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 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:

1. preparing & presenting orally & in writing presentations to peers leadership & business stakeholders; &
2. 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: $153712.00 - $157500.00 per year.

Apply online at or send resume to . 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.

AbbVie is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies 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.

AbbVie 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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

Yes

Employment Type :

Full-time