Regulatory Jobs
Hero Gradient Background
Aerial view of the BeOne Medicines campus in Hopewell, New Jersey, surrounded by green fields
BeOne Medicines logo

New · posted Nov 1

BeOne Medicines · Biotechnology

Senior Medical Writer

  • Remote, US
  • Remote
  • Full-time
  • Senior & Principal
Save
EmploymentFull-time
LocationRemote, US
DeadlineOpen until filled

The role

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

The Senior Medical Writer is responsible for writing, editing, and formatting clinical regulatory documents that conform to domestic and/or international regulatory submission and internal document standards, while meeting project timelines.  Clinical regulatory documents include, but are not limited to study reports, clinical study protocols or amendments, investigator brochures, and clinical sections of INDs, NDAs, MAAs and other regulatory submission documents.

Essential Functions of the job:

•         Works effectively with cross-functional groups to produce high-quality, scientifically accurate documents under strict timelines, and ensures consistency between related documents

•         Responsible for ensuring that assigned documents undergo a quality check before approval, and that documents are routed correctly during review and approval cycles

•         Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables

•         Review and edit documents, including those authored by others both internally and externally

•         Collaborate within the medical writing group to develop and maintain medical writing processes, standards, and tools (eg, SOPs, Work Instructions, templates, style guide, etc.)

•         Ensure clinical documents adhere to BeOne standards and regulatory guidelines

•         Coordinate and manage contract medical writers as needed

What you need

Knowledge and Skills

•         Demonstrated ability to communicate and write English clearly, concisely, and effectively

•         Well-organized: ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines and shifting priorities/demands

•         Independently motivated with good problem-solving ability

•         Excellent interpersonal skills; a team player

•         Ability to coordinate and manage communications to enable timely reviews from other authors and reviewers and to function as a collaborative team member

•         Strong project management skills

•         Recent and significant experience in writing of regulatory documents such as clinical study reports, protocols, and protocol amendments

•         Keen understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guidelines

•         Experience in writing clinical sections of INDs, MAAs, and NDAs is a plus

•         The technical/scientific ability to critically analyze, synthesize, and present complex information in well-constructed documents

•         Working knowledge of drug/biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred

•         Ability to comply with company and/or industry style guides and templates

•         Excellent attention to detail related to consistency, grammar, syntax, and scientific accuracy

•         Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel and Powerpoint

Supervisory Responsibilities:

•         N/A

Computer Skills:

•         Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems; proficiency in Microsoft Outlook, Excel and PowerPoint

Education Required:

•         Senior Medical Writer -- at a minimum 4 years' relevant industry experience as a regulatory medical writer, plus a BA/BS degree; PhD/PharmD in life sciences preferre

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

  • Fosters Teamwork
  • Provides and Solicits Honest and Actionable Feedback
  • Self-Awareness
  • Acts Inclusively
  • Demonstrates Initiative
  • Entrepreneurial Mindset
  • Continuous Learning
  • Embraces Change
  • Results-Oriented
  • Analytical Thinking/Data Analysis
  • Financial Excellence
  • Communicates with Clarity

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

Pay and benefits

$101,700 – $136,700 a year

Employer provided
How this compares

Salary Range: $101,700.00 - $136,700.00 annually

  • Medical, Dental, Vision

  • 401(k)

  • FSA/HSA

  • Life Insurance

  • Paid Time Off

  • Employee Stock Purchase Plan

Equal opportunity, accessibility and legal noticesBeOne Medicines's statements, word for word

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].

Job intelligence

The context around this role

Live data · November 1, 2026

Salary intelligence

How the pay compares

This role's midpoint is 18% below the US median for Clinical Evaluation & Medical Writing roles at this level.

This roleEmployer provided

$101,700 to $136,700 a year

Senior & Principal roles in the US12 roles publishing pay

Middle half $131,125 to $178,500, median $146,000
Annual base pay
Annual base payLowMedianHigh
This role$101,700—$136,700
All US$131,125$146,000$178,500

This role: BeOne Medicines's own published range. Comparisons: the base pay employers published on open Clinical Evaluation & Medical Writing roles at the same level on Regulatory Jobs, November 1, 2026. Nothing is estimated.

Career trajectory

Where this role sits in Clinical Evaluation & Medical Writing

The general path across 39 open Clinical Evaluation & Medical Writing roles on Regulatory Jobs, with the titles they carry most. Not BeOne Medicines's own promotion track.

  1. One step back

    Associate & Specialist

    Often: Clinical Scientist Intern · Medical Writer

  2. This role

    Senior & Principal

    Often: Senior Medical Writer · Principal Medical Writer

    $146K median18 open
  3. Next step

    Manager

    Often: Manager, Medical Writing, Immunology · Medical Writing Manager

    $150K median5 open
  4. Later

    Director

    Often: Associate Director, Medical Writing · Director, Medical Writing

    $210K median13 open

Skills DNA

What this role leans on

How many of the posting's 44 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.

Lab testing and methods: 1 lineDocumentation and SOPs: 12 linesInvestigations and CAPA: 1 lineRegulatory submissions: 2 linesData and digital systems: 3 linesClinical trial conduct: 3 linesCollaboration and leadership: 12 linesLab testingDocumentationInvestigationsSubmissionsData systemsClinical trialsTeamwork
  • Documentation and SOPs12
  • Collaboration and leadership12
  • Data and digital systems3
  • Clinical trial conduct3
  • Regulatory submissions2
  • Lab testing and methods1
  • Investigations and CAPA1

Company hiring pulse

BeOne Medicines on Regulatory Jobs

42
Open roles
41
Distinct roles
2
Locations

By discipline

  • Clinical21 50%
  • Regulatory11 26%
  • Quality9 21%

By level

  • Director18 43%
  • Manager11 26%
  • Senior & Principal9 21%
See all 42 BeOne Medicines roles

More roles at BeOne Medicines

All 42 BeOne Medicines roles

Similar Clinical Evaluation & Medical Writing roles elsewhere

Senior Medical Writer at BeOne Medicines

Open until filled. $102K–$137K a year, employer provided.

Job alerts