Technical Writer II – AR&D
Technical Writer II – AR&D
Coordinates and performs a variety of technical AR&D writing projects. Coordinate technical liaison services within the R&D department, between Regulatory Affairs, Quality Analytical R&D, and other departments that may apply.
- Prepare draft methods of testing and analytical reports by researching Technical Packages, USP, EP, and/or BP.
- Responsible for initiation of change control processes and collaboration with Regulatory Affairs and Quality Assurance on the documentation requirements to support proposed change.
- Responsible for the preparation, revision and finalizing of analytical methods of testing and certificates of analysis.
- Work with AR&D management and teams, RA and QARD, to obtain approval for the appropriate documents and provide signed documents for use by AR&D.
- Ensure correct format and technical content including appropriate calculations.
- Review all analytical reports for accuracy and format.
- Work on the implementation of new electronic systems for ARD documents, MasterControl Documentation systems.
- In charge of the distribution, filing, and archiving of all AR&D notebooks.
- Work on developing Method validation protocols/reports templates, as well as reformatting all ARD documentations to be in compliance with ANDA submissions-eCTD Considerations posted by FDA
- Assist Lead Scientist in writing and revising Method Validation protocols/reports of analytical procedures, as well as ensuring compliance with SOPs and Industry practices/Guidelines.
- Work with lead scientist and/or management in writing and revising Standard Operating Procedures (SOP).
- Ensure complete and accurate documentation is prepared according to industry, FDA/ICH CMC guidelines, as well as establishing timelines for deliverables.
- Collaborate with lead scientists and Management to prepare appropriate Modules, QOS and other documents for ANDA submissions; such as standalone documents for drug substances, analytical method validation reports, summary stability reports, comparative dissolution reports, residual solvents justification reports, Elemental Impurities Risk Assessment reports, Extractables and Leachables reports and others, as required
- Assist Teams in timely documentation support for various FDA information requests, such as IR/CRL letters and during FDA inspections.
- Coordinates and performs a variety of technical AR&D writing projects
- Assist in special projects or other tasks as deemed necessary based on individual’s qualifications, business needs and laboratory operations management’s discretion.
- Other duties as assigned.
- 3-5 years of experience in the pharmaceutical industry with BS
- Experience with writing and editing technical documentation
- Excellent writing and communication
- Experience working in pharmaceutical industry and/or analytical laboratory is highly desirable
- Knowledge of Industry Guidelines, e-CTD submissions and ANDA submissions
- Good knowledge and experience in Finished Product (FP), Raw Material (API) and Excipient testing (Wet chemistry) including all Physical
- Maintains confidentiality
- Comply with all cGMP requirements and Company policies, procedures, rules and regulations
- Possesses sound documentation and writing skills
- Communicates effectively
- Demonstrates ability to prioritize conflicting demands
- Executes assigned tasks within established schedule
- Competency with MS Word and Excel
- Knowledgeable with MS Office
- Ability to work in a general office environment.