Summary
In this on-site position, the Senior Manager, Medical Writing, is expected to deliver high-quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects. The "hands-on" Medical Writer is responsible for preparing 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, and responses to regulatory authorities as well as the management and preparation of a variety of clinical documents including clinical study reports, narratives, investigator brochures for Phase I to IV clinical trials, and drug safety related documents such as Periodic Safety Update Reports. Competency in the use of Documentum (or a similar document management system) is required, while some knowledge or experience with electronic publishing tools is desired. Reports to Executive Director, Corporate Medical Biometrics and Medical Writing.
Essential Duties and Responsibilities
Prepare/coordinate and deliver high quality clinical sections of submission (IND/NDA/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 do the needed writing and pull together the documents in an efficient, non-disruptive manner for submissions to regulatory authorities.
Prepare/coordinate clinical documents as required (e.g., Clinical Trial Reports (Phases I - IV) and associated appendices, Investigator's Brochures, Periodic Safety Update Reports, Annual Safety Reports, Ad Hoc Safety Reports, Clinical Expert Statements, clinical sections of IND/NDA/CTD). Resolve conflicting comments among reviewers and collate comments for submission to consultants/CRO, as necessary.
Manage the activities of internal/external resources and medical writing vendors (i.e., individual consultant medical writers and contract research organization (CRO) medical writers).
Manage projects within predefined budget, predefined internal resources, and time constraints.
Education and/or Experience
BS degree, advanced degree/Life Sciences preferred.
7 to 10 years of experience in regulatory writing within the pharmaceutical industry, including managing 3-4 global registration dossiers.
Experience with diagnostic imaging agents preferred.
Experience working with an electronic based document management system.
Vendor/consultant management experience preferred.
Experience with interactions with regulatory groups and formulating regulatory strategies desirable.
Core Relationships
Teams within the Global Groups and Medical and Regulatory Affairs department: Executive Medical Leaders, Clinical Research, Data Management, Biostatistics, Drug Safety and Pharmacoepidemiology, Regulatory, Preclinical Research
Also: External Medical Writing Vendors (individual consultant writers and CROs)
Contact Please apply by email Laura Walton at
[email protected]. If you know of someone who would be a good fit, feel free to forward them this information.