Description
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 robust background in technical writing within the pharmaceutical or biotech industry, excellent project management skills, and a keen eye for detail.

Key Responsibilities:
- 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.




- 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.
- 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

📌 Technical Writer (Kukatpally)
🏢 Aveva Drug Delivery Systems
📍 Kukatpally