The Opportunity
A preeminent global pharmaceutical corporation seeks a Technical Writer on a long-term, temporary basis for at least twelve months, possibly longer in Exton, PA. The schedule is Monday - Friday, 8:00 a.m. - 5:00 p.m. and is hybrid, two - three days per week and may be subject to change. The hourly rate is $30 - $40, plus benefits.
Primary Duties
The Technical Writer should have a strong scientific background to support the Analytical Outsourcing team in the Biopharmaceutical Development sector. The Technical Writer will focus on authoring and reviewing technical documents, supporting regulatory submissions, and working cross-functionally to ensure high-quality documentation and data integrity. Additional duties include the following:
- Author and revise technical reports, SOPs, and policies
- Prepare and edit analytical method validations, study protocols/reports, and CMC documentation for regulatory submissions
- Draft and review deviations, investigations, change controls, and other quality records
- Coordinate with external vendors for testing and sample shipments
- Review and compile scientific data to ensure completeness and compliance
- Analyze stability data and support shelf-life assessments
- Utilize LIMS for protocol creation, data entry/approval, and trending
- Manage purchase orders, invoices, and vendor agreements; liaise with Finance to update budget forecasts
- Oversee the review, approval, and archiving of documentation
- Support laboratory testing activities as needed
Requirements
- Bachelor’s degree in Chemistry, Biology, or a related scientific field
- 2–3 years of hands-on laboratory experience, preferably in protein therapeutics or monoclonal antibody development
- Proven proficiency in scientific and technical writing
- Hands-on experience with Empower Chromatography Data System is REQUIRED
- Familiarity with GMP/GLP and regulated environments
- Strong written and verbal communication skills
- Excellent attention to detail and organizational abilities
- Proficiency in Microsoft Office tools, particularly Word, Excel, and SharePoint
- Advanced Excel skills (preferred)
- Experience with systems such as LIMS, SAP/SRM, TrackWise, and Veeva
The Partnership – Benefits
- ABA-MEC Medical Benefit
- PEP 401k
- Paid Time Off
- Employee Assistance Program (EAP), Working Advantage (Discounts), and Financial Wellness Program (FinFit)
Frink-Hamlett Legal Solutions is an equal employment opportunity employer and all applicants will receive consideration for employment without discrimination based on race, color, creed, national origin, sex, age, disability, marital status, sexual orientation or citizenship status.