Project Manager CTIS, Trial Disclosure; Drugs & Devices

Company Description

Abb Vie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across key therapeutic areas such as immunology, oncology, neuroscience, and eye care, and through our Allergan Aesthetics portfolio. For more information, visit

• Manage and provide oversight for global public disclosure of clinical trial data and information in compliance with various requirements and commitments, including CTIS, EUDAMED, EU Clinical Trial Regulation, EU Medical Device Regulation, EU In‑vitro Device Regulation, EMA Policies 0043 & 0070, and PhRMA/EFPIA Principles for Responsible Clinical Trial Data Sharing.
• Investigate and gather global requirements and implement processes for ensuring accuracy, consistency, and alignment of clinical data and information made public.
• Work globally and cross‑functionally to align procedures and ensure appropriate compliance.

• Must possess a bachelor’s degree.
• Must have 4 years of experience submitting clinical trial registrations on behalf of sponsors and managing communications with regulatory authorities to successfully publish a record of an authorized clinical trial.
• Must have 2 years of experience preparing and presenting—both orally and in writing—presentations to peers, leadership, and business stakeholders; and working in collaborative, cross‑functional teams.
• Must have 1 year serving as a project manager in the pharmaceutical industry.

Work experience may be gained concurrently.

Salary Range: $ – $ per year.

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.

Abb Vie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion. It is Abb Vie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit

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