COMPANY OVERVIEW
Currently our client (Pharmaceutical Company) is looking for Japanese Bilingual Clinical Development Associate Director/ Director within their organization.
This position needs to commute to office every day in New Jersey.
RESPONSIBILITIES
Work on the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key documents in conjunction with other line functions and with minimal guidance
Work with cross-functional Teams for assigned trials, working with other team members to achieve high-quality study execution
Prepare regulatory documents in support of regulatory submissions, including clinical section of safety reports and annual reports for assigned trials.
Provides scientific and clinical input to study-related documents and analysis plans.
Acts as liaison between Clinical Development and other internal groups (e.g., Regulatory Affairs and others) for assigned studies.
Presents outside medical personnel in the development of clinical protocols and study results.
Performs other duties as assigned related to other aspects of Clinical Development
REQUIREMENTS
Strong oral and written communication skills (Both in Japanese and English)
Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
Clinical research experience in the United States and experience interacting with regulatory authorities
Working familiarity with analysis of research data, biostatistics, pharmacology and international standards for Good Clinical Practice (GCP), clinical study design, preparation of manuscripts, abstract/posters, and oral presentations, overall drug/device clinical development
MD, DO, PHD or master’s degree from accredited colleges.
2-3 years of basic or clinical research experience in industry setting.
SALARY
Salary range for this role is $150,000- $200,000 (Depending on the candidate experiences)
BENEFITS
Medical, Dental, Vision, 401K and others.
We sincerely apologize, but due to a high volume of applicants, only those who successfully pass the initial screening will be contacted. We truly appreciate your understanding.
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