Senior Medical Writer

SciPro; New Jersey; Hybrid; USD 125,000 - 136,000; Full time

Job summary

SciPro is seeking a Senior Medical Writer for a late-stage biotech company in New Jersey. This hybrid role involves leading document development for oncology clinical studies and requires a PhD or Master's with relevant experience. The ideal candidate will have strong communication skills and a background in regulatory writing.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• Minimum qualifications: PhD or Master's with 3+ years of experience.
• Strong preference for PhD candidates with industry experience.
• Experience in oncology and authoring clinical study protocols.

Responsibilities

• Independently lead document development for clinical portfolio.
• Draft scientific and regulatory materials, ensuring compliance.
• Manage end-to-end document workflows and quality control.

Skills

Oncology experience

Strong communication skills

Document development

Education

PhD or Master's degree

Tools

Veeva

Job description

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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-mail] // 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

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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