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Sr. Medical Writer (REMS)
Specific Job Duties:
Preparation of departmental deliverables, such as clinical protocol development (required), observational/late stage reporting experience specifically in writing KABs/REMS reports, regulatory clinical study reports for all phases, IND, NDA and CTD summary documents, and manuscripts for publication
Represent Medical Writing on UBC and client project teams for project planning, timeline development, and resource management
Knowledge of the utilization and implementation of sponsor related style guides
Participate in proposal preparation and resource allocation
Proactively manage timelines for medical writing deliverables
Represent Medical Writing at bid defenses and internal meetings
Assist in the development of key messaging and operational procedures
Ability to review and understand client report templates and style guides.
Coordination/consultation with other UBC departments such as SERRM, Data Management, Programming, Biostatistics, Quality Assurance, and Project Management on Medical Writing projects
Develop/maintain medical writing SOPs
Perform quality control and peer reviews of documents and assess compliance with regulatory requirements, clients requests, and SOPs
Inform Medical Writing Department head of potential problems/challenges
Conduct comment resolution meetings
Requirements:
Bachelors degree in biological sciences or equivalent
At least 8+ years experience in medical writing within the pharmaceutical/CRO industry
Advanced word processing skills (Microsoft Word) including proficiency with tables
Strong organization and prioritization skills
Attention to detail/high degree of accuracy
Ability to clearly and effectively communicate and interact with clients
Strong analytical, problem-solving, and data interpretation skills
Good communication skills
Good interpersonal skills
Ability to work both independently and as a part of a project team
Exposure and familiarity with relevant ICH and FDA guidelines
Understanding of templates and styles
Please send CVs to vijaya@fusionlifesolutions.com