MedFocus Sr. Med. Writer, Devices 1326 in Massachusetts
Job Description: Position Summary:
Executes medical writing activities for projects, including technical report writing and publications, for wearable devices and novel data streams group. Assumes primary responsibility for preparation of technical reports and publications working with the cross-functional team, under the direction of the manager. Participates on relevant project teams and task forces, and provides guidance to team members a wide range of issues related to document preparation and publication submissions (style and process), and project-specific guidance related to content and organization of specific documents.
Duties and Responsibilities:
Prepares technical reports and drafts manuscripts for publication in accordance with team input, with oversight from the manager.
As required, provides review and substantive editing of contributions from internal Company team members and external collaborators.
Provides guidance for document preparation to team members from other functional areas ( Clinical, Biostatiscs, etc., ).
Participates on functional teams that address requirements or issues related to document preparation.
EDUCATION, EXPERIENCE AND SKILLS: Required:
Bachelor’s degree in science, health profession, or journalism
Minimum 5 years’ experience of technical report writing for pharma or biotechnology; experience with writing regulated documents, e.g. CSR, IB, noon-clinical study reports, is highly desirable. Proven record of preparing publications for biomedical peer-reviewed journal is required. Knowledge and Skills:
Basic understanding of scientific methodology, with ability to understand clinical development, including the phases, processes, and techniques used within a clinical development environment
Ability to understand requirements related to the preparation and production of technical reports and scientific publications.
Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within cross-functional teams and with external collaborators.
Ability to identify issues and generate solutions or request appropriate intervention by management.
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