Technical Writer

Job Summary:

The Technical Writer will be responsible for creating, reviewing, and managing documentation related to pharmaceutical testing protocols and reports. This role involves overseeing the approval process of these documents and coordinating with Contract Manufacturing Organizations (CMOs) to ensure the timely and accurate execution of testing activities. The ideal candidate will have a strong background in technical writing within the pharmaceutical or biotech industry, excellent project management skills, and a keen eye for detail.

Key Responsibilities:

1. Writing and Documentation:
   • Develop, write, and revise pharmaceutical testing protocols, including stability, validation, and method development protocols, ensuring clarity, accuracy, and compliance with regulatory requirements.
   • Author comprehensive testing reports that summarize the results, analyses, and conclusions of pharmaceutical testing activities.
   • Ensure all documents meet the company’s style guidelines and are consistent with industry standards and regulatory expectations.
2. Approval Process Oversight:
   • Manage the review and approval process for testing protocols and reports, coordinating with internal teams such as Quality Assurance, Regulatory Affairs, and R&D to obtain necessary approvals.
   • Track the progress of documents through the review cycle, ensuring timely completion and addressing any issues or delays that arise.
   • Facilitate meetings and discussions to resolve any concerns or discrepancies during the review process.
3. Coordination with Contract Manufacturing Organizations (CMOs):
   • Act as the primary point of contact with CMOs for the execution of pharmaceutical testing activities.
   • Provide CMOs with the necessary protocols and instructions, ensuring they have all required information to perform the testing accurately and in compliance with regulatory standards.
   • Monitor the progress of testing at CMOs, addressing any issues or questions that arise and ensuring that timelines are met.
4. Regulatory Compliance:
   • Ensure all documentation complies with applicable regulatory standards, including FDA, EMA, and other global regulatory requirements.
   • Stay current with industry regulations and best practices, updating protocols and reports as necessary to maintain compliance.
5. Cross-Functional Collaboration:
   • Collaborate with cross-functional teams, including Quality Control, Quality Assurance, Regulatory Affairs, R&D, and external partners, to gather the necessary information for protocol and report writing.
   • Work closely with project managers to align document timelines with overall project schedules.
6. Document Control and Management:
   • Maintain organized records of all testing protocols, reports, and related documents.
   • Manage document version control and ensure that all stakeholders have access to the most current versions of documents.
7. Continuous Improvement:
   • Identify opportunities to improve the efficiency and effectiveness of the document creation and approval processes.
   • Contribute to the development and maintenance of standard operating procedures (SOPs) related to documentation and testing processes.