OVERVIEW
We are currently searching for a skilled professional to join a well-known client’s team as a Technical Writer in Exton, PA. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
• Author technical reports, policies, and Standard Operating Procedures.
• Author/review, format, and revise reports, protocols, analytical method validations, and CMC sections for regulatory submissions.
• Author investigations, deviations, change controls, and other non-conformance records.
• Work with vendors to coordinate testing and arrange shipments as needed.
• Compile and review scientific data for completeness as needed.
• Perform trending and evaluation for continuous monitoring of stability data and shelf-life extension.
• Use of LIMS database including protocol setup, data entry/approval, and data trending.
• Process invoices, purchase orders, and other agreements. Interact with finance and vendors to confirm work and adjust budget forecasts.
• Coordinate document review, approval, and archiving.
• Participate in analytical testing lab activities, on an as needed basis.
EXPERIENCE
• At least 2-3 years scientific/analytical lab experience, preferably in the field of protein therapeutics or monoclonal antibody therapies.
EDUCATION
• BS in Chemistry, Biology or a related scientific discipline.
To be a best-fit your strengths must include:
• Experience in Empower chromatographic data system
• Experience with LIMS, SAP/SRM, TrackWise, and Veeva.
• Excellent oral communication, interpersonal and technical writing skills.
• Excellent organizational skills, demonstrate attention to detail.
• Experience in GMP/GLP and/or a regulated industry.
• Strong background in Microsoft applications such as Word, Excel, SharePoint a must.
• Advanced Excel knowledge is a plus.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.