Location: Aspen Hill, MD
Position Title: Scientific Technical Writer
Citizenship: US Citizen or Green Card Holder
- Minimum of a Bachelors degree
- Will work on-site. May be open to a couple days of remote, but the more on-site the better.
The technical writer will collaborate closely with the manager, initiating, drafting, and preparing the first draft of assigned documents on SOPs, batch records, technical reports, specification, change control, deviation, root analysis, and CAPA in the GMP campaign.
Essential Duties & Responsibilities
- Provide editorial support, ensuring quality of all scientific content, with a focus on clarity, accuracy, and consistency while maintaining adherence to proper formatting and regulatory requirements
- Author and assist in technical transfer documentation and detailed process descriptions, SOPs, batch records, and campaign summary reports
- Initiate and manage multiple rounds of document review and ensuing revisions by proactively interacting with all levels of reviewers from SME to senior management
- Create and execute protocols that support technical transfer and GMP manufacturing
- Perform documentation gap analyses and develop plans for writing requirements.