Sr. Manager, Medical Writing Job Description:"Growing Pharmaceutical Company located in Princeton, NJ is seeking for a Sr. Manager, Medical Writing to join their organization"
Duties and Responsibilities:
-Serve as the medical writing (MW) representative on Project Teams.
-Provide input to the development of strategy for multinational clinical activities associated with registration and market support of a product.
-Review medical documents generated outside of MW (e.g. Study Protocols, Statistical Analysis Plans, Tables and Listings).
-Prepare/coordinate clinical documents as required (e.g. Clinical Trial Reports (Phase I – IV) and associated appendices, Investigator’s Brochures, Periodic Safety Update Reports, Annual Safety Reports, Ad Hoc Safety Reports, clinical sections of IND/IMPD/NDA/MAA/CTD). Resolve conflicting comments among reviewers and collate comments for submission to consultants/CRO as necessary.
-Prepare/coordinate clinical sections of submission (IND/IMPD/NDA/MAA//CTD) and responses to regulatory authorities, and implement medical writing activities. Interact with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians, data managers and drug safety group) as applicable. Discuss the objectives, timelines, and documents to be generated; coordinate contributions from other groups and pull together the documents in a efficient, non-disruptive manner for submissions to regulatory authorities.
-Manage the activities of internal/external resources and medical writing vendors (i.e. individual consultant medical writers and contract research organization (CRO) medical writers).
-Prepare/review SOP’s and document templates.
-Manage projects within pre-defined budget, pre-defined internal resources and time constraints
-Providing status reports for ongoing projects
-Demonstrated medical writing skills and high level interpersonal skills to interact effectively within team and matrix work settings. Sensitivity to cultural differences.
-Excellent written/oral communication skills and highly proficient word processing skills.
-Working knowledge of worldwide registration document requirements including ICH guidelines, EMEA requirements and FDA guidelines and requirements.
-Ability to multi-task, deal with competing priorities, meet aggressive timeline expectations.
-Ability to think clearly, get appropriate input from different disciplines as needed, provide focused answers.
-Team player who is cost conscious, adaptable to change, excellent organization skills, quality focused, with proven analytical and problem solving abilities.
Education and/or Experience Required:
-B.S. degree, advanced degree/Life Sciences preferred.
-7-10 years experience in regulatory writing or equivalent within the pharmaceutical industry, including managing 2-3 global registration dossiers
-Experience with contrast medical and imaging modalities preferred.
-Experience with an electronic based document management system.
-Vendor/consultant management experience preferred
-International travel, generally to European countries required, approx. 15%.
MEDICAL WRITING, PHARMACEUTICAL MEDICAL WRITING
Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.