Medical Writer
About The Position
SystImmune, Inc. is a biopharmaceutical company focused on treating cancer through developing novel therapeutic multi-specific antibodies and antibody-drug conjugates (ADCs). 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.
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 (eg,. protocols, CSRs, ISE, ISS, and Clinical Overview etc.)
Nice To Haves
- 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
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
Benefits
- Comprehensive benefits package
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
