Medical Writer / Sr. Medical Writer

Medical Writer/Sr. Medical Writer

Redmond, WA

SystImmune Inc. is a clinical-stage biopharmaceutical company located in Redmond, WA. 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 several assets in various stages of clinical trials for solid tumor and hematologic indications. Alongside ongoing clinical trials, SystImmune has a strong preclinical pipeline of potential cancer therapeutics in the discovery or IND-enabling stages, representing cutting-edge biologics development.

Summaries:

SystImmune, Inc is currently seeking a medical writer who 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.

Essential Duties and 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.
Act as a documentation specialist in clinical trial teams.
Follow and track clinical documentation milestones.
Write/edit other strategic documents, as required.

Required Skills & Qualifications:

Master's degree in a life sciences discipline or at least 10 years of 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 major documents (eg,. protocols, CSRs, ISE, ISS, and Clinical Overview etc.).
Knowledge of accounting principles and practices, financial regulations, and tax laws in the biopharmaceutical industry.
Experience with public company reporting and compliance requirements.

Preferred Qualifications:

Advanced Scientific Degree preferred with at least 8 years of relevant writing experience.
Advanced knowledge of drug development and regulatory requirements to guide document organization.
Project management experience including using negotiating and influence skills to ensure document timelines are met while maintaining high quality.
Proven experience leading the regulatory writing effort for an IND.

SystImmune is a stable, 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 10 paid holidays and MORE.

SystImmune is an Equal Opportunity Employer. Interested applicants should send their CV and cover letter to [email protected]