Document Specialist

Company profile 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 affairs, clinical trial management, and market access, ProPharma has established itself as a trusted advisor to the life sciences industry. Our team of experts is dedicated to providing innovative solutions that help our clients navigate complex regulatory environments, optimize their product development processes, and bring new treatments to patients who need them most. We are seeking a highly motivated and detail-oriented Document Specialist to join our dynamic team. As a key member of our documentation group, you will be responsible for preparing and reviewing documents related to clinical trials, regulatory submissions, and market authorization applications. Your primary responsibilities will include: • Preparing and reviewing clinical trial protocols, informed consent forms, and case report forms; • Assisting in the development of regulatory submission packages, including INDs, NDAs, and 510(k)s; • Reviewing and editing documents for accuracy, completeness, and compliance with relevant regulations and guidelines; • Collaborating with cross-functional teams to ensure timely and effective document preparation and review. To be successful in this role, you will need to possess the following skills and qualifications: • Bachelor’s degree in a life sciences-related field (e.g., biology, chemistry, pharmacology) or a related field such as documentation, regulatory affairs, or clinical research; • 2+ years of experience in document preparation and review, preferably in the life sciences industry; • Strong understanding of clinical trial regulations, Good Clinical Practice (GCP), and relevant guidelines; • Excellent written and verbal communication skills; • Ability to work independently and as part of a team; • Proficiency in Microsoft Office, particularly Word and Excel. In return for your expertise and dedication, ProPharma offers a comprehensive benefits package that includes: • Competitive salary and bonus structure; • Comprehensive health insurance with medical, dental, and vision coverage; • 401(k) plan with company match; • Paid time off and holidays; • Professional development opportunities; • Collaborative and dynamic work environment. If you are a motivated and detail-oriented professional looking for a challenging and rewarding opportunity, please submit your application to join our team.