Medical Writing Manager Job at Randstad (東京23区)

Regulatory Writing Senior Manager

In this key role you will serve as the functional area lead on product teams, le...

Location

United States

Salary:

152684.00 - 193308.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience
Master’s degree and 6 years of directly related experience
Bachelor’s degree and 8 years of directly related experience
Associate’s degree and 10 years of directly related experience
High school diploma / GED and 12 years of directly related experience
Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
5+ years of experience in medical writing in the Biotech/Pharmaceutical industry

Job Responsibility

Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
Conduct the formal review and approval of authored documents, following applicable standard operating procedures
With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
Provide functional area input for Global Regulatory Plan and team goals
Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
Lead departmental and cross-departmental initiatives, as appropriate
Generate document timelines

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Associate Director / Director, Medical Writing

Beam is seeking a highly talented and motivated AD/Director to join our growing ...

Location

United States , Cambridge

Salary:

180000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree required
MS, PharmD, or PhD preferred in a life science or health discipline
12+ years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industry
A solid understanding of ICH guidelines, GxP, and relevant regulatory requirements
Demonstrated understanding of clinical regulatory documents (ie, protocol, IB, CSR, summaries for product filing, etc.) and experience as a lead author with such documents
Excellent communication skills, both oral and written
Ability to build strong relationships and work collaboratively across functions
Effective organizational and meeting skills and attention to detail
Experience with workflow management within standard document management systems
Ability to come onsite when needed such as for important meetings and team/company functions

Job Responsibility

Act as lead writer for clinical regulatory documents for the hematology program
Plan and lead the development of clinical study documents, working with cross-functional colleagues
Work closely with the regulatory team and other writers on regulatory document submissions
Assist with developing and maintaining medical writing process documents
Assist with evaluation and interpretation of the medical literature across several domains, such as study design, clinical development planning, statistical meaningfulness, and scientific rigor
Contribute to statistical output plans concerning organization and table layout for specific documents
Project management, strategic design, planning, team input, and reviews
Opportunities for management/mentorship of other writers

Fulltime

Senior Content Manager

Lead the development, review, and delivery of high-impact medical education cont...

Location

Canada , Toronto

Salary:

Not provided

Fullscript

Expiration Date

Until further notice

Requirements

8+ years in medical writing and editing, preferably with a focus on practitioner education
Deep understanding of scientific writing standards, editorial best practices, and regulatory requirements
Proven ability to write across modalities and tones—from protocols to presentations to podcast scripts
Confidence collaborating with freelancers and SMEs, setting expectations, and providing editorial direction
Familiarity with using AI tools to support content development, with strong human oversight

Job Responsibility

Create and oversee the development of evidence-informed educational content for healthcare professionals
Direct freelance medical writers, providing clear outlines, editorial guidance, and constructive feedback
Collaborate cross-functionally with internal teams and stakeholders to shape content formats and delivery strategies
Tailor content for diverse audiences and formats
Ensure quality and compliance by conducting or reviewing literature searches, validating accuracy of claims, reviewing for FTC/FDA compliance, and adhering to internal style and compliance guidelines
Conduct clear content intake processes to define context, audience, CME requirements, and format
Identify opportunities to improve workflows for editing, reviewing, and approving medical content
Ensure content quality and utility by measuring performance, applying insights, and adapting content to better meet user needs and maximize impact

Fulltime

Medical Writer

The healthcare industry requires that we abide by regulations from all around th...

Location

Malta , Marsa

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

BS or MS in scientific or clinical discipline with excellent writing skills
2 years of on-the-job experience in scientific/medical writing (e.g., clinical trial and regulatory documents) preferred but not mandatory
Knowledge of computer software Microsoft Word and Adobe Acrobat products
Microsoft Project and Visio are a plus
Experience in scientific and/or medical writing
Experience in the analytical evaluation of scientific data and written or oral presentation in a logical, clear, concise manner
Strong organizational skills and meticulous attention to detail
Familiarity with clinical trial-related and regulatory clinical submission templates and documents
Apply global regulatory authority regulations and/or guidance
Manage multiple projects with competing priorities

Job Responsibility

Develops high quality clinical documents ensuring scientific excellence and regulatory compliance
Writing, interpreting and summarizing clinical and non-clinical data
Compiling information and ensuring delivery within timelines
Ensure compliance of clinical documents with Baxter procedures, national and international regulatory requirements and guidelines
Collaborate with cross-functional team members and serve as MW representative at study team meetings
Prepare document timelines, with guidance from manager
Develop knowledge of one or more Baxter therapeutic areas

Medical Writer

The Medical Writer position with PrimeVigilance offers an opportunity to further...

Location

United Kingdom , Guildford

Salary:

Not provided

PrimeVigilance

Expiration Date

Until further notice

Requirements

PhD or MSc in Life Sciences or Healthcare (pharmacy, biology, chemistry, veterinary medicine)
Previous experience of drug safety medical writing, including PBRERs, DSURs, RMPs
Time management, organisation and multitasking skills with good attention to detail
Strong communication and presentation skills
Advanced knowledge of MS Office
Fluency in English

Job Responsibility

Author Medical Writing tasks including aggregate reports, RMPs and other documents needed throughout the product’s life cycle
Responsible for the quality and content of the document, and quality control review of documents prepared by Medical Writing peers
Continuous self-education in all aspects associated with Medical Writing activities
Active participation in trainings, maintenance, and development of quality system documents
Support in all PV operations associated with Medical Writing

Medical Writer

We are looking for individuals to write and edit clinical documents to support r...

Location

Malta , Marsa

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

BS or MS in scientific or clinical discipline with excellent writing skills
2 years of on-the-job experience in scientific/medical writing preferred but not mandatory
knowledge of computer software Microsoft Word and Adobe Acrobat products
Microsoft Project and Visio are a plus
experience in scientific and/or medical writing
experience in the analytical evaluation of scientific data and written or oral presentation in a logical, clear, concise manner
strong organizational skills and meticulous attention to detail
familiarity with clinical trial-related and regulatory clinical submission templates and documents
apply global regulatory authority regulations and/or guidance
manage multiple projects with competing priorities

Job Responsibility

Develop high quality clinical documents ensuring scientific excellence and regulatory compliance
write, interpret and summarize clinical and non-clinical data
compile information and ensure delivery within timelines
ensure compliance of clinical documents with Baxter procedures, national and international regulatory requirements and guidelines
collaborate with cross functional team members and serve as MW representative at study team meetings
prepare document timelines, with guidance from manager, as needed
develop knowledge of one or more Baxter therapeutic areas.

Scientific Specialist

ABOUT THIS ROLE: Key Accountabilities: Specialized Knowledge, Project Execution ...

Location

India , Remote; Hyderabad; Bengaluru

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

5-8 years prior experience preferred in a similar role, preferably within a medical communications agency environment
Degree and a higher degree in Life Sciences, Pharmacy, or Medicine (BSc, BA, PharmD, PhD, MD)
Intermediate computer and Internet skills, including knowledge of MS applications such as Excel, Word and PowerPoint
Strong oral and written communication skills
Strong problem-solving skills
Ability to acquire and apply specialized therapy area knowledge
Ability to interpret and organize scientific data
Ability to understand and implement marketing messages
Scientific writing competency
Proofreading and copyediting skills

Job Responsibility

Demonstrate sufficient understanding of department’s service offerings
Be familiar with and comply with all departmental procedures related to project delivery and tracking
Develop and maintain in-depth knowledge of client products and therapy areas on assigned accounts
Develop and maintain in-depth knowledge of relevant industry guidelines
Identify technical or process issues that are relevant to project delivery
Creatively and proactively apply specialist knowledge when working as part of a proposal and pitch development team
Undertake writing and editing to develop high-quality scientific content
Prioritize own work and manage project schedule to meet delivery deadlines
Be familiar with and work within project scope
Interpret scientific data accurately and appropriately

Quality Assurance Specialist, Medical Communications

Location

India

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experienced Medical Writer (1-2 years)
Scientific background and degree (PharmD, MD, PhD or Masters)
Knowledge of IT and digital solutions
Strong attention to detail and accuracy
Ability to manage and prioritize multiple, detailed activities
Results-orientated with fast and focused execution
Good communication, coordination and time management skills
Ability to work within a team or across multiple teams (including remotely) as well as independently
Fluent in oral and written English with high level of communication skills
Values teamwork, collaboration, and innovation

Job Responsibility

Cross check scientific information against cited references and ensure medical accuracy (fact check)
Ensure consistency with product label where applicable
Verify presence of essential information
Correct interpretation of scientific data from reference/sources
Alignment/formatting of content as per style guides/journal guidelines/congress guidelines
Ensure consistency of scientific content across different sections (including text, figures, tables)
Accurate bibliography/in-text citation and alignment of figures/graphs as per branding guidelines
Confirm that every sentence is source annotated, and each source annotation matches with respective reference and vice versa
Ensure that information is presented in a neutral manner without any interpretations and/or author’s conclusion
Track work and communicate with client team on job reviews, prioritization etc., through emails and teleconferencing if needed

Medical Writing Manager

Randstad

Location:
Japan , 東京23区

Category:
-

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Additional Information:

Job Posted:
April 29, 2026

Expiration:
June 29, 2026

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Job Posted:April 29, 2026

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