Senior Document Review Specialist
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.
Extensive Experience In Document Review: The Ideal Candidate For A Senior Document Review Specialist At Ppd Should Have A Deep Understanding Of Document Review Processes And Protocols. They Should Have A Minimum Of 5 Years Of Experience In A Similar Role Within The Pharmaceutical Or Clinical Research Industry.
Strong Knowledge Of Regulatory Guidelines: Ppd Works With Numerous Clients And Must Adhere To Strict Regulatory Guidelines For Document Review. The Candidate Should Have A Thorough Knowledge Of Relevant Regulations Such As Fda, Ich, And Gcp Guidelines.
Attention To Detail: As A Senior Document Review Specialist, The Candidate Will Be Responsible For Reviewing And Verifying Complex Documents. The Ability To Pay Close Attention To Detail And Identify Any Errors Or Discrepancies Is Crucial For This Role.
Excellent Communication Skills: The Candidate Should Possess Strong Written And Verbal Communication Skills To Effectively Communicate With Cross-Functional Teams. They Should Also Be Able To Provide Clear And Concise Feedback On Document Review Findings.
Team Management Experience: The Senior Document Review Specialist May Be Required To Manage A Team Of Document Review Specialists. Prior Experience In Team Management And The Ability To Delegate Tasks, Provide Guidance, And Resolve Conflicts Is Highly Desirable For This Role.
Quality Assurance
Communication Skills
Project Management
Data Analysis
Time Management
Attention to detail
GMP Knowledge
Teamwork
Regulatory compliance
Problem-Solving
Document Review
Communication
Conflict Resolution
Leadership
Time management
creativity
self-motivation
flexibility
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Document Review Specialist is $50,000 to $80,000 per year. This can vary depending on factors such as location, experience, and the specific industry the specialist is working in. In some cases, Senior Document Review Specialists may earn up to $100,000 per year or more. It is important to note that these figures are estimates and may vary based on individual circumstances.
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PPD, Inc. is a global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services.
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