Senior Medical Writer - FSP

Parexel • Salt Lake City, UT • 9h ago

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.

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)

LI-KW1

LI-REMOTE

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.

Parexel

Go to Apply

Share this job

Similar Jobs

Dispensing Pharmacist - Long Term Care - Full Time

CVS Health • Millcreek, UT • 6h ago

Hospital & Medical Sponsored

We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate...

6h ago

Go to Apply

Pharmacist, Pharmacy, Full Time, Evening Shift

CVS Health • Millcreek, UT • 6h ago

Hospital & Medical Sponsored

6h ago

Go to Apply

Local Medical Equipment Delivery Driver

KOLOB HOME MEDICAL • West Valley City, UT • 9h ago

Hospital & Medical

About Rotech Join a Leader in Home Healthcare At Rotech Healthcare Inc., we're more than a medical equipment provider-we're a trusted partner in patient care. As a national leader inventilators, oxygen therapy, sleep apn...

9h ago

Go to Apply

PwC Technology - Product Manager

PwC • Salt Lake City, UT • 1d ago

Hospital & Medical

Specialty/Competency: IFS - Information Technology (IT) Industry/Sector: Not Applicable Time Type: Full time Travel Requirements: Up to 20% At PwC, our people in software and product innovation focus on developing cuttin...

1d ago

Go to Apply

Endoscopy Tech

HCA Healthcare • Draper, UT • 1d ago

Hospital & Medical

Are you passionate about the patient experience? At HCA Healthcare, we are committed to caring for patients with purpose and integrity. We care like family! Jump-start your career as an Endoscopy Tech today with Lone Pea...

1d ago

Go to Apply

Medical Assistant Instacare

Intermountain Health • Taylorsville, UT • 1d ago

Hospital & Medical

Job Description: A Medical assistant has accountability for providing care to patients in an ambulatory clinic setting. This will involve caring for patients with acute and chronic needs. A Medical Assistant will be resp...

1d ago

Go to Apply

Medical Policy Director

Cotiviti, Inc. • South Jordan, UT • 1d ago

Hospital & Medical

Medical Policy Director Job Locations US-Remote ID 2026-18561 Category Client Services Position Type Full-Time Overview The Medical Policy Director (MPD) is a key member of the Go To Market team. Along with the Client En...

1d ago

Go to Apply

Safety and Health Auditor (United States)

3M • Salt Lake City, UT • 1d ago

Hospital & Medical

Job Description: Safety and Health Auditor (United States) Collaborate with Innovative 3Mers Around the World Choosing where to start and grow your career has a major impact on your professional and personal life, so it'...

1d ago

Go to Apply

Senior Consultant - Indirect Tax - Data Technologist

Deloitte • Salt Lake City, UT • 2d ago

Hospital & Medical

Are you a strategic and creative Tax professional who likes solving complex indirect tax issues? Are you ready to make a greater impact on organizations by combining tax consulting solutions and innovative technology tha...

2d ago

Go to Apply

Neurologist

CommonSpirit Health • Salt Lake City, UT • 2d ago

Hospital & Medical

Job Summary and Responsibilities As a physician-facing organization, our Physician Group is passionate about high-value, top quality care made accessible in every community we serve. Our resources include supply chain ex...

2d ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.