SystImmune 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). 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 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:
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
Required Qualifications:
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.)
Preferred Qualifications:
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 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.
...Outside Sales Representative (Roofing & Exteriors) $100K Uncapped Krech Exteriors Twin Cities MN If you can sell youll make serious money here. This is a high-performance commission-driven role for someone who wants to win compete and get paid for it. No...
...Company Overview Dropoff is a same-day, last mile delivery service that enables businesses across industries to meet rising expectations... ...Advantages of Contracting with Dropoff MUST OWN A CARGO VAN, WE DO NOT SUPPLY VEHICLES Paid by the delivery Drive...
...who have been withheld may file an appeal with the State Personnel Board. The minimum qualifications can be found in the Aviation Officer II (Flight Operations) classification specifications. Benefits Benefit information can be found on the CalHR website and...
.... Customers are the heart of our business, and we work every day to help grow... ...complex assignments depending on level.Minimum Qualifications * A Bachelors degree in Accounting, Finance, Economics... ...business degree is required* Entry level position where some work experience...
...As a laundry attendant, your main responsibility is to maintain a constant supply of clean linens and towels for the hotel. Other responsibilities include assisting with cleaning and maintaining public areas of the hotel, assisting room/suite attendants with general cleaning...