Documentation Specialist II

Title: Documentation Specialist II- Regulatory
Location: Morristown, NJ- REMOTE
Duration: 6 Months+ Possible Extension
Pay Range: $32/hr- $39/hr

• Remote
• Must have strong experience in adobe acrobat Pro, Veeva RIM (document management system for Regulatory)
• eCTD (common technical document) exposure and Strong Word Formatting

• Create and format documents, dossiers (including binders of authoring documents), reports, and perform submission-readiness validation according to regulatory guidelines and requirements for inclusion or not into the submission related activities (e.g. eCTD).
• This includes ensuring consistency in formatting, adherence to document templates, and compliance with Client standards.

• Ensure that all documents meet the specifications outlined for electronic submissions (e.g. INDs, CTDs), including file formats, naming conventions, and metadata requirements.

• Conduct formatting quality checks on documents to ensure accuracy, completeness, and compliance with Client standards, including reviewing documents (e.g. linking errors, inconsistencies) and making necessary revisions.

• Collaborate with cross-functional teams, including regulatory affairs, nonclinical (including Research), clinical development, quality assurance, CClient, ITS and other stakeholders, to gather the necessary information and documents for ensuring submission-readiness of the documents

• Manage electronic documents throughout the document preparation process, including version control (e.g. locked documents, embargo), tracking changes, and ensuring document integrity and security by using document management systems or other electronic tools to organize and maintain documents.
• In case of new company acquisitions, support document migration to Client electronic document management system.

• Maintain accurate and detailed records of document preparation activities, including documentation of any changes, revisions, or approvals made to documents during the submission-related activities.

• Document compilation and report publishing, ensuring compliance with regulatory requirements and company standards.

• Monitor regulatory updates and changes to ensure ongoing compliance with evolving electronic documentation requirements and standards including staying informed about new guidelines, best practices, and technological advancements in electronic submission processes.
• Keep abreast of current regulatory intelligence and industrial best practices

• Provide training and support to internal teams on submission readiness document preparation guidelines, and best practices to help ensure consistency and efficiency in document preparation across the organization.

• Identify opportunities for process improvements and efficiencies in document preparation and submission-readiness processes, including proposing and implementing changes to streamline workflows, enhance quality, or reduce errors.

• Strong experience in electronic document management within the pharmaceutical industry, with a focus on regulatory submissions for clinical trials and registrations (e.g. CTDs) exposure to formatting and report publishing requirements for Module 1 through Module 5.
• Strong understanding of regulatory requirements and guidelines governing pharmaceutical submissions (e.g., FDA, EMA).
• Soft, digital and technical skills:

• Understanding of regulatory information management Vault RIM systems, mastery of document management software and tools, such as electronic document management systems (EDMS), Adobe Acrobat, Microsoft Office Suite, and other relevant software used for document preparation and submission.
• Understanding of eCTD structure and specifications, including knowledge of XML tagging, metadata requirements, and file formats for electronic submissions.
• Ability to troubleshoot technical issues related to document formatting, conversion, and document preparation processes

• Strong attention to detail is essential for ensuring accuracy and completeness in document preparation and compliance with regulatory requirements.
• Ability to meticulously review documents for errors, ensure consistency, and compliance with formatting guidelines and naming conventions.
• Skill in maintaining version control and tracking changes to documents throughout the document preparation process to ensure document integrity.

• Familiarity with regulatory guidelines, standards, and requirements relevant to electronic document management and submissions in the pharmaceutical industry.
• Understanding of regulatory processes and documentation requirements for different stages of drug development, including INDs, NDAs, BLAs, and other regulatory submissions.
• Awareness of evolving regulatory trends, updates, and best practices related to electronic submissions and document management.
• Keep abreast of current regulatory intelligence and industrial best practices

• Effective communication skills to collaborate with cross-functional teams, including regulatory affairs, nonclinical (including Research), clinical development, quality assurance, ITS, CClient, and other stakeholders involved in document preparation and submission processes.
• Ability to convey technical information clearly and concisely to non-technical stakeholders and provide support and guidance on document management and submission-related queries. Fluency in English, both written and spoken
• Skill in building positive working relationships and facilitating teamwork to achieve common goals related to regulatory submissions.

• Strong problem-solving skills to troubleshoot issues and find solutions related to document formatting, conversion, and submission challenges.
• Ability to adapt to changing regulatory requirements, technology updates, and organizational processes, while maintaining quality and compliance in document management and submission-related activities.

• Bachelor s degree or equivalent degree in regulatory affairs, IT, sciences, related areas of study, and/or relevant experience

• Communicate effectively in English (spoken and written)