[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.ResponsibilitiesManage & 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 SharingInvestigate & gather global requirements & implement processes for ensuring accuracy, consistency, & alignment of clinical data/information made publicWork globally & cross functionally to align procedures & ensure appropriate complianceSkillsMust possess a Bachelor's degreeMust 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 trialMust have 2 years preparing & presenting, orally & in writing, presentations to peers, leadership & business stakeholdersMust have 2 years working in collaborative, cross-functional teamsMust have 1 year serving as a project manager in the pharmaceutical industryBenefitsPaid time off (vacation, holidays, sick)Medical/dental/vision insurance401(k) to eligible employeesEligible to participate in our short-term and long-term incentive programsCompany OverviewAt Allergan Aesthetics, an AbbVie company, we develop, manufacture, and market a portfolio of leading aesthetics brands and products. It was founded in undefined, and is headquartered in Irvine, California, USA, with a workforce of 1001-5000 employees. Its website is https://www.allerganaesthetics.com.