Medical Writer

Hlx Life Sciences; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

Hlx Life Sciences is seeking a Senior/Medical Writer with oncology clinical trials experience to join our expanding medical writing team. You will develop, review, and edit clinical and regulatory documents to support Phase I–III oncology programs and regulatory submissions.

The role requires strong scientific communication, the ability to translate complex data into clear content, mentorship of junior writers, and rigorous adherence to ICH guidelines and company SOPs, with remote work aligned

Qualifications

• Bachelor's degree in a scientific or healthcare field is required.
• 3–5 years of medical writing or regulatory writing experience, oncology preferred.
• Experience with CROs/biotech/pharma and regulatory submissions is preferred.
• Excellent written and verbal communication with attention to detail.

Responsibilities

• Prepare, develop, review, and edit oncology clinical and regulatory documents.
• Draft CSRs, protocols, amendments, and regulatory submissions.
• Collaborate with cross-functional teams to ensure accuracy and consistency.
• Ensure documents comply with ICH-GCP, FDA/EMA guidelines, and SOPs.
• Mentor junior writers and contractors as needed.
• Stay updated on oncology developments and regulatory changes.

Skills

Written and verbal communication

Attention to detail

Project management

Mentorship

Education

Bachelor's degree in a scientific or healthcare field

Advanced degree preferred

Tools

MS Office Suite

Document management systems

Regulatory writing templates

Job description

Senior/Medical Writer – Oncology Clinical Trials

Location: Remote Candidates should be able to work within Eastern Time Zone business hours.

Position Summary

Our client is looking for a skilled Medical Writer with experience in oncology clinical trials to become part of our expanding team. The successful candidate will possess a strong understanding of oncology therapeutic areas and demonstrated experience developing high-quality scientific and regulatory documentation to support clinical development programs.

Key Responsibilities

• Prepare, develop, review, and edit clinical and regulatory documentation supporting oncology clinical trials, including:
• Clinical study protocols and protocol amendments
• Clinical study reports (CSRs)
• Regulatory briefing documents
• Clinical sections of INDs, NDAs, BLAs, and other regulatory submissions
• Work closely with cross-functional stakeholders, including Clinical Development, Regulatory Affairs, Biostatistics, Data Management, and Safety teams, to maintain document accuracy, quality, and consistency.
• Review, interpret, and translate complex clinical and scientific data into clear, concise, and scientifically accurate content.
• Ensure documentation adheres to applicable ICH guidelines, regulatory standards, and company SOPs.
• Support document planning activities, including timelines and deliverable coordination.
• Provide guidance and mentorship to junior medical writers and external contractors when required.
• Maintain awareness of developments within relevant therapeutic areas, evolving industry practices, and changes in regulatory guidance.

Qualifications

• Bachelor's degree in a scientific, healthcare, or related discipline required; an advanced degree is preferred.
• Minimum of 3-5 years of experience in medical writing, scientific writing, clinical research, regulatory affairs, or scientific communications.
• Previous experience within a CRO, biotechnology, pharmaceutical, or related life sciences organization is preferred; comparable experience will also be considered.
• Proven ability to interpret, evaluate, and effectively communicate complex scientific and clinical information.
• Strong knowledge of oncology indications, disease areas, and associated clinical endpoints.
• Hands-on experience writing documentation for Phase I–III oncology clinical trials and regulatory submissions.
• Solid understanding of ICH-GCP, FDA/EMA regulatory guidelines, and clinical trial processes.
• Excellent written and verbal communication abilities.
• Strong attention to detail, analytical thinking, and the ability to handle multiple assignments while meeting tight deadlines.
• Proficiency in MS Office Suite and document management systems, including familiarity with document templates and style guides.

Preferred Qualifications

• Previous experience working in a Contract Research Organization (CRO), biotechnology, or pharmaceutical setting.
• Knowledge of regulatory submission procedures, including eCTD and regulatory publishing.
• Active membership in relevant professional associations, such as AMWA or EMWA, is an advantage.