Project Manager CTIS, Trial Disclosure (Drugs & Devices)

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 Bachelor’s degree. 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.
• Experience: Must have 2 years: preparing & presenting, orally & in writing, presentations to peers, leadership & business stakeholders; & working in collaborative, cross-functional teams. Must have 1 year serving as a project manager in the pharmaceutical industry.

Additional Information

• Salary Range: $153,712.00 - $157,500.00 per year.
• Apply online at https://careers.abbvie.com/en or send resume to Job.opportunity.abbvie@abbvie.com. Refer to Req ID: REF49814Y
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term and long-term incentive programs.