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Project Manager
Abbott Park, Illinois  |  Onsite
Contract Position
It appears that you have already applied to this job.
Applied on January 16, 2022
Job Id #52639 Posted December 9, 2021


Description:

  • Project management support and document writing /editing, working primarily on Heart Failure medical device projects. Clinical writing (using MS Word and Adobe) and data analysis (scientific / clinical data) skills required.
  • The ability to understand / summarize / review / edit clinical information is a priority for the role. Project management skills including the ability to communicate effectively with external vendors, internal writers, and cross-functional SME’s and plan project timelines are desirable.

Some key responsibilities include:

  • Understanding of EU MDR  & MEDDEV 2.7.1/ rev 4 requirements for Clinical Evaluation, Post Market Clinical Follow-up, and Post Market Surveillance
  • Experience working with medical, clinical and technical documentation, document control systems, and Quality Management Systems
  • Supervising the development and maintenance of Clinical Evaluation Plans and Reports and related documents, including reviewing / editing / publishing (via pdf creation) and authoring sections of large documents, specifically Clinical Evaluation Reports (CER), Clinical Evaluation Plans (CEP), Post Market Surveillance Plans (PMS Plan) and Reports, Summary of Safety and Clinical Performance (SSCP), Post Market Clinical Follow-up (PMCF) Plans & Reports
  • Understanding of systematic clinical literature reviews
  • Able to provide guidance on the quality and sufficiency of clinical evidence and justify inclusion / exclusion of clinical data
  • Experience managing large projects, including communication with cross functional SME’s, internal writers, and external consultant teams.
  • Experience tracking status and monitoring projects – assigned tasks, deliverables, writers / external consultants

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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You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition.

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

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