Welcome to PPD-Pharmaceutical Product Development, a leading global contract research organization dedicated to helping our clients advance medical treatments and improve the lives of patients around the world. We are currently seeking a highly skilled Senior Document Review Specialist to join our team. In this role, you will play a critical role in ensuring the accuracy and completeness of… essential clinical trial documents, supporting the development of life-changing therapies. Our ideal candidate has extensive experience in document review and a strong attention to detail, along with the ability to work collaboratively in a fast-paced, dynamic environment. If you are passionate about making a difference in the pharmaceutical industry and possess the necessary qualifications, we invite you to apply for this exciting opportunity.
Review and verify the accuracy and completeness of essential clinical trial documents, including but not limited to informed consent forms, study protocols, and investigator brochures.
Collaborate with cross-functional teams to ensure consistency and compliance with regulatory requirements, company standards, and industry best practices.
Conduct quality checks and provide feedback on documents to ensure they meet company standards and are ready for submission to regulatory authorities.
Implement document control procedures to ensure version control and proper archiving of documents.
Maintain a thorough understanding of relevant regulations and guidelines, including ICH-GCP and FDA guidelines, to ensure document compliance.
Communicate any document discrepancies or issues to relevant team members and work with them to resolve in a timely manner.
Develop and maintain document review templates and checklists to ensure consistency and efficiency in document review processes.
Train and mentor junior document review specialists on document review processes and standards.
Participate in audits and inspections, providing necessary support and documentation as needed.
Continuously evaluate and improve document review processes to increase efficiency and accuracy.
Collaborate with cross-functional teams to identify and implement new technologies or tools to streamline document review processes.
Maintain confidentiality and security of all documents and information.
Adhere to company policies and procedures, as well as relevant regulations, at all times.
Participate in departmental meetings and contribute to process improvement initiatives.
Stay up-to-date on industry trends and developments related to document review and suggest improvements to current practices.
PPD-Pharmaceutical Product Development is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics
