Document Specialist

Company : Vcls

Job Type : Full Time

Bengaluru, India

Job Description - Document Specialist

Description

Format regulatory documents according to company and regulatory agency standards
Create and maintain document templates, style guides and formatting standards
Create and maintain submission-ready PDFs including Bookmarks, Hyperlinks, Table of Contents, page numbering, metadata etc.
Perform quality control (QC) reviews of regulatory documents before publishing and submission.
Ensure compliance with CTD/eCTD, NeeS, and eDok formatting requirements.
Support preparation of dossiers for submissions to agencies such as US FDA, EMA, MHRA, Swissmedic and Health Canada
Manage document life cycle activities, version control and archival
Coordinate with Regulatory affairs, medical writing, CMC, Clinical and Quality teams to obtain and process submission documents
Support Publishing teams during dossier compilation and submission activities
Maintain submission trackers, regulatory archives and document repositories
Monitor evolving regulatory submission standards and provide guidance to stakeholders
Participate in the update of internal eCTD Distinct Technical Procedures (DTPs)
Provide training and mentoring to document/eCTD Specialists (when applicable)
Interact frequently with clients during project execution and discuss/challenge as necessary
Proactively communicate with colleagues at all levels to ensure mutual exchange of information
Collaborate with all regulatory teams to ensure good coordination of activities and a coherent clinical program
Liaise with sponsor, regulatory authorities and/or service providers when appropriate
Raise awareness of potential opportunities regarding transversal activities (eg. for other Service Units and/or Areas of Expertise and/or Geographical Areas)
Proactively contribute to knowledge sharing within VCLS

Requirements

Life Science Graduate + solid academic background in Life Sciences;
Proven experience in document formatting, regulatory publishing or operations
Experience supporting eCTD, NeeS or eDok submissions
Knowledge of document management systems and quality-controlled environments
Strong knowledge of Microsoft word formatting
Experience in a consulting environment is a plus;
Good command of MS Office (Word, Excel, PowerPoint);
Excellent attention to detail and organizational skills
Strong problem-solving skills, ability to work under tight deadlines and manage multiple projects
Demonstrated ability to manage and build relationships with colleagues and regulatory authorities

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Document Specialist

Job Description - Document Specialist

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