Document Specialist

For over 20 years, ProPharma Group has been a trusted partner in the biotech, medical device, and pharmaceutical industries, helping companies bring innovative therapies to market. With expertise in regulatory sciences, clinical research, pharmacovigilance, and compliance, ProPharma provides end-to-end consulting solutions. The company fosters a diverse, inclusive workplace where employees are encouraged to innovate and grow. If you're looking for a dynamic career in regulatory document publishing, this is your opportunity! Key Responsibilities: Format, review, and compile regulatory documents (Word & PDF) for eCTD submissions (IND, CTA, NDA, BLA, MAA). Ensure compliance with ICH E3/E6(R2), EU MDR/IVDR, and client-specific guidelines. Perform PDF conversions, adding bookmarks, hyperlinks, and keyword linking for regulatory compliance. Manage multiple publishing projects, ensuring timely and accurate submissions. Collaborate with clients and internal teams to resolve formatting and publishing issues. Conduct peer reviews and support process improvement initiatives.

For over 20 years, ProPharma Group has been a trusted partner in the biotech, medical device, and pharmaceutical industries, helping companies bring innovative therapies to market. With expertise in regulatory sciences, clinical research, pharmacovigilance, and compliance, ProPharma provides end-to-end consulting solutions.