Roles & Responsibilities
- Medical writing: Provide scientific/clinical input into and assist in the development, maintenance and review of clinical documents and specified regulatory submission documents including clinical protocol, investigator brochures, informed consent form, annual IND reports, clinical study reports, manuscripts, and different scientific/clinical presentations and subsequent amendments.
- Support the development of publication and scientific/clinical meeting strategy; prepare essential content and coordinate authorship of publications (abstracts, posters, manuscripts, presentations).
- Manage, update and maintain company’s clinical/scientific materials, reference library and Dataroom
- Ensure high quality document preparation for clinical regulatory submission, comment resolution/incorporation, and document finalization.
- Generate, analyses, interpretate scientific/clinical narratives to support clinical, regulatory, and external communication activities.
- Conducts systematic literature reviews, cohesively collates relevant clinical and scientific information to obtain strategic input into clinical program development, including target diseases/patient populations, draft labels, competitive landscape, and market development
- Provide relevant scientific/clinical information to subject matter experts (SMEs) from other functions (e.g Product Development & Manufacturing Teams) to support new product development.
- Maintaining a deep working knowledge of oncology and immuno-oncology fields, as well as maintaining working relationships with investigators and other external experts in the field.
- Attend clinical/scientific meetings to meet with thought leaders and investigators, as well as to keep up-to-date knowledge in the field.
- Identify and support internal physicians interactions with key opinion leaders (KOLs) and academic organizations to assure incorporation of latest clinical thinking and guidelines into clinical development plans
- Support internal physician, in conjunction with Clinical Operations staff, for ongoing clinical trials; this includes working with investigators and clinical site staff to assess subject eligibility, discuss and resolve patient safety issues, and address any clinical issues related to the conduct of the trial. Work with investigators to fully comply with safety reporting requirements and assessments of relatedness of adverse events to study medication(s).
- Support internal physician on protocol training to investigators and clinical site staff as part of a site initiation visit, investigator meeting, or other study-related meeting.
Required Qualifications & Experience:
- Healthcare-related Doctoral or advanced degree (e.g., PhD, MD, PharmD) in life sciences, pharmacology, biomedical engineering, biostatistics/ epidemiology, clinical research, or other related fields.
- Medical writing experience in Medical Information/Medical Communications/regulatory submissions within the pharmaceutical or biotech industry is highly preferred
- Strong technical/ scientific/clinical knowledge on immunology, oncology and/or immunotherapies (antibody, CAR-T, TCR-T cell therapies e.g.) is highly preferred
- Understanding of laboratory techniques in one or more of the following areas: Flow cytometry, PCR, sequencing, serology, microbiology, clinical virology, immunohistochemistry, immunological assays.
- Experience and knowledge of clinical research/development, Good Clinical Practices (GCP) and/or regulatory requirements for the conduct of clinical trials preferred
- Ability to conduct database/literature searches with critical analytical thinking and problem-solving skills using PUBMED, EMBASE, MEDLINE etc.
- Proficiency with common word processing tools.
- Possess strong interpersonal skills and ability to collaborate effectively with KOLs and various stakeholders throughout the organization.
- Excellent organizational, communication, and project/process management skills to drive several high-impact projects simultaneously.
- Demonstrates positive interactions with others and conducts all work in an ethical manner.
- English speaking with writing skills exemplary of excellent written and oral communication skills
- Bilingual in English and Chinese (written and oral) is preferred.
