TOGETHER, WE MAKE CANCER CURABLE
Led by an experienced management team of academic professionals and industry veterans, we have built an integrated cell therapy platform with in-house capabilities that span from target discovery, lead antibody development, clinical studies to commercial-scale manufacturing. Our vision is to become a leading biopharmaceutical company developing globally revolutionary cell therapies to make cancer curable. If you are looking for an opportunity with an innovative and solidly growing company, join us.
Position Summary:
The technical writer will join the Medical Writing (MW) team at CARsgen Therapeutics, based in Houston (Bellaire), TX. The MW team is part of the Regulatory Affairs and Clinical Sciences department, which offers a challenging and rewarding work environment that is diverse, dynamic, and collaborative. The technical writer will support CARsgen’s clinical development in three areas of MW: clinical, regulatory, and scientific communication. Clinical documents include clinical study protocols, informed consent forms, clinical summaries, and investigator brochures. Regulatory documents include regulatory authority briefing books, clinical study reports, and annual reports. Scientific communication includes scientific publications (manuscripts, posters, conference presentations, literature reviews, etc.). The successful candidate will have a strong record of writing and editing in biomedical science. Knowledge of clinical drug/biologics development is preferred.
Key Responsibilities:
l Write, edit, and communicate clinical/scientific content in English clearly, concisely, and effectively
l Gather, organize, format, review, and present information appropriately for the target audience
l Critically analyze, synthesize, and present complex information in well-constructed documents from a variety of sources, including research documents and tables, figures, and listings
l Integrate cross-functional input, ensure documents communicate necessary information, and facilitate issue resolution with revisions
l Ensure compliance of documentation to GCP, SOPs, and external guidelines
l Document project management: Develop, coordinate, and manage timelines, communicating with team members to maintain awareness of expectations, responsibilities, and review timelines
l Prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines and shifting priorities
l Follow established document management systems, providing feedback for operational improvements
l Provide professional input on and/or QC documents prepared by others
Qualifications & Requirements:
l MS (required) in biomedical science. PhD training in biomedical science preferred.
l 2-3 years’ experience (1-2 years with PhD) in medical writing and scientific communication as demonstrated by scientific publications (required). Experience in cancer immunotherapy preferred.
l Strong written, verbal, and data visualization communication skills
l Strong technical writing and editing skills, including grammar and usage, punctuation, sentence structure, medical terminology, tables and graphs, statistics, and medical ethics
l Strong technical expertise in Microsoft Office (especially Word, SharePoint, PowerPoint, and Excel) and Adobe Acrobat DC
l Knowledge of medical/scientific writing standards, practices, and tools including style guides, journal instructions for authors, and templates
l Knowledge of or willingness to learn global regulatory requirements and guidance associated with clinical regulatory document preparation and submissions
l Independently motivated and customer-oriented with strong relationship management skills
l Ability to work both independently and collaboratively
Supervisory Requirement:
l Not applicable.
Frequent Contacts:
l Internal contacts or departments: regulatory affairs, clinical research scientists, translational scientist, clinical trial project managers, CMC
l External contacts: regulatory submission vendors, contract medical writers, etc.
CARsgen Therapeutics is a clinical-stage immune-oncology biotech company traded on the Hong Kong stock exchange number 2171.HK. The company's leading programs set it apart from other CAR-T companies by focusing on the development of novel therapies for solid tumor treatment. CARsgen developed the first-in-human CAR-GPC3 T cell therapy against r/r HCC and the first-in-human CAR-Claudin18.2 T cell therapy against r/r gastric and pancreatic cancer. The company will provide its employee a competitive compensation plan, including base salary, 401K, insurances, equity option, bonus, PTO, etc.
Equal Employment Opportunity Policy
CARsgen Therapeutics Corporation provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.