Senior Manager Medical Writing

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Job description

The Senior Manager of Medical Writing will be involved in all elements of clinical writing for assigned programs in order to guarantee that needed documentation is completed on time and to the highest possible standards (scientific, ethical, regulatory, and good clinical practice). Among the activities are:

• Assisting with the development of document review procedures and standards, as well as the construction of document writing tools.


• Introducing and implementing department-wide initiatives for resourcing, medical writing procedures, and document standards


• Assisting with the creation and management of standard operating procedures (SOPs) and writing tools such as templates and style guidelines


• Providing medical writing templates, tools, SOPs, and standards training to other functional areas


• Conducting literature searches for products under development and adding to the publication database


• Identifying, managing and budgeting outside resources (writers, editors)


• Authoring clinical research protocols and protocol changes, clinical study reports, investigator brochures, clinical sections of lNDs/NDA/BLAJMAAs, and other documents such as regulatory briefing package clinical parts


• Creating and managing document creation, revision, and completion timeframes


• Coordinating review cycles, addressing comments, and initiating discussions to ensure that papers are completed on schedule


• Ensuring quality control assessment of documents is planned and scheduled to guarantee completeness and correctness of data presentation

Skills and experience required :

• An advanced degree (or equivalent relevant experience) in a life sciences or clinical discipline.


• Ability to effectively communicate complex ideas, both orally and written.


• Strong scientific/medical background.


• 5+ years of medical writing experience (3+ years regulatory document management)


• An ability to work independently across multiple projects, and to meet deadlines.


• A keen eye for detail (in relation to both scientific content and editorial standards).


• Enthusiasm for working with physicians who are experts in their field.

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

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