SystImmune is a leading and well-funded clinical-stage biopharmaceutical company located in Bothell, WA and Princeton, NJ. It specializes in developing innovative cancer treatments using its established drug development platforms, focusing on bi-specific, multi-specific antibodies, and antibody-drug conjugates (ADCs). SystImmune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials. SystImmune has a robust preclinical pipeline of potential cancer therapeutics in the discover and IND-enabling stages, representing cutting-edge biologics development. We offer an opportunity for you to learn and grow while making significant contributions to the company's success.

The successful candidate is responsible for authoring, editing, coordinating, and maintaining complex clinical, scientific, or regulatory documents. The senior medical writer will partner cross-functionally with client teams in Clinical Development, Clinical Operations, Regulatory Affairs, Biostatistics, Clinical Safety, and Nonclinical Sciences in leading the planning and preparation of high-quality regulatory documents.

The Medical Writer serves as a document lead for clinical protocols, protocol amendments, investigator brochures, clinical study reports, briefing packages, IND modules, safety reporting documents, and regulatory responses while ensuring scientific accuracy, consistency, and compliance with applicable regulatory requirements and company standards under brisk timelines.

This is an onsite position that is located at our Princeton, NJ office.

Key Responsibilities

• Lead development and maintenance of early and late stage clinical protocols, amendments, and clinical study reports, ensuring accuracy, clarity, completeness, and compliance with established formatting, content and style guidelines
• Author and edit IND, CTA, and global regulatory submission documents.
• Prepare responses to health authority information requests.
• Interpret data and create shell documents to support authoring
• Plan and lead kickoff meetings
• Facilitate resolution of review feedback including planning and leading comment resolution meetings (curate review comments to ensure meetings are efficient)
• Follow-up with individual team members as needed to resolve outstanding review feedback
• Perform peer QC review as needed
• Conduct literature review and reference management to support clinical-development strategies.
• Contribute to medical writing operational initiatives (e.g., templates, style guides, reference management), if needed.

• 3+ years of medical writing experience in biotechnology, pharmaceutical, CRO, or clinical research settings required.
• Documented proficiency in scientific writing, editing and communication.
• Understanding of the drug development and approval process
• Knowledge of FDA and ICH guidelines 
• Ability to successfully function in a deadline driven environment
• Project Management skills
• Proven interpersonal, organizational and problem-solving skills in a matrix management environment. 
• Advanced degree (PhD, PharmD, MD, MPH, MS, or equivalent) in life sciences, pharmacy, medicine, or related discipline preferred.

Preferred Qualifications

• 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

Compensation and Benefits:
The expected base salary range for this position is $80,000 - $130,000 annually. Actual compensation will be based on a variety of factors, including but not limited to a candidate’s level qualifications, experience, and skills.
While most offers typically fall within the low to mid-point of the range, we may extend an offer toward the higher end for exceptional candidates whose background and expertise exceeds the requirements of the role.
 
SystImmune is a leading and well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 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, plus 11 paid holidays and MORE.
 
We offer an opportunity for you to learn and grow while making significant contributions to the company’s success.
 
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.