- This company is committed to hiring veterans.
Senior Manager, Medical Writing
SUMMARY: 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.
ESSENTIAL DUTIES AND RESPONSIBILITIES: include the following:
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.
SECONDARY DUTIES AND RESPONSIBILITIES include the following:
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.
SUPERVISORY RESPONSIBILITIES: N/A
CORE COMPETENCIES: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the core competencies required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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.
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 in a team setting.
Team player adaptable to change, with excellent organizational skills, quality focused, with proven analytical and problem solving capabilities.
EDUCATION and/or EXPERIENCE REQUIRED:
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.
CERTIFICATES, LICENSES, REGISTRATIONS: N/A
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Occasional travel may be required (less than 10%).
WORK ENVIRONMENT: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The position is office based.
Teams within the Global Medical and Regulatory Affairs department: Executive Medical Leaders, Clinical Research, Data Management, Biostatistics, Drug Safety and Pharmacoepidemiology, Regulatory, Preclinical Research
External Medical Writing Vendors (Individual consultant writers and CROs)