Senior Medical Writer - FSP

Parexel•Southport, NC

About The Position

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Parexel is looking for a Senior Medical Writer located anywhere in the United States or Canada. Early Development/Translational Medical Writing experience required. 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.

Requirements

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
Bachelor’s degree or equivalent (Life Science preferred)

Responsibilities

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
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
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
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