SciPro is hiring: Senior Regulatory Medical Writer / Regulatory Medical Writer i
SciPro, Trenton, NJ, United States
Overview
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
Medical Writer
or
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!
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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
Medical Writer
or
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!
#J-18808-Ljbffr