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The Technical Writer position is responsible for writing methods, protocols, reports, SOPs and evaluating compendia procedures as it impacts the pharmaceutical products or raw materials.
Manage medium and larger size projects and in collaboration with client and internal resources.
Work with department manager and schedule projects according to projects prioritization and work with groups and functions to manage resources efficiently.
Leading technical writer team for improvement initiatives and workload distribution.
Responsible for supporting the scientists in R&D to prepare the documentation as required by clients, including follow up of change controls, maintaining the templates for laboratory documents.
In addition, responsible for periodic review of the compendia changes and providing evaluation as it impacts the Raw Material, Finished Product and R&D groups within Analytical Operations.
Working with chemistry laboratory personnel, write or review reports for method development, feasibility, transfer verification and validation projects.
Working with chemistry laboratory personnel, write or review client methods for routine sample analysis as needed.
Review various lab documents.
Ensure timely review of compendia updates, such as USP, EP, JP.
Document and communicate the compendia changes to impacted departments.
Qualifications
Bachelors Degree
Masters in Science
3 to 5 years experience in a laboratory setting with Min 2 years of Pharmceutical Technical Writing