Get new jobs for this search by email

Get AI-powered advice on this job and more exclusive features.

This range is provided by SciPro. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$125,000.00/yr - $136,000.00/yr

Additional compensation types

Annual Bonus

Direct message the job poster from SciPro

Principal Headhunter, Clinical Development

SciPro is partnered with an exciting late-stage biotech that is seeking a Senior Medical Writer to join their team full-time. This role will be responsible for independently leading document development by authoring and editing medical and regulatory writing deliverables that support their clinical portfolio.

The Senior Medical Writer will report to the Senior Director, Medical Writing and be responsible for the oversight of oncology clinical study protocols and reports, investigational new drug applications (INDs), future new drug applications (NDAs), investigator brochures, and reviewing informed consent forms and regulatory briefing materials.

This is a hybrid position with 3 days onsite - the biotech has offices near San Bruno and Jersey City.

Additional Responsibilities include but are not limited to:

• Independently draft a wide range of scientific and regulatory materials, such as study plans, technical summaries, clinical evaluations, scientific communications, and submissions, ensuring alignment with organizational and industry standards.
• Produce content for diverse audiences, including regulatory bodies, investigators, and scientific communities, adhering to required formats, templates, and submission guidelines.
• Analyze and interpret complex data sets while applying regulatory, compliance, and scientific frameworks to support high-quality document development.
• Manage end-to-end document workflows independently, including planning, drafting, review coordination, and quality oversight.
• Contribute to the continuous improvement of writing practices, streamlining processes for greater efficiency and consistency.
• Perform quality control reviews to support clarity, consistency, and alignment with style guidelines and regulatory expectations.
• Lead collaborative efforts with multidisciplinary teams, facilitating meetings, resolving feedback, managing timelines, and mitigating potential project risks.
• Review and interpret scientific and clinical content, contributing to the accurate and effective presentation of data through narrative, tables, and visual formats.

Required Skills & Qualifications:

• Minimum qualifications: PhD , or a Master's degree with 3+ years of experience – strong preference for PhD candidates who have industry experience under their belt.
• Major focus on oncology experience and authoring clinical study protocols within the oncology space.
• Experience with Veeva for publishing activities.
• Ideal candidate will come from an industry or CRO background.
• Strong communication skills required – able to work cross functionally and interact independently with senior stakeholders.

Please apply or reach out to E.Steckler@sciproglobal.com // 424-610-5981 for further details!

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science and Writing/Editing

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

Referrals increase your chances of interviewing at SciPro by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Get notified when a new job is posted.

Sign in to set job alerts for “Medical Writer” roles.

Senior Medical Writer, Medical Communications

Technical Writer [Must Have ISO 13485] - REMOTE

Basking Ridge, NJ $65.00-$85.00 1 week ago

Woodcliff Lake, NJ $90,000.00-$110,000.00 2 days ago

Technical Writer & Doc Control Specialist

Senior Medical Writer Evidera - Medical Information

Morristown, NJ $49,305.00-$71,645.00 5 days ago

FSP Start-Up Associate - Hybrid - Lawrenceville, NJ

New Brunswick, NJ $73,161.00-$73,161.00 1 month ago

Staff Clinical Evaluation Specialist (Remote)

Clinical Services: Clinical Project Associate

Research Associate II (Research Coordinator)

Newark, NJ $64,244.00-$64,244.00 3 weeks ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.