Medical Writer
Listed on 2026-01-30
-
Healthcare
Medical Imaging
The medical writer will be responsible for the management and oversight of assigned medical writing projects, including clinical study protocols and reports, investigational new drug applications (INDs), investigator brochures, reviewing informed consent forms and regulatory briefing materials. They will be accountable for ensuring that all documents are written according to established templates and guidance, and that they are of the highest quality with respect to scientific content, organization, accuracy, regulatory guidelines, clarity of presentation, and structure.
Key Responsibilities- 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 (eg,. protocols, CSRs, ISE, ISS, and Clinical Overview etc.)
- 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
The hiring pay range for this position is $80,000 - $130,000 per year based on skills, education, and experience relevant to the role.
Syst Immune is a leading and well-funded clinical-stage biopharmaceutical company located in Redmond, 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).
Syst Immune has multiple assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, Syst Immune has a robust preclinical pipeline of potential cancer therapeutics in the discovery or 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. Syst Immune offers a comprehensive benefits package.
Syst Immune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
#J-18808-Ljbffr(If this job is in fact in your jurisdiction, then you may be using a Proxy or VPN to access this site, and to progress further, you should change your connectivity to another mobile device or PC).