress against timelines
  • Ensure hyperlinks between documents are created where required
  • Manage binder until approval, including relevant workflows
  • Include clinical and nonclinical binders within relevant Regulatory Submission binder(s)
• Check documents are RFS. Repair documents when necessary, and feed-back to authors in order to limit issues in the future.
• Ensure correction of format or architecture errors identified by Regulatory Publishing in documents/binders for incorporation in submissions
• Attend and contribute to relevant team meetings covering assigned projects.
• Support R&D in the application of the good scanning practices.
• Coordinate, set, update and communicate the templates required for relevant documents.
• Coordinate, communicate and where necessary assist in updating the relevant SOPs.
• Collect and centralize any issues and requests from the users of authoring tool and eDMS. Participate in improvements of the processes and eDMS collaborating with the relevant groups.
• Develop knowledge of eDMS, eCTD and associated tools as used for the preparation of submission documents.
• Ensure business support for testing and implementing the upgraded eDMS and authoring tool.
• Support inspection readiness by filing TMF documents as per relevant SOPs, as needed

Provide support for the Legacy documents:

• Assist in identifying, locating, organizing the documents to upload into eDMS, if necessary.
• Identify any need for reformatting the currently available documents.
• Responsible for reformatting the appropriate documents.
• For company acquisitions or licensed assets, as requested, provides subject matter expertise in effective integration planning, implementation and monitoring of integration activities within the CDO integration team in collaboration with CDO integration Lead.

Communication

• Manage the communication of the final (submitted & approved) regulatory documents in order to take appropriate subsequent actions.
• Work collaboratively with the team to ensure deadlines are met, and effectively communicate when support may be required to meet them
• Work proactively to share expertise and knowledge, and improve processes and systems

EHS responsibilities:

• Comply with applicable EHS regulations and procedures.

• Participate in the site's EHS performance by reporting risks, malfunctions or improvements
• Participate in mandatory EHS training

Knowledge, abilities & experience

Education / Certifications:

• Minimum of associate degree in life sciences, medicine, pharmacy or equivalent

Experience:

• Minimum 5 years Document Specialist experience in either a CRO or pharmaceutical or biotech company
• Management experience or Project Team management is desirable.
• Proficient in using Microsoft Office (e.g. Word, PowerPoint, Excel) and adobe acrobat
• A keen interest in using and implementing new technical tools e.g. Articial intelligence.
• Flexible approach to working, with the ability to reprioritise and work under pressure when needed.
• Excellent time management skills and demonstrated ability to forecast and manage workload.

Languages:

• Have an excellent command of the English language in both written and verbal communications.

Key Technical Competencies Required

• In-depth knowledge and experience of Microsoft Word, PDF, hyperlinking tools (e.g. ISI Toolbox)
• Have a knowledge of good document management practices and good clinical practices
• In-depth knowledge and experience of eDMS and authoring tool Veeva Vault

#LI-Hybrid

#LI-Remote

#LI-Remote

#LI-MC1

IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.