Title: Medical Writer Principal
Location: United States:massachusetts
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world:class research, collaboration with the global patient community
, and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. Genzymes portfolio of transformative therapies, which are marketed in countries around the world, represent groundbreaking and life:saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the worlds largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more atgenzyme.
This position is responsible for providing high quality clinical documentation. The purpose of this job is to create and to manage creation by others of any type of clinical regulatory document (e.g., protocol, CSR, CIB, clinical sections of IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format. This position is for an independent, proactive, very experienced medical writer with demonstrated leadership in preparing multiple key summary submission documents (i.e., Clinical Summary of Safety, Clinical Summary of Efficacy, Clinical Overview) for the CTD and demonstrated experience managing the project work of other medical writers.
As an integral part of a clinical and/or study team, the position holder ensures the quality, compliance with internal and external standards, and timely and efficient production of English:language clinical documents using an electronic document management system. The position holder must contribute scientific knowledge, analytical skills, experience, independence, and insight to the analysis of data, the preparation of reports, and the production of registration dossiers.
MAJOR DUTIES and RESPONSIBILITIES:
: Work with and lead project teams to prepare clinical regulatory documents, including protocols, study reports, investigator brochures, INDs/IMPDs, and CTDs according to company and agency guidelines in order to support drug development under strict timelines.
: Manage the project work of other medical writers (internal and remote) to prepare clinical regulatory documents. This includes training and mentoring in addition to participation in assessing workload, managing work assignments, and fulfilling administrative responsibilities.
: Work effectively with company document management system and related tools, templates, and procedures in order to ensure efficient publishing of documents and dossiers.
: Ensure a consistent style of presentation of clinical document to maintain quali