Associate, CDD-J

Sep 20, 2021

Job Description

1) Provide clinical input for all clinical deliverables in the assigned trial including post approval commitment study. Clinical deliverables may include clinical sections of individual protocol/related documents, clinical data review, interim/final study report (CSR), trial related clinical components of regulatory documents/registration dossiers, and publications.
2) Lead discussions regarding assigned trial and study, in Japan Project Team (JPT), Japan Submission Team(JST), Clinical Trial Team(CTT), Local Trial Team(LTT), Post-marketing Study Team (PST), and Team for Re-Examination Excellence (TREE)
3) Contribute to development of clinical sections of project level documents (e.g.,Investigator’s Brochures, briefing books, safety updates, submission dossiers, J-RMP, Re-examination application dossiers, a report for lifting of “all patient surveillance” as approval condition and responses to Health Authorities)
4) Create study concept in collaboration with JPCH.
5) Drive execution of the clinical program in partnership with responsible line functions including CSMs, Global Trial Directors (GTDs), PMS TMa, if applicable
6) Ensure ongoing medical and scientific data review of the assigned trial including post approval commitment study
7) Support overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety in Japan
8) As a clinical expert, support the JPCH in interactions with Japan external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring
boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., JPT, JBT, CTT, Research, Translational Medicine, Japan Medical Affairs, Marketing, HE&OR, PS-J), and internal decision boards
9) Provide on-boarding, training, & mentoring support
Major Activities
10) Contribute to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for
medical/ scientific training
11) Contribute to initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)
12) Comply with PMD Act(Pharmaceutical and Medical Device Act/GPSP (Good Post-marketing Study Practice), SOPs and other related procedures (including performing all provided training)
13) Ensure adequate reporting of adverse events / technical complaint /compliance issue in accordance with company procedures
14) 100% timely delivery of all training requirements including compliance

Minimum Requirements

 Relevant degree in life sciences/healthcare (or clinically
relevant degree) is required

Experience/Professional requirement:
 ≥ 3 years of involvement in clinical research or drug
development in an academic or industry environment
spanning clinical activities in Phases I through IV, and PMS. ≥ 3 years of contribution and accomplishment in all aspects of conducting clinical trials or PMS (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry.
 Advanced knowledge of assigned therapeutic area
 Demonstrated ability to establish strong scientific
partnership with key stakeholders
 Thorough knowledge of GCP and GPSP, clinical trial/PMS design, statistical analysis methodology, and regulatory/ clinical development process.
 Excellent communication skills, written and oral
 Strong interpersonal skills
 Excellent negotiation and conflict resolution skills

English Skill:
 Capable oral and written English
Global Drug Development
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Associate, CDD-J

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