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.
...aggregate distribution network covers Florida, Southern Mississippi, South Carolina, and Alabama. Position Overview The Plant Maintenance position will be responsible for daily maintenance and repair of the plant as well as other miscellaneous work that needs to be...
...sitters) Must have: candidates without these skills will not be considered for the role. BLS, ACLS, NRP 2 years of current acute care Hospital RRT experience Preferred or nice to have: candidates with these skills will be considered first. Trauma experience Director prefer...
...national network of Serenity providers and clinical leadership Annual provider retreats to exotic locations like Maui and the Bahamas The Role As a psychiatric nurse practitioner at Serenity, youll practice at the top of your license in a supportive, innovative...
...Unit Information: CV Services (74613) Cath Lab/ EP Lab CVT Facility: HCA FLORIDA JFK HOSPITAL Address: 5301 South Congress Avenue Floor: 2 Building: Main Cost Center: 74613 General Information Tell us about the unit(s): Number of Beds: 3 cath rooms and 4 ep rooms Number...
...determined by the department. Hiring Range TBD Based Upon Qualifications Relocation Offered No Visa Sponsorship Provided No Background Check For position finalists, employment with the University will require successful completion of a background check Child...