Job Order: 5123
Staff Representative: Tim Jadwin
Position: Medical Writer/Sr. Medical Writer
Location: Illinois
Company Summary:
Our client, a large pharmaceutical company, is dedicated to serving patients by providing innovative products that improve their lives with better healthcare. With a foundation built on a robust, early-stage pipeline, our client is a world class pharmaceutical company.
Description:
We have an excellent opportunity for a Medical Writer at our corporate headquarters.
You will perform the following functions in this key role:
- Execute medical writing activities for projects in accordance with applicable US and international regulatory regulations and requirements under the supervision of the Manager, Medical Writing.
- Assume primary responsibility for preparation of regulatory response documents and documents supporting major regulatory submissions, under the direction of the manager.
- Participate on relevant project teams and task forces, and provide guidance to clinical, safety, nonclinical, and CMC functions on a wide range of issues related to document preparation and production, including US and international regulatory guidance and requirements for content and format, requirements (style, electronic integrity, and process), and project- or therapeutic area-specific guidance related to content and organization of specific documents.
- Prepare documents for submission to FDA or other regulatory agencies, in accordance with team input, with oversight from the manager.
- Provide review and substantive editing of contributions from external contract writers.
- Serve on teams and task forces, and provide guidance for document preparation and production to team members from other functional areas (nonclinical, safety, CMC, clinical).
- Participate on functional teams that address requirements or issues related to document preparation and production.
- Bachelor’s degree in science, health profession, or journalism.
- Minimum of 2-3 years experience writing for pharma or biotechnology or equivalent experience (eg, academia or scientific publications).
- Advanced degree in science, health profession, or journalism is preferred.
- Basic understanding of scientific methodology, with ability to understand clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission.
- Ability to understand FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs).
- Ability to understand guidelines and requirements related to the preparation and production of regulatory documents and submissions.
- Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within cross-functional teams and with external providers.
- Ability to identify issues and generate solutions or request appropriate intervention by management.
- Ability to drive to or fly to various meetings/client sites - limited overnight. Some international travel may be required. Less than 10% travel per year.
