|Compliance Manager - Clinical Transparency|
Company: Otsuka Pharmaceuticals
Location: Rockville, MD
Employment Type: Full Time
Date Posted: 05/11/2021
Expire Date: 06/11/2021
Job Categories: Other
Compliance Manager - Clinical Transparency|
Otsuka America Pharmaceutical, Inc. (Otsuka) is looking for a Compliance Manager to join the Clinical Transparency team within Ethics & Compliance. Otsuka seeks business professionals who are highly motivated and collaborative. The Compliance Manager will report to the Clinical Transparency lead. This position may be remote, or located in either our Rockville, MD or Princeton, NJ offices.
The Compliance Manager will be responsible for day-to-day operations of the Clinical Transparency function, including the coordination of and updates to Otsuka's clinical trial disclosures. The candidate will also be the subject matter expert and a primary point of contact for the Clinical Transparency group's ongoing projects. This role provides an opportunity to collaborate across functions and levels of leadership on initiatives that vary in scope. The role requires an ability to work with limited supervision and an understanding of when to act independently or appropriately escalate issues. The role also requires an understanding of procedural, data, and systems governance and a demonstrated ability to assess risk and support the management of operations to achieve outcomes that are compliant with applicable regulations and industry best practices.
The specific responsibilities of the Compliance Manager, Clinical Transparency are:
1) Facilitating the drafting, review, and timely disclosure of clinical study results on clinicaltrials.gov and EudraCT, and:
a) Tracking and maintaining the progress of related study documents in either Excel and/or Otsuka's clinical trials disclosure system(s);
b) Maintaining and coordinating multiple workflows in advance of regulatory deadlines; and
c) Providing weekly status reports and escalating potential issues to management.
2) Lead and/or support the project management on all initiatives within Clinical Transparency, including:
a) Processing, documenting and managing redaction procedures;
b) Supporting the development of and updates to procedural documents;
c) Ensuring processes and procedures are aligned with all global clinical transparency regulations, industry guidelines, and best practices;
d) Conducting regular meetings to ensure all workstreams remain on track to meet the established deadlines; and
e) Managing vendor relationships including processing contracts, invoices and budget.
* BS or BA in a science related field
* Project management experience
* Detail-oriented and process driven with excellent time management skills
* Excellent communication skills
* Proficiency in MS Office Suite and an ability to adapt to new systems
* Experience in the biotech and/or pharmaceutical industry
* Desire to work in a fast-paced and regulatory governed environment
* Demonstrated ability to develop efficient strategies and tactics to meet project goals and deadlines
* Strong time-management and organizational skills
* Familiarity with Clinical Study Reports (CSR) and drug development
* Knowledge of general clinical trial transparency regulations
* Prior experience with clinical trial results disclosure and data sharing requirements
* Proven ability to analyze and propose solutions to problems
Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.
Disclaimer: 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.
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