Director, Medical Writing

Director, Medical Writing


Job Title: Director, Medical Writing
FLSA Status: Full-Time/Exempt
Department: Clinical Development
Date: February 16, 2022
Manager: Executive Director, Clinical Development
Location: Pittsburgh, PA or Remote
Job Code: BIO-22-025

BlueSphere Bio was founded to deploy its novel TCXpress™ technology to unlock the potential of personalized T cell therapy for the treatment of cancer by harnessing the unique specificity of each patient’s T cells for the molecular fingerprint of each patient’s cancer.

Our trailblazing, proprietary TCXpress platform is an elegant, rapid approach that exploits the patient’s immune defenses to attack their cancer specifically and is designed to leave normal tissues untouched, thereby reducing harmful side effects.

The TCXpress™ platform and its implementation will allow us to deliver rapid, personalized T cell treatments for various cancer indications.

BlueSphere Bio is seeking a full-time Medical Writer with 5+ years of experience in medical writing in a pharmaceutical or biotech company, with a preference for experience in the startup environment. The ideal candidate will have experience with the oncology therapeutic area, preferably with cell therapy experience (adoptive cell transfer and/or CAR-T). The Medical Writer will be accountable for the medical and scientific writing to support submissions from first in human studies through product registration. This position is remote and can be based anywhere in the U.S.

Duties and Responsibilities
• Write and edit clinical study reports, protocols, investigators’ brochures, informed consents, integrated summaries of safety, integrated summaries of efficacy, patient narratives, study reports, briefing books, regulatory agency responses, and other documents for national and international studies/submissions.
• Coordinate all aspects of medical writing for the current pipeline in collaboration with each functional group to ensure consistency of messaging.
• Collaborate with teams to create all documents for submission to health authorities.
• Provides leadership/strategy at the therapeutic area level for documents and complex submissions
• Supervise activities of any external/ contract medical writers, as needed.
• Author SOPs, process documents, global policies, author guidance, and other documents to support the organization.
• Ensure documents are accurate, complete, and adhere to applicable regulatory guidelines and departmental and editorial standards.
• Assist in preparing abstracts, posters, and slides for oral presentations to external audiences.
• Other duties as assigned

Qualifications and Work Experience
• Master’s, Ph.D., or PharmD degree in basic or applied science areas or immunology preferred
• Five plus (5+) years of experience in medical writing in a pharmaceutical or biotech company, with experience with oncology therapeutic area, preferably with cell therapy experience (i.e., adoptive cell transfer and/or CAR-T).
• Experience with M.S. Project, MS Office Suite, Adobe Acrobat Professional, and other digital platforms (i.e., SharePoint).
• Expert knowledge of Regulatory requirements and ICH GCP guidelines
• Experience working with the Common Technical Document (CTD) format.
• Expert knowledge of current industry practices/regulatory requirements related to medical writing
• Clear, effective, and concise verbal and written communication skills
• Meticulous attention to detail and excellent organizational skills
• Works independently and collaboratively in a cross-functional team
• Ability to triage and prioritize workload according to timelines and escalate bottlenecks
• Excellent interpersonal skills with demonstrated ability to work in a team environment and interact effectively with people at many levels of any organization.

BlueSphere Bio is an Equal Opportunity Employer (EOE) and offers employment opportunities to all qualified persons regardless of race, color, religion, sex, age, national origin or ancestry, physical or mental disability (except where physical or mental abilities are a bona fide occupational requirement), veteran status, marital status, familial status, sexual orientation, HIV-positive status, possession of the sickle cell trait, genetic characteristics, political views, and any other basis protected by federal, state or local laws.

Please send a cover letter to apply for this position (including job code) and CV/Resume. Internal candidates interested in this opportunity should submit their CV/Resume within 2-weeks of the posting date above and explain why you are interested in this position.

BlueSphere Bio