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Senior Medical Writer-FSP - North Carolina, United States - Parexel
Description
When our values align, there's no limit to what we can achieve.
Parexel FSP is looking for a Senior Medical Writer- This position is remote and can be located anywhere in the United States or Canada
Job Purpose:
The Senior Medical Writer is responsible for the development of medical writing deliverables that support the clinical regulatory writing portfolio and works with guidance and oversight to achieve goals.
Key Accountabilities:
Leadership
• Leads cross-functional teams to draft agreed-upon scientific/medical content
that addresses data interpretation, product claims, and internal/external questions
• Coordinates and delivers document kick-off meetings with contributors or
representatives from cross-functional groups
• Coordinates activities for document review, consensus meeting, quality
control, and document finalization under aggressive timelines
• Ensures communication between members remains open and information is
disseminated appropriately
• Possible participation in the orientation and coaching of junior team
members
Regulatory Document Authoring
• Develops, coordinates, and oversees work plans for both individual and
multiple-document delivery, with all the needed tasks and subtasks, timelines, and assigned roles and responsibilities that enable the team to work efficiently and effectively to deliver all milestone tasks and documents within specified timelines
• Develops and maintains timelines in project plans, using project tracking
application following standard templates
• With minimal guidance from senior members of writing staff, prepares clinical
study reports (CSRs), protocols, investigator brochures (IBs), submission
data summaries, and other regulatory documents on investigational drugs in various stages of clinical development
• Manages messaging for consistency with historical information and in
alignment with agreed-upon strategy
• Applies lean authoring principles as part of document development and,
when applicable, structured content management (SCM) text libraries as part
of authoring process
• Ensures adherence to standard content, lean authoring, and messaging
across team members
• Works as an active member of cross-functional teams representing Medical
Writing
• Conducts appropriate literature searches, as needed
Compliance with Parexel Standards
• Complies with required training curriculum
• Completes timesheets accurately as required
• Submits expense reports as required
• Updates CV as required
• Maintains a working knowledge of and complies with Parexel processes,
ICH-GCPs and other applicable requirements
Skills:
• Focused writing and editing following defined processes and templates
• Expert level authoring in MS Word, understanding of MS Word functionality, and works with Word
add-ins that facilitate the management of fonts, styles, references, etc
• Follows directions, templates, and structured processes for delivering documents for review and finalization
• Participates in Medical Writing department initiatives, as appropriate.
• Researches regulatory requirements to remain current in the regulatory landscape
• Shares lessons learned and best practices
• Ability to work independently
• Ability to move across therapeutic areas to support business continuity and resource needs
• Ability to manage the tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completion
• Customer focused with communication skills commensurate with a professional working environment as well as effective time management, organizational, and interpersonal skills
• Fluent in reading and writing American English
Knowledge and Experience:
• Minimum 5 years in writing regulatory documents supporting global filings
• Oncology and/or Infectious Disease/Vaccines experience
• Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the EU and US
• Regulatory filing experience with a focus in authoring a broad set of different clinical document types that support regulatory filings such as protocols, amendments, CSRs, and common technical document summary documents with a preference for experience with Module 2.7, 5.2, CSRs, protocols, amendments, and IBs
• Understanding of clinical development process from program planning to submission, including clinical trial design as well as medical practices regarding procedures, medications, and treatment for different disease states
• Ability to facilitate review meetings, address feedback, and negotiate solutions/agreements
• Ability to interpret data and apply scientific knowledge to support regulatory document writing (i.e., IBs, protocols, amendments, CSRs, clinical summaries) as well as build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science
• Ability to develop and use story boards to drive statistical output planning, link data results to key messages, and develop templates as starting points for authoring
• Experience working on cross-functional teams with the ability to drive document content to support lean authoring
• Experience working in collaborative authoring tools and review tools, project tracking applications and document management systems; managing workflows eApproval/esignatures; and familiar with SCM and ability to author in an SCM environment using text libraries
• Flexibility in adapting to new tools and technology with capability of providing insight, alternatives, and suggestions based on previous experiences
• Capable of training writers/authors on the use of templates, guidelines, and tools
Education:
Bachelor's degree or equivalent (Life Science preferred)
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
