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Project Manager
Santa Clara, California  |  Remote, Onsite
Contract Position
It appears that you have already applied to this job.
Applied on August 1, 2021
Job Id #48657 Posted June 30, 2021


Description:

  • This position is NonExempt.
  • Hours over 40 will be paid at Time and a Half.
  • 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
  • In this role, you will provide technical and strategic expertise at the post-market phase of product life cycles.
  • Writes/manages Periodic Safety Update Report (PSUR) and Post-Market Surveillance (PMS) Report and interacts with various cross-functional teams in order to assist in strategy, plans, and project deliverables.
  • Must be able to effectively manage multiple projects and timelines.
  • Independently creates and maintains PSURs and PMS Reports for Abbott products. Maintain thorough knowledge of assigned products. Identify appropriate sources of relevant data, interpret, evaluate and incorporate information from various sources including literature, clinical data, and medical references.
  • Creates, manages, or participates in PSUR/PMS Report timelines by selecting providers or external medical writers, managing vendor contracts as requested, and ensuring expenditures are within budgetary guidelines
  • Oversees CROs, actively manages timelines and project delays/risks, develops scenario’s and recommendations for management.
  • Facilitates communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, Product Performance Group (PPG), Sales and Marketing, Quality Engineering, Clinical Affairs, Risk Management, Project Management, as well as external vendors such as CROs, Medical Writers and Reviewers).
  • Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process.
  • Maintains update-to-date understanding and experience of clinical / PMS data and risk management.
  • Develops and maintains PSUR/PMS Report DOP/SOP and associated documentation, provides input to cross-departmental SOPs and DOPs as needed.
  • Minimum Education: Bachelor's degree required, advanced degree preferred.
  • Degree in the sciences, medicine, or similar discipline highly preferred.
  • Minimum of 5+years of related work experience with a complete understanding of specified fun

Horizontal is proud to be an Equal Opportunity and Affirmative Action Employer. We seek to provide employment opportunities to talented, qualified candidates regardless of race, color, sex/gender including gender identity and/or expression, national origin, religion, sexual orientation, disability, marital status, citizen status, veteran status, or any other protected classification under federal, state or local law.

In addition, Horizontal will provide reasonable accommodations for qualified individuals with disabilities. If you need to request a reasonable accommodation in order to complete the application or interview process, please contact hr@horizontal.com.

All applicants applying must be legally authorized to work in the country of employment.

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Horizontal is proud to be an Equal Employment Opportunity/Affirmative Action Employer providing a drug-free workplace.

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