Medical Writer

Advanced Recruiting Partners; United States; On-site; USD 56,000 - 125,000; Full time

Job summary

A leading recruitment firm is seeking a Medical Writer responsible for drafting and editing clinical study documentation to meet regulatory standards. Candidates should have a degree in Life Sciences and a strong background in medical writing, preferably in a CRO or pharmaceutical setting. Exceptional attention to detail and communication skills are essential to handle complex medical information efficiently. This full-time role offers an opportunity to contribute to critical clinical research initiatives.

Qualifications

• 2+ years of experience in medical writing, preferably in a CRO or pharmaceutical environment.
• Proven experience writing clinical study synopses and protocols.
• Solid understanding of clinical trial design and regulatory requirements.

Responsibilities

• Draft, revise, and finalize clinical study synopses and protocols.
• Collaborate with cross-functional teams to ensure document accuracy.
• Manage timelines and prioritize multiple writing assignments efficiently.

Skills

Attention to detail

Excellent written communication

Organizational skills

Ability to work independently

Ability to communicate complex information

Education

Bachelor’s degree in Life Sciences

Master’s or Ph.D. (preferred)

Job description

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The Medical Writer will be responsible for authoring and editing clinical study synopses and full protocols in compliance with regulatory requirements, internal standards, and client expectations. This role requires strong scientific and regulatory knowledge, attention to detail, and the ability to communicate complex medical information clearly and concisely.

Key Responsibilities:

• Draft, revise, and finalize clinical study synopses and protocols
• Interpret clinical and scientific data to create high-quality, scientifically accurate documents
• Collaborate with cross-functional teams including clinical operations, regulatory, and biostatistics to ensure document accuracy and consistency
• Ensure all documents adhere to applicable regulatory guidelines (ICH-GCP, FDA, EMA) and sponsor-specific templates or requirements
• Participate in internal and client meetings to gather relevant input and incorporate feedback into document revisions
• Manage timelines and prioritize multiple writing assignments efficiently

Required Qualifications:

• Bachelor’s degree in Life Sciences or related field (Master’s or Ph.D. preferred)
• 2+ years of experience in medical writing, preferably within a CRO or pharmaceutical/biotech environment
• Proven experience writing clinical study synopses and protocols
• Solid understanding of clinical trial design, ICH-GCP guidelines, and regulatory requirements
• Excellent written and verbal communication skills
• Strong organizational skills and attention to detail
• Ability to work independently and collaboratively in a fast-paced environment

Preferred Qualifications:

• Experience working with early-phase clinical trials
• Familiarity with document management systems and version control tools
• Prior experience interacting with clients or external stakeholders

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  Staffing and Recruiting

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