Senior Medical Writer - FSP / Sponsor Dedicated

Parexel FSP is looking for a Senior Medical Writer- This position is remote and can be located anywhere in the United States or Canada!

Extensive Phase 1 and PK (pharmacokinetic) experience required. Protocol and CSRs (full and synoptic) writing in a range of therapeutic areas also 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.

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)