Senior Medical Writer - FSP

Parexel • Columbia, SC • 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

PwC Technology - Product Manager

PwC • Columbia, SC • 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

MRI Tech

Health Advocates Network • Columbia, SC • 1d ago

Hospital & Medical

Benefits We Offer: Comprehensive health, prescription, dental, vision, life, and disability plans Competitive pay rates Referral opportunities ? Refer a friend & Cash in! Travel reimbursement and per diem allowances...

1d ago

Go to Apply

Safety and Health Auditor (United States)

3M • Columbia, SC • 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

Licensed Practical Nurse

PruittHealth • Ridgeway, SC • 2d ago

Hospital & Medical

LICENSED PRACTICAL NURSE- PRN Join the PruittHealth family, where the health and safety of our workforce is our top priority! We're not only committed to your career, we're committed to the health and safety of all our n...

2d ago

Go to Apply

Licensed Practical Nurse

PruittHealth • Ridgeway, SC • 2d ago

Hospital & Medical

LICENSED PRACTICAL NURSE Join the PruittHealth family, where the health and safety of our workforce is our top priority! We're not only committed to your career, we're committed to the health and safety of all our nurses...

2d ago

Go to Apply

Medical Receptionist

CenterWell • Columbia, SC • 2d ago

Hospital & Medical

Become a part of our caring community and help us put health first You will work in an onsite outpatient clinic. You will report to the Center Administrator at our Fairwold Clinic in Columbia, SC. You will perform admini...

2d ago

Go to Apply

Medical Assistant

CenterWell • Columbia, SC • 2d ago

Hospital & Medical

Become a part of our caring community and help us put health first You will work in an onsite outpatient clinic. You will report to the Center Administrator in our Fairwold Clinic in Columbia, SC. You will perform clinic...

2d ago

Go to Apply

Registered Nurse

BAYADA Home Health Care • Gadsden, SC • 3d ago

Hospital & Medical

We'd be lucky??to have you. Join BAYADA as a nurse. $5,000 SIGN-ON RETENTION BONUS FOR FULL-TIME COMMITMENT AVAILABLE!! Our Columbia Skilled Office is interested in a Registered Nurse (RN) who has a passion for home care...

3d ago

Go to Apply

Nurse Practitioner - MC

US Tech Solutions • Lexington, SC • 3d ago

Hospital & Medical

$75-$76 per hour Lexington, SC Contract Duration: 3 months contract Note: Must have minimum 1 year of experience as a Family Nurse Practitioner in primary care Must Have active DEA Schedule: M-F 8:30-7:30, Sat 9-5:30, Su...

3d ago

Go to Apply

Nurse Practitioner - MC

US Tech Solutions • Irmo, SC • 3d ago

Hospital & Medical

$75-$77 per hour Irmo, SC Contract Duration: 3 months contract Duties Provide Primary and Family evidenced-based care inclusive of accurate assessment, diagnosis, treatment, management of health problems, health counseli...

3d 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.