Located in beautiful Western Michigan between Grand Rapids and the shores of Lake Michigan, QST Consultations, LTD. is a full-service clinical research organization (CRO) providing full clinical operations, data management, statistical analysis support and medical writing services to the drug and device development industries. Founded in 1974, the company has collaborated with clients on many successful Phase I-III and Post-Marketing clinical trials designed to support 510(k), PMA, ANDA, and NDA submissions, along with ongoing marketing activity support. QST’s primary focus is to meet the goals of each client through personalized service and technical expertise; we currently work with a range of sponsors that extend from small start-up organizations to well-established leaders in the pharmaceutical industry.
As the company continues to grow, there is an incredible opportunity for a Manager of Medical Writing to lead medical writing activities and write NDA submissions, drug master files, PMA applications and registrations, in compliance with regulatory requirements. Our ideal candidate can be based anywhere in the US.
Are you ready to join the team?
You will be responsible for:
- Providing oversight and direction and performing Medical Writing activities, including quality and timeliness of product deliverables, process improvement, resource allocation, and coordinating training and development of personnel
- Serving as primary contact and/or program manager for medical writing aspects of projects and as member of management team
- Building and maintaining eCTDs, completing and tracking eCTD documents, and performing quality control on eCTD documents
- Mentoring and training employees
- Managing client expectations and preparing submissions to meet such expectations
- Participating in project meetings
- Performing gap assessments in regulatory documentation to ensure FDA requirements are met
- Have a master’s degree with at least six (6) years of relevant industry experience or a bachelor's degree and a minimum of eight (8) years of medical writing experience
- Have proven experience preparing clinical regulatory submissions and commitment to producing high quality documents that comply with internal and external standards
- Understand statistical analyses and be able to interpret and strategically present scientific and clinical trial data and results
- Have demonstrated problem-solving skills and be able to work simultaneously on multiple projects
- Be creative, collaborative, and communicative
Recognized as a top company to watch in Michigan, QST is a small employee-owned company that has been making a big impact in the CRO industry over the last 40 years. If you desire a rewarding career where you can make a difference, we encourage you to apply today!