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.

• Education: Bachelor’s degree in a scientific discipline (e.g., Chemistry, Biology, Pharmaceutical Sciences) or a related field. Advanced degree preferred.
• Experience:
  • 3+ years of experience in technical writing within the pharmaceutical, biotech, or related industry.
  • Experience writing protocols and reports for pharmaceutical testing, including stability studies, method validation, and quality control.
  • Familiarity with regulatory requirements for pharmaceutical testing documentation (e.g., FDA, EMA guidelines).
• Skills:
  • Exceptional writing and editing skills, with the ability to convey complex scientific information clearly and concisely.
  • Strong project management skills, with the ability to manage multiple projects and deadlines simultaneously.
  • Excellent interpersonal and communication skills, with the ability to collaborate effectively with internal and external teams.
  • Detail-oriented with a strong commitment to accuracy and quality.

Preferred Qualifications:

• Experience coordinating with Contract Manufacturing Organizations (CMOs) or other external partners.
• Familiarity with electronic document management systems (EDMS).
• Understanding of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).

Working Conditions:

• Office-based position with occasional travel to CMOs or other partner sites as required.
• Flexibility to work with teams across different time zones.