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:
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.
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 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. SystImmune offers a comprehensive benefits package.
SystImmune is an Equal Opportunity Employer. We welcome diverse talent and encourage all qualified applicants to apply.
...Fine Homes Sothebys International Realty is seeking aMultimedia Designer to create compelling, digital-first creative across video,... ...initiatives, and agent support materials. Produce high-quality video content, including storyboarding, editing, motion graphics, and final...
...team by promoting from within many of our employees have built their careers with us. What you will do: Repair and maintain industrial equipment conveying systems, and major machine centers. Able to read and understand drawings and printed instructions. Must...
Job Description Solomon Page is seeking a travel nurse RN Nursery for a travel nursing job in Concord, Massachusetts. Job Description & Requirements ~ Specialty: Nursery ~ Discipline: RN ~ Start Date: 02/09/2026~ Duration: 13 weeks ~36 hours per week ...
...Job Description Job Description Guard Shack / Security Person We are looking for a Guard Shack / Security Person in Green Bay, WI.As a Security Officer, you will be part of the Security Team supporting Safety & Operations, logging incoming and outgoing freight,...
...Job Title: Graphic Designer Location: Hybrid (Huntersville, NC) Hours: Part-Time, 1530 hours per week About Everblue Everblue is a mission-driven company dedicated to transforming careers and improving organizational efficiency. We provide training and certification...