For the past 20 years, ProPharma 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), ProPharma 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, ProPharma 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.
ProPharma Group focuses on providing program management and execution-based consulting within the life science industry. The Senior / Document Management Specialist is responsible for processing study documentation in accordance with Standard Operating Procedures (SOPs), Regulatory requirements, ICH and GCP guidelines and study specific TMF plans. This position reports to the Vice President, Clinical Operations, or designee.
Key Responsibilities
Support Trial Master File (TMF) set-up, maintenance, update, archival and
closeout (if applicable) in accordance with company SOPs, sponsor requirements, and applicable regulations.
- Reviews, edits, formats master documents according to approved procedures and templates, maintains document properties (metadata), monitors document status and approval notifications, distributions, and archiving.
- Conduct detailed and appropriate quality checks (QC) on TMF documents at defined time points, including any paper originals required.
- Ensure that privacy and security standards are met and adhered to. Ensure that documents are maintained in accordance with retention practices.
- Assist in routine internal and external master file audits to ensure compliance with applicable work instructions, Standard Operating Procedures (SOPs), Regulatory requirements, ICH and GCP guidelines.
Education & Experience
- Bachelor’s degree is preferred, however, candidates without a formal degree but who have comparable depth and breadth of training and experience and who meet job-specific criteria are eligible for consideration.
- Minimum 3 years of experience in Document Control, Quality Assurance or relevant work experience in the Biotechnology or Pharmaceutical industries or relevant, regulated environment for Document Management Specialist role; >5 years required for Sr. Document Management Specialist role.
- Proficiency in working with Electronic Document Management Systems; Veeva Vault experience is a plus
- Exhibits a good understanding of general quality assurance concepts and practices
- Highly organized with a strong attention to detail
- Proficiency in web-based systems and project management applications (e.g., Microsoft Office, SharePoint, etc.)
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
What We Do
ProPharma is the premier Research Consulting Organization (RCO), delivering fully customizable consulting solutions to empower biotech, med device, and pharmaceutical organizations of all sizes to advance scientific breakthroughs confidently and introduce new therapies.
With over 20 years of expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma partners with clients across the complete product lifecycle through an advise-build-operate model. Our end-to-end suite of consulting solutions de-risk and accelerate high-profile drug and device programs, ultimately improving patient health and safety. Discover how ProPharma can help you inspire the future of science
