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About the Role

We are seeking individuals to join our Oncology Clinical Science (OCS) team, contributing to the global development of groundbreaking cancer therapies. This role offers opportunities for professional growth through acquiring specialized knowledge, enhancing scientific and communication skills, and strengthening logical thinking within our company's focus area of oncology.

Responsibilities

Collaborate with development-related departments, including the US headquarters, to execute clinical trials as a key member of the clinical trial team.
Engage in discussions regarding development strategies with regulatory authorities.
Participate in submission processes for drug approval.
Assist in the formulation of development strategies, providing input for Japanese clinical trial plans in early and late-stage development protocols.
Support the planning and preparation of documents for consultations with regulatory agencies based on development strategies.
Respond to inquiries from regulatory agencies.
Develop and translate clinical trial protocols, including creating local study protocols from scratch and primarily translating global protocols.
Negotiate with the US headquarters regarding Japan-specific requirements for global protocols.
Create company-standard informed consent forms.
Support and review documents related to clinical trial protocols, such as case report forms and related procedures.
Prepare attachments for Investigational New Drug (IND) applications and respond to inquiries from the Pharmaceuticals and Medical Devices Agency (PMDA).
Confirm patient eligibility.
Conduct medical monitoring of clinical trial data.
Manage serious adverse events (SAEs).
Contribute to the creation and review of the Clinical Study Report (CSR) and the clinical sections of New Drug Applications (NDAs) in collaboration with medical writers.
Respond to inquiries after drug approval.
Prepare for and respond to compliance inspections.
Present at academic conferences and contribute to the writing of publications.

Requirements

Experience in pharmaceutical clinical development (3+ years of oncology experience is desirable).
Experience in creating clinical trial protocols.
Communication skills for close collaboration with internal (domestic and international) related departments and external experts.
English proficiency (TOEIC score of 730 or higher is a guideline).

Skills

Adaptability
Clinical Study Management
Clinical Trial Planning
Data Analysis
Ethical Compliance
Ethical Standards
ICH GCP Guidelines
Medical Writing
Multiple Therapeutic Areas
New Technology Integration
Patient Care
Protocol Development
Regulatory Submissions
Scientific Publications
Therapeutic Knowledge

Location

Japan

Work Type

Hybrid

Experience Level

3+ years of oncology experience desirable

About the Company

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, is a global biopharmaceutical company.
The Oncology Clinical Science department's vision is to create new value as an 'Oncology Clinical Science One Team' by connecting diverse knowledge and experiences, and to contribute to the Oncology development team as a core entity.
The company does not accept unsolicited assistance from search firms.