Technical Writer

Pharmica | U.S. Only | 4 months ago

UnknownUnknownAdvanced (5-10 years)Advanced (5-10 years)Long-termLong-termUnknownUnknown

Pharmica is seeking a driven and detailed Technical Writer for a 6 month contract. This position will be responsible for collaborating with other team members and support the project team. The Technical Writer position will be fully remote.

Responsibilities will include, but not be limited to, the following:

Write and update Module 3 (drug substance and drug product quality sections) of the CTD/NDA Application for solid orally administered product based on data collected by Technical Services team
Work with existing team of scientists and pharmacists that developed the formulation process & control process
Support and advise the project team regarding pharmaceutical development related to regulatory strategy for submission
Perform some basic data mining, generate the data, convert to technical reports, and input into the module
Gather and review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation and prepare such data outputs
Facilitate key message and document review meetings and discussions
Review documents for submission-readiness
Work will be performed in compliance with ICH Guidelines
Prepare the answers to the CMC questions raised by the Health Authorities following the submission of Marketing /Clinical Trial Applications and technical variations
Maintain on-going communication with all stakeholders for all project related activities and tasks supporting the quality department globally
Other tasks as assigned by Director of Technical Services
All work will be reviewed and approved before submission
Experience:

10+ years of experience working as a Technical Writer in the Pharmaceutical industry
Bachelor’s degree in a scientific field
Experience working in Module 3
Knowledge of the ECTD and the sections that exist in Module 3
Process Development experience preferred