Advanced Clinical is hiring : Technical Writer in Exton

Overview

We are currently searching for a skilled professional to join a well-known client’s team as a Technical Writer in Exton, PA. The Technical Writer role requires strong technical writing skills combined with hands-on expertise in Empower software. They must have demonstrated experience in configuration, method / report creation, and custom calculations. 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

Minimum of 2-3 years scientific / analytical lab experience, preferably in the field of protein therapeutics or monoclonal antibody therapies

Education

Minimum of Bachelor’s Degree in science or a related discipline required

To Be a Best-fit Your Strengths Must Include

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.

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