Mgr Clinical Trial Info Disclosure

Job Summary

The Clinical Trial Information Disclosure Manager leads strategic and operational company activities to comply with the EFPIA-PhRMA and other regional principles. A member of the Global Clinical Trial Disclosure Committee & Office. Leads the company's current disclosure requirements and participates in the strategic planning for future change. Subject matter expert on global clinical trial registration and summary result posting requirements.

Responsibilities

Leadership of strategic and operational company initiatives to comply with the EFPIA-PhRMA principles and other regional principles, including implementation of EMA Policy 0070 (and other external policies) and its subsequent compliance.
Subject matter expert on global clinical trial registration and summary result posting requirements.

• Monitors & assesses these requirements, creates compliant processes and provides advice to project & functional teams, as needed. Proactively identifies and manages risks.

• Builds close working relationships with key company stakeholders across functions, as well as building a network with key staff members including senior management, the global functional leads, Regulatory Intelligence, and Policy and company trade association group members.
• Training & raises awareness of the topic of clinical trial information disclosure within the company globally. Designs and implements programs to deliver sustainable learning.
• Provides oversight for the end to end processes across the trial disclosure area.
• Manages vendors and CROs providing trial disclosure services to Daiichi Sankyo.
• Effectively communicates internal compliance metrics within Daiichi Sankyo.

Member of Global Clinical Trial Disclosure Committee & Office.

• Act as the lead Data Sharing Coordinator from external sources and internal SMEs.
• Ensure prompt responses to queries for information or documents from external sources.
• Ensure prompt and thorough review of requests for de-identified company clinical trial data.
• Ensure company clinical trial data on the SAS/ideaPoint site is current.
• Lead / co-lead global process development and procedural document drafting, as appropriate.
• If necessary, substitutes for the Director at trial disclosure related meetings.
• Drafting agendas and minutes, leading actions as appropriate and ensuring deliverables are completed on time and within budget.

Physical and/or Travel Requirements:

Standard office based physical demands, and some international travel for internal and external workshops / interactions with external regulators, industry bodies and key stakeholders. Ability to travel within US, and to the EU & Japan. 10 - 15%

Qualifications:

• Degree (Bachelor, State Examination, Diploma) in pharmacy, biology, chemistry, medicine, or equivalent; Master or PhD preferred.

• About 4-6 years' experience in the pharmaceutical industry, experience in the area of clinical trial information disclosure highly desirable.
• Working knowledge of key global laws, regulations and guidelines relating to clinical trial data disclosure is desirable.
• Good general knowledge of key global pharmaceutical legislation.

• Experience of working in a global, international regulatory environment and experience in interacting with regulatory authorities. Experience working within a global team framework and a multi‐cultural environment.
• Excellent interpersonal skills; ability to work across functions in a multinational organization to accomplish results. Be "detailed‐oriented"; well organized and self‐motivated; high ethical behavior, excellent written and oral communication skills. Excellent influencing skills
• Excellent research skills. Understanding of drug development and regulatory processes.
• Experience of interactions with FDA, EMA and/ or EU National Agencies and EMA as well as with industry associations is desirable.
• Ability to provide technical input, proven ability to plan, coordinate and lead activities simultaneously on multiple projects.

Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Job Title
Mgr Clinical Trial Info Disclosure

City
Basking Ridge

Functional Area
Regulatory Management Operations

State
New Jersey