Senior Medical Writer - FSP

Parexel • Lansing, MI • 7h 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

Community Health Representative III - Birch CHC

Ingham County Human Resources • Lansing, MI • 8h ago

Hospital & Medical

Description (Employees in this position will perform the following general tasks and duties in working in various clinics. Not all clinics will perform the same duties or tasks, and employees will have specific tasks ass...

8h ago

Go to Apply

Ast/Asc/Full Prof. TS - Cancer Stem Cell Biology

Michigan State University(MSU) • East Lansing, MI • 16h ago

Hospital & Medical

Working/Functional Title Ast/Asc/Full Prof. TS - Cancer Stem Cell Biology Position Summary The Precision Health Program (PHP) at Michigan State University is accepting applications for a Tenure System faculty position, r...

16h ago

Go to Apply

Environmental, Health Safety EHS Support

Per Mar Security Services • Lansing, MI • 21h ago

Hospital & Medical

Overview Work with the best! Per Mar Security, an industry leader in providing integrated security solutions, is seeking hardworking motivated people. Established in 1953, Per Mar Security Services is the largest, family...

21h ago

Go to Apply

Dentist

Ingham County Human Resources • Lansing, MI • 1d ago

Hospital & Medical

Under the general direction of the Dental Director in collaboration with the Health Center Administrator, he/she diagnoses dental disease or injury, establishes treatment, planning, performs fillings, extractions and rel...

1d ago

Go to Apply

Certified Nursing Assistant (CNA)

Ciena Healthcare Management • Ovid, MI • 1d ago

Hospital & Medical

We are currently hiring for Full-Time Night Shift (6p-6a) Want to make a difference in someone's life? If you have patience, empathy and a true desire to care for those in need, you will love working as a Certified Nursi...

1d ago

Go to Apply

Supervisor, Medical Only

AF Group • Lansing, MI • 1d ago

Hospital & Medical

SUMMARY:nnEffectively supervises the day-to-day work and team performance of the Non-Exempt Medical Only Claim Specialists to ensure the goals and customer service expectations are met. Acts as a direct supervisor for no...

1d ago

Go to Apply

Safety and Health Auditor (United States)

3M • Lansing, MI • 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

ICU Veterinary Nurse I

Michigan State University(MSU) • East Lansing, MI • 2d ago

Hospital & Medical

Working/Functional Title ICU Veterinary Nurse I Position Summary Provides patient care for ill and injured animals in the Veterinary Medical Center. This position will be primarily providing support to our Small Animal E...

2d ago

Go to Apply

Finance & Program Management Associate, Digital Health

Baylor Scott & White Health • Lansing, MI • 2d ago

Hospital & Medical

Job Summary The Finance & Program Management Associate serves as a key team player providing financial analysis and strategic planning support to the four pillars of the Digital Health space. Responsibilities Serves...

2d ago

Go to Apply

Financial Specialist-2, Environmental Health Bureau

State of Michigan • Lansing, MI • 2d ago

Hospital & Medical

Financial Specialist-2, Environmental Health Bureau Print ( https://www.governmentjobs.com/careers/michigan/jobs/newprint/5259550 ) Apply ? Financial Specialist-2, Environmental Health Bureau Salary $31.99 - $47.75 Hourl...

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.