[Remote] Project Manager CTIS, Trial Disclosure (Drugs & Devices)

Note: The job is a remote job and is open to candidates in USA. AbbVie is a global biopharmaceutical company focused on discovering and delivering innovative medicines. They are seeking a Project Manager for CTIS, Trial Disclosure to manage and oversee the global public disclosure of clinical trial data in compliance with various regulations and commitments.

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

Skills

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

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k) to eligible employees
• Eligible to participate in our short-term and long-term incentive programs

Company Overview