Senior Regulatory Medical Writer, Client-embedded, FSP

This role will provide business-aligned guidance focused on governance, compliance, and operational risk management. You will partner with leaders, compliance stakeholders, and cross-functional teams to translate complex issues into practical recommendations. The position offers the opportunity to strengthen responsible execution, improve decision-making, and support sustainable growth within a life sciences environment.

Location: Remote - US based candidates only, no visa sponsorship available

Responsibilities

• Write and summarize routine clinical documents like study reports and protocols
• Author complex clinical and scientific documents such as INDs and MAAs
• Collaborate with cross-functional teams to ensure accuracy of documents
• Align documents with regulatory guidelines and industry best practices
• Provide input on content, structure, and presentation of documents
• Review documents from team members and provide constructive feedback
• Manage timelines and deliverables for assigned projects
• Mentor junior medical writers to ensure high-quality work

Requirements

• Bachelor's degree in a scientific discipline; advanced degree preferred
• 5+ years of relevant experience in regulatory or medical writing
• Experience in the pharmaceutical/CRO industry preferred
• Additional qualifications in medical writing, such as AMWA or EMWA, are advantageous
• Equivalency of education, training, and/or experience may be considered

Pay

$105,000 – $125,000 annually

Benefits

• Choice of medical, dental, and vision plans, including health incentive programs
• Access to employee assistance and family support programs, plus commuter benefits and tuition reimbursement
• At least 120 hours of paid time off (PTO) and 10 paid holidays annually
• Paid parental leave options, including bonding and caregiver leave
• Retirement savings programs, including a competitive 401(k) plan
• Employee Stock Purchase Plan (ESPP) offering stock at a discount