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Project Manager
Santa Clara, California  |  Onsite
Contract Position
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Applied on June 24, 2021
Job Id #47385 Posted May 4, 2021


Description:

Global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Job Description

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 functional area, or an equivalent combination of education and work experience.
  • May consider candidates with less experiences.

Minimum Experience / Training Requirements:

  • Knowledge of PSURs / PMS Report.
  • Experience writing CERs and related documents in accordance with MDR 2017/745 and MEDDEV 2.7/1 Rev 4.
  • Understanding of regulations, standards and guidelines related to medical devices clinical studies, and quality systems, including: MDD 93/42/EEC; AIMDD 90/385/EEC; MDR 2017/745; MEDDEV 2.7/1 Rev. 4; ISO 14971; ISO 14155; ISO 13485.
  • Effective written, verbal and presentation skills in the area of technical/clinical applications.
  • Familiar with IMDRF terminology/codes and adverse event reporting is preferred
  • Experience with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), or Good Manufacturing Procedures (GMP) is preferred.
  • Project management experience.
  • 3-5+ years of experience in clinical research, quality systems, or regulatory experience in medical device or pharmaceuticals industry
  • Demonstrated ability to identify and adapt to shifting priorities and competing demands.
  • Highly-developed interpersonal skills, and strong attention to detail.
  • May consider candidates with less experiences.

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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