Job Title: Associate Director, Clinical Evaluations
Location: Remote, U.S.
Summary of Position:
Alcon is looking to hire Associate Directors of Clinical Evaluations within their Medical Writing Department. As an Associate Director of Clinical Evaluations, one will manage a team of Clinical Evaluation Specialists contributing to the conduct of Clinical Evaluations for Life-Cycle Management (ie, Development through Post Market support, to device end of life) and the provision of technical documentation. This individual will collaborate with Clinical Evaluation management and other functions in Clinical Research and Development to ensure the timely production of compliant clinical evaluations and high quality supporting documents.
Key Responsibilities:
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Oversee and manage each of the clinical evaluation projects for the Group.
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Ensure high quality and timely delivery of tasks/projects assigned to Group.
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Responsible for project information flow (resources, status of assigned activities, issues) to teams and to Director, Clinical Evaluations.
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Interact with other Group and Function Heads to ensure proper prioritization of programs and assign adequate resources according to agreed strategy and timelines.
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Identify issues and resource gaps for the preparation and delivery of the different documents; ensure resolution of issues including anticipation; negotiate and implement solutions in collaboration with other Clinical Evaluation Group and Function Heads.
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Ensure adherence to internal policies and processes and to regulatory requirements.
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Ensure effective development and implementation of training and development plans as needed.
Key Requirements/Minimum Qualifications:
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Bachelor’s Degree or Equivalent years of directly related experience (or high school+15 yrs;Assoc.+11 yrs; M.S.+4 yrs; PhD+3 yrs)
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The ability to fluently read, write, understand and communicate in English
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7 Years of Relevant Experience
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Knowledge of MEDEV 2.7/1 Rev. 4, Medical Device Regulation 2017/745
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Work hours: Full Time
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Travel Requirements: 5%; to include international and domestic
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Relocation assistance: NO
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Sponsorship available: NO
Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to alcon.recruitment@alcon.com and let us know the nature of your request and your contact information.
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