Senior Medical reputed company - FSP
reputed company is looking for a Senior Medical reputed company located reputed company in the United States or Canada. Early Development/Translational Medical Writing experience required. Job Purpose: The Senior Medical reputed company is responsible for the development of medical writing deliverables that support the clinical regulatory writing portfolio and works with guidance and reputed company to reputed company 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, reputed company meeting, quality
control, and document finalization under aggressive timelines
- Ensures communication between members remains reputed company 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 reputed company the needed tasks and subtasks, timelines, and assigned roles and responsibilities that reputed company the team to work reputed company and effectively to deliver reputed company milestone tasks and documents reputed company 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,
reputed company 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 reputed company 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 reputed company processes,
ICH-GCPs and other applicable requirements Skills:
- Focused writing and editing following defined processes and templates
- Expert level authoring in reputed company, understanding of reputed company 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 reputed company 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 reputed company and use story boards to drive statistical output planning, link data results to key
messages, and reputed company 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 reputed company, 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) #LI-KW1 #LI-REMOTE Apply tot his job Apply To this Job