Document Specialist

The Document Specialist will support Regulatory and submission teams to enable electronic regulatory submissions to authorities worldwide. The role ensures assigned documents are completed in high quality, Ready For Submission (RFS) format within agreed timelines, in collaboration with authors and in coordination with Regulatory publishing as needed.

The Document Specialist utilizes the electronic Document Management System and related tools to support document readiness within assigned programs. The role also provides training, coaching, and guidance to technical authors, R&D teams, and CRO partners on document standards, tools, and system use to promote consistency in processes and practices.

WHAT - Main Responsibilities & Technical Competencies

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

• Ensure appropriate training, coaching and mentoring to the users, including those in CROs to ensure documents are created, authored, reviewed and approved according to relevant standard operating procedures (SOPs) or guidelines and that technical standards of final approved documents are compliant with RFS requirements.
• 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
  
  

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.
  
  

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
  
  

HOW - Knowledge & Experience

Knowledge & Experience (essential):

• 5 years of experience as a Document Specialist within a CRO or pharmaceutical environment
• Strong interest in leveraging and implementing new technical tools
• Flexible and adaptable, with the ability to reprioritize and work effectively under pressure
• Excellent time management skills, with the ability to forecast and manage workload effectively
• Experience with eDMS, Microsoft Word, PDF tools, and hyperlinking tools (e.g., ISI Toolbox)
• Solid understanding of document management best practices and Good Clinical Practice (GCP)
• Experience with eDMS and authoring tools, ideally Veeva Vault
• Proficiency in Microsoft Office applications (Word, PowerPoint, Excel) and Adobe Acrobat
  
  

Knowledge & Experience (preferred)

• Experience within a pharmaceutical environment (vs CRO) would be advantageous
  
  

Education / Certifications (essential)

• Bachelor’s degree in Life Sciences, Medicine, Pharmacy, or a related discipline.
• Candidates with an Associate degree may be considered with relevant experience
  
  

Education / Certifications (preferred)

• Advanced degree (MSc or PhD) in a relevant discipline is a plus.
  
  

Language(s) (essential)

• Fluent in English.
  
  

Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.

All Employees are expected to adhere to all company policies and act as a role model for company values.

The annual base salary range for this position is from $91,500-$134,200.

This job is eligible to participate in our short-term incentives program.

At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.

The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills