Document Specialist

Company profile

For the past 20 years, Pro Pharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), Pro Pharma partners with its clients through an advise-build-operate model across the complete product lifecycle.

With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, Pro Pharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The role
The Document Specialist position is responsible for formatting, reviewing compiling, and processing regulatory documents (both Word and PDF) in support of electronic publishing activities with a focus on quality, accuracy, and efficiency providing publishing support to Pro Pharma clients.

Essential Functions:

Directly supports electronic submission of regulatory documents / applications including IND, CTA, NDA, BLA, MAA, etc. through formatting, processing, and compilation of Word and PDF documents to the appropriate client specifications.
Formats and reviews Word documents in preparation for publishing, in accordance with all relevant client style guides and / or regulatory guidelines and specifications and within all established timelines.
Performs document conversion to PDF, and formats and reviews PDF documents to specification (for eCTD compliance), including bookmarks, hyperlinks, keyword linking, document properties, etc., in accordance with all relevant client style guides and / or regulatory guidelines and specifications and within all established timelines.
Compiles regulatory documents / reports, gathering all required documents, within all established timelines.
Publishes regulatory documents according to all relevant guidelines and specifications for eCTD submission, performing all relevant pre- and post-publishing quality review checks.
Prepares and transfers final documents for publishing, supporting client and internal team during submission preparation, routing documents for review and approval, where applicable.
Adheres to established regulatory standards / guidelines including but not limited to: ICH E3 / E6(R2) / M4, EU MDR / IVDR, Company standard operating procedures, and client standards instructions.
Supports multiple publishing activities / projects simultaneously and manages own workload, ensuring completion of all projects within established timelines, immediately escalating any issues.
Manages client expectations and interacts and communicates directly with clients to ensure accuracy and maintain timeline integrity.
Performs peer / quality review of documents processed by other team members as requested.
Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to document publishing.
Brings issues and potential concerns to line manager / client oversight manager’s attention in a timely manner.
Participates in departmental initiatives (e.g., process improvement, lunch and learns, etc.).
May occasionally be required to work outside of normal business hours to support client’s needs.
Other duties as assigned.

Key skills required:
Minimum 3 years of experience in document publishing and / or formatting.
Pharmaceutical / biotech industry experience (specifically, INDs / CTAs, NDAs / BLAs / MAAs) preferred.
Other professional and/or educational experience may contribute toward these minimum requirements, as determined on a case-by-case basis.
Fluency in English

Other key attributes desired:
Extensive knowledge and mastery of Microsoft Word (advanced level formatting).
Extensive knowledge and experience with Adobe Acrobat and plug-in tools, Regulatory Document and Information tools, and eCTD publishing systems (e.g., ISI Toolbox, Core Dossier).
Excellent problem-solving skills, including the ability to think outside the box.
Ability to work on multiple projects…