Project Manager CTIS, Trial Disclosure (Drugs & Devices)

Job Description

Key Responsibilities

• Manage & provide oversight for global public disclosure of clinical trial data/information in compliance with various requirements/commitments, including, but not limited to, CTIS, EUDAMED, EU Clinical Trial Regulation, EU Medical Device Regulation, EU In-vitro Device Regulation, EMA Policies 0043 & 0070, & PhRMA/EFPIA Principles for Responsible Clinical Trial Data Sharing.
• Investigate & gather global requirements & implement processes for ensuring accuracy, consistency, & alignment of clinical data/information made public.
• Work globally & cross functionally to align procedures & ensure appropriate compliance.

Qualifications

• Education & Experience
• Must possess a Bachelors degree.
• Of the work experience required, must have 4 years submitting clinical trial registrations on behalf of clinical trial sponsors & managing communications with the regulatory authorities to successfully make public a record (i.e. registration) of an authorized clinical trial.
• Of the experience required, must have 2 years:
• preparing & presenting, orally & in writing, presentations to peers, leadership & business stakeholders;
• working in collaborative, cross-functional teams.
• Of experience required, must have 1 year serving as a project manager in the pharmaceutical industry.
• Work experience may be gained concurrently.

Additional Information

• Salary Range: $153,712.00 - $157,500.00 per year.
• To apply, visit https://careers.abbvie.com/en or send resume to Job.opportunity.abbvie@abbvie.com. Refer to Req ID:REF49814Y.