Associate Director, Medical Writing

Job Summary The Associate Director, 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 and to act as a Medical Writing coordinator for the preparation of drug safety-related documents. 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’s brochures for Phase I to IV clinical trials, and drug safety-related documents. 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. Non-project activities also include Data Disclosure, EudraCT, ClinicalTrials.gov.   Main Responsibilities, Activities, Duties, and Tasks Prepare/coordinate and deliver high quality clinical sections of submissions (IND/IMPD/NDA/MAA/sNDA) and responses to regulatory authorities in eCTD format as required. 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 prepare the documents in an efficient manner for submissions to regulatory authorities. Prepare/coordinate clinical documents as required, e.g., Clinical Study Reports (Phase I-IV) with associated appendices, Investigator’s Brochures, Clinical Expert Statements / Addendum to the Clinical Overview for product renewals, and drug safety-related documents such as Periodic Safety Update Reports (PSURs/PBRERs), Development Safety Update Reports (DSURs), and Risk Management Plans (RMPs). Resolve conflicting comments among reviewers and, if applicable, collate comments for submission to consultants/contract research organization (CRO) as necessary. Manage projects within pre-defined budget, pre-defined internal resources, and time constraints. Manage the activities of external resources and medical writing vendors (i.e., individual consultant medical writers and CRO medical writers). Provide status reports for ongoing projects. Act as a Medical Writing coordinator for the preparation of drug safety-related documents such as PSURs/PBRERs. Review medical documents generated outside of Medical Writing (e.g., study protocol, Statistical Analysis Plan, tables and listings). Prepare/review SOPs, Working Guides, and document templates.   Supervisory Responsibilities Not Applicable.   Education B.S. degree required, advanced degree/Life Sciences preferred.   Professional Experience, Knowledge & Technical Skills 7-10 years of experience in regulatory writing within the pharmaceutical industry, including managing global registration dossiers. Experience with diagnostic imaging agents preferred. Vendor/consultant management experience preferred. Experience with interactions with regulatory groups and formulating regulatory strategies desirable. Working knowledge of worldwide registration document requirements, including ICH guidelines, EMA requirements, and FDA guidelines and requirements. Demonstrated medical writing skills and a high-level interpersonal skill to interact effectively in team and matrix work settings. Sensitivity to cultural differences. Excellent written/oral communication skills and highly proficient word processing skills. Ability to think clearly, get appropriate input from different disciplines as needed, provide focused answers. Ability to multi-task, deal with competing priorities, meet aggressive timeline expectations. Team player who is cost-conscious, adaptable to change, accepts new challenges, excellent organization skills, quality focused, with proven analytical and problem-solving abilities. Competency in the use of Documentum (or a similar document management system) is desired.   Core Relationships Teams within the Global Groups and Medical and Regulatory Affairs department: Medical Planning and Management Physicians, Clinical Research, Data Management, Biostatistics, Drug Safety and Pharmacoepidemiology, Regulatory, Preclinical Research. External Medical Writing Vendors (individual consultant writers and CROs).   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 employee must be able to communicate via telephone, written correspondence, or spoken word in order to perform the essential duties of the position.