Medical Writer

About This Role

This role is for a Medical Writer who will manage and oversee assigned medical writing projects within a clinical-stage biopharmaceutical company. The core of the job involves preparing high-quality clinical documentation for regulatory submissions, ensuring scientific content, organization, accuracy, and clarity. The position is based in the Princeton, NJ office.

Responsibilities

• Write, edit, and/or manage the production of high-quality clinical documentation, including clinical study protocols, synopses, and clinical study reports for submission to regulatory authorities in support of marketing applications and BLAs
• Act as a member of clinical trial teams
• Follow and track clinical documentation milestones
• Write/edit other strategic documents, as required

Requirements

• Master's degree in a life sciences discipline or at least 3 to 4 years of experience as a medical writer in the pharmaceutical industry
• PhD with at least 1 year experience as a medical writer in the pharmaceutical industry
• Excellent writing and effective communication skills
• Proven interpersonal, organizational and problem-solving skills in a matrix management environment
• Knowledge of FDA and ICH guidelines
• Skilled in clinical data interpretation
• Proven experience writing/supporting major documents (e.g., protocols, CSRs, ISE, ISS, and Clinical Overview etc.)

Nice to have:

• Knowledge of drug development and regulatory requirements to guide document organization
• Project management experience including the use of negotiation and influence to ensure document timelines are met while maintaining high quality

Benefits

• 100% paid employee premiums for medical/dental/vision
• Short-term disability (STD)
• Long-term disability (LTD)
• 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years
• 15 PTO days per year
• Sick leave
• 11 paid holidays

About the Company

SystImmune is a well-funded clinical-stage biopharmaceutical company specializing in developing innovative cancer treatments using established drug development platforms, including bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). It has multiple assets in various stages of clinical trials for solid tumor and hematologic indications, alongside a robust preclinical pipeline of potential cancer therapeutics in discover and IND-enabling stages. The company is located in Redmond, WA and Princeton, NJ.