Senior Medical Writer

Green Life Science; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

A leading biotech company is seeking an experienced Medical Writer to support regulatory submissions and clinical development in oncology. The role requires strong knowledge of US and international regulatory requirements and experience in authoring clinical documents. Candidates should have 5–10 years in medical writing within the pharma or biotech industries, along with expertise in oncology clinical development. This position involves collaboration with cross-functional teams globally and ensuring compliance with regulatory guidelines. Competitive compensation is offered.

Qualifications

• 5–10+ years of medical writing experience in the pharma/biotech industry.
• Strong experience in oncology clinical development.
• Experience authoring INDs/CTAs and major regulatory submissions.

Responsibilities

• Lead authoring and review of regulatory documents.
• Coordinate preparation of Clinical Trial Applications (CTAs).
• Ensure compliance with EMA, FDA, ICH, and GCP guidelines.
• Oversee medical writing activities performed by CROs.

Skills

Oncology clinical development

Regulatory document authoring

Cross-functional collaboration

Knowledge of ICH and GCP guidelines

Clinical research methodology

Education

Bachelor’s degree

PhD, PharmD, or advanced life sciences degree

Tools

MS Word

Excel

PowerPoint

Job description

We are seeking an experienced Medical Writer with a strong background in oncology drug development to support global regulatory submissions and clinical development programs. This role will be responsible for authoring and coordinating high-quality regulatory and clinical documents in collaboration with cross-functional teams across Europe and globally.

The ideal candidate will have extensive experience in oncology clinical development, strong knowledge of US and international regulatory requirements, and the ability to operate effectively in a fast-paced biotech or pharmaceutical environment.

Key Responsibilities

• Lead authoring and review of regulatory documents including:
• Clinical Study Protocols and Amendments
• Clinical Study Reports (CSRs)
• IND/CTA submissions (US and global)
• NDA/BLA/MAA clinical modules
• Annual reports and regulatory responses
• Coordinate preparation of Clinical Trial Applications (CTAs) for European submissions and support global filings.
• Ensure consistency and alignment of messaging across regulatory documents within clinical programs.
• Collaborate closely with Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, and CMC teams.
• Interpret and apply EMA, FDA, ICH, and GCP guidelines to ensure compliance.
• Support publication activities including manuscripts, abstracts, and congress presentations.
• Oversee and manage medical writing activities performed by CROs/vendors where applicable.
• Contribute to development and improvement of SOPs, templates, and document standards.
• Ensure all deliverables meet agreed timelines and quality standards.

Qualifications & Experience

• Bachelor’s degree required; PhD, PharmD, or advanced life sciences degree preferred.
• 5–10+ years of medical writing experience within pharmaceutical or biotechnology industry.
• Strong experience in oncology clinical development (solid tumors or hematology preferred).
• Demonstrated experience authoring INDs/CTAs and major regulatory submission documents.

In-depth knowledge of:

• ICH guidelines
• GCP requirements
• EU Clinical Trial Regulation (CTR)
• Experience working with cross-functional global teams.
• Strong understanding of clinical research methodology and biostatistics.
• Experience managing CRO medical writers is an advantage.
• Proficiency in MS Word, Excel, PowerPoint, and document management systems.