Pharmacovigilance Medical Writing Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7gxmko

Pharmacovigilance Medical Writing Manager Position
Summary The Pharmacovigilance Medical Writing Manager is
responsible for writing and editing a variety of scientific and
medical content, including but not limited to the following:
Aggregate Reports, Risk Management Plan(RMP), Risk Evaluation and
Mitigation Strategies (REMS), protocols, investigator brochures,
clinical study reports, responses to regulatory questions and other
clinical and regulatory documents, in accordance with applicable
Good Clinical Practice requirements and legislation. The medical
writer will work independently to review Client documents and
author the reports. The medical writer will collaborate with the PV
Project Leads and other relevant functions to ensure accuracy and
clarity of all relevant content. Essential To accomplish this job
successfully, an individual must be able to perform, with or
without reasonable accommodation, each essential function
satisfactorily. Reasonable accommodations may be made to help
enable qualified individuals with disabilities to perform the
essential functions.



Essential Functions Statement(s) Proactively
contribute to development and implementation of Medical Writing
best practices, policies, SOPs and process improvement initiatives
leading to efficient and improved standards and systems for
authoring, review, editing and finalization of documents, in
compliance with applicable company SOPs and regulations; Develop
and refine templates to improve inter-department/program alignment
and efficiency in accordance with standards and regulatory
guidelines and requirements; Define document development strategy
and resource needs for programs, including medical writing vendor
engagement and oversight; Drive document execution tactics, such
as: define document development, implement review and revision
processes, develop timelines including timelines related to
document birth dates, assign resources, facilitate document-related
meetings, provide cross-functional u

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7gxmko