The Clinical Trial Specialist will report to the Associate Director of Clinical Transparency & Data Sharing, facilitate Otsuka’s clinical trial results disclosures process, and support other related clinical transparency initiatives as needed. The position will report out of either Rockville, MD or Princeton, NJ.
The Clinical Transparency Specialist will:
*Facilitate the drafting, review and timely disclosure of clinical study results
*Maintain complex study tracking sheet in excel, or Otsuka clinical trials disclosure system
*Maintain multiple workflows in advance of regulatory deadlines, which include:
*Manage multiple comments received from study teams;
*Facilitate communications between the medical writing vendor and study teams to ensure all review comments are incorporated/addressed in a timely manner
*Provide weekly status reports and escalate potential issues to management
*Ability to become subject matter expert about disclosure systems
*Assist in project management on all clinical transparency initiatives led by the Clinical Disclosure and Data Sharing (CDADS) group. These initiatives include:
1. Processing, documenting and SharePoint management of redaction procedures
2. Supporting process development of a Lay Summary Results Program in collaboration with Clinical Management by assisting with preparation of meeting materials, scheduling meetings, recording meeting minutes, etc.
3. Ensuring processes and procedures are aligned with all global clinical transparency regulations, industry guidelines and best practices
4. Drafting annual reports.
• Bachelor’s Degree required
• Detail-oriented and process driven individual with strong time management skills
• Ability to work independently to research required information from available online and internal resources in a fast paced and professional work environment
• Familiarity with Clinical Study Reports (CSR) and/or drug development phases preferred
Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a “big venture” company at heart, applying a youthful spirit of creativity in everything it does.
Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 45,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.