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Project Manager II
Job Description
Target PR Range: 44-54/hr
*Depending on experience
Experience/Skills:
-Bachelors' degree required in a scientific or technical field (Chemistry, Pharmacy, Biology, Microbiology or Engineering) required.
-Minimum of 6+ years of risk management industry experience in a regulated environment.
-Effective communication skills, with an ability to work and influence cross-functionally.
-Thorough understanding of polices, regulations, standards, and best practices of risk management. The scope of responsibilities is broad and requires the ability to communicate, understand and direct individuals in highly specialized risk management background.
-Excellent organizational skills, attention to detail, and strong analytical skills.
Preferred experience:
-Experience in two or more of the following areas: Quality Assurance, Compliance, Regulatory, Clinical Operation, Pharmacovigilance, Manufacturing, or Combination products or Medical devices.
-Experience using risk management software.
Job Description:
Purpose: Primarily responsible for the oversight, execution, deployment and continuous improvement of R&D Quality System to ensure appropriate GxP alignment and compliance to evolving regulations.
Responsibilities:
-Conduct risk assessments, including the identification of hazards, estimation of risks, and evaluation of risk mitigation strategies.
-Work closely with the Quality Risk Management Quality System Owner and support other related Quality System processes as needed.
-Collaborate with cross-functional teams to develop and implement risk mitigation plans.
-Stay up-to-date with industry trends, regulatory changes, and emerging risks, and proactively recommend improvements to the R&D Quality Risk Management Program.
-Maintain deep understanding of the Quality Risk Management process, including linkages and interactions of all impacted functional areas.
Manages/directs the activities and people associated with small to large scale projects with a focus on any or several non-IT business applications and disciplines. Manage/direct all facets of single or multiple, multidimensional, mission-critical projects through the Full Project Life Cycle. Collaborate/work with project sponsors, business units and users to identify project scope and focus, develop or monitor project initiatives, implement project requirements/plans/processes/tools, assign/guide/monitor project staff, and assure project success. Deliver quality project solutions to business problems or issues within defined budgets and/or timelines. Provide expert project guidance/support proactively through project completion. Provide tracking, reporting, and presentation to management and users. 7+ years experience
*CO/NYC candidates might not be considered
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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