Clinical Affairs Scientist (Research, Project Manager) in Cary, IL at Stryker Corporation

发布日期: 12/4/2019



Who we want

  • Self-directed imitators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
  • Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
  • Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
  • Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.
  • Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

What you will do

The Staff Clinical Affairs Scientist will be a key member of the Clinical Research team supporting Stryker's Sage division in Cary, IL. This team member will be responsible for:

  • Developing clinical evidence through execution of clinical research studies and authoring of clinical evaluation reports
  • Developing and executing clinical research study plans and clinical evaluation reports including management of schedule, cost, resources, and deliverables (e.g. protocol, contract, budget, milestones)
  • Developing and maintaining collaborative and positive relationships with divisional cross-functional teams and act as Stryker liaison with site investigators, study coordinators, vendors, and other external parties
  • Managing vendors supporting clinical research studies and clinical evaluation reports
  • Participating as a member of Research & Development (R&D)/New Product Development (NPD) teams to maintain ongoing relationships and develop a strategy to generate clinical evidence to support products, including claims development and publication plans
  • Leading cross-functional team members toward timely completion of project deliverables
  • Proactively identify and manage risks that could derail projects (e.g., regulations, new product launch timelines, etc.)
  • Review and approve all collateral material; Contribute to departmental initiatives
  • Maintain current knowledge in area of expertise through attendance at conferences, professional association meetings, and review and analysis of published literature
  • Actively participate in the ongoing development of a corporate culture that strives to achieve the highest ethical standards; conduct all business affairs ethically and lawfully and by ensuring open, honest communication without fear of retaliation

What you need

  • Bachelor’s degree in Nursing, Biomedical Engineering, Science or related field
  • 5+ years relevant experience in the medical and/or pharmaceutical industry
  • 2+ years experience in clinical research of pharmaceuticals or medical devices
  • 2+ years experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting
  • Experience with IND and IDE
  • Excellent writing and analytical skills, including statistical analysis
  • Must be able to interpret medical and research terminology, work with minimal supervision and collaboratively
  • Must be highly customer service oriented

You may also have

  • Masters in Nursing, Biomedical Engineering, Science or related
  • Experience with pharmaceutical clinical trials
  • Knowledge in pharmaceutical regulations, medical device regulations, regulatory affairs, and compliance

Work From Home: No

Travel Percentage: Up to 25%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.