A growing medical device company established in the US, is seeking a Senior Manager of Medical Writing to join them in New Jersey.
Deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications. The Senior Manager, Medical Writing is accountable for preparing clinical study reports and clinical summary documents, including, but not limited to, Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format. The responsibilities also include the coordination and preparation of Meeting Content Packages, responses to regulatory authorities as well as the management and preparation of a variety of clinical documents including patient narratives, and investigator brochures for Phase I to IV clinical trials. Competency in the use of document templates and Documentum (or a similar document management system) is required. Some knowledge of or experience with electronic publishing tools is desired.
- Prepare and coordinate high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA), responses to regulatory authorities in eCTD format as required. Incumbent interacts with multi-disciplinary team members (regulatory, physicians, statisticians, clinicians, data managers and drug safety group) as applicable. Generate project objectives, timelines, and documents, coordinate contributions from other groups, prepare the documents within the required templates, and pull together the documents in an efficient manner for submissions to regulatory authorities.
- Prepare and coordinate clinical documents as required, e.g., Clinical Trial Reports (Phase I - IV) with associated appendices, Investigator's Brochures, Clinical Expert Statements/ Addenda to Clinical Overviews for product renewals.
- Review medical documents generated outside of MW (e.g., Study protocol, Statistical Analysis Plan, Tables and Listings).
- Support preparation/review of Drug Safety related documents such as Periodic Safety Update Reports (PSUR/PBRERs), Development Safety Update Reports (DSURs), and Risk Management Plans ( RMPs)
- Prepare / review SOPs, Working Guides and document templates.
- B.S. degree required, Advanced degree in Life Sciences preferred.
- 7-10 years of experience in regulatory writing within the pharmaceutical industry, including managing global registration dossiers.
- Experience with diagnostic imaging agents preferred.
- Experience working with an electronic based document management system.
- Vendor/consultant management experience preferred.
- Experience working with regulatory affairs groups and formulating regulatory strategies desirable.
- Working knowledge of worldwide registration document requirements including ICH guidelines as well as EMEA and FDA regulatory guidelines and requirements.
- Demonstrated medical writing skills and a high level interpersonal ability to interact effectively in team and matrix work settings.
- Excellent written/oral communication skills and highly proficient word processing skills, including a familiarity with the use of document templates.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying, please upload your CV on our website www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.