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 several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

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.

Education & Experience

Must possess a Bachelor’s 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.

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.