Medical Affairs Director

Posting Date 3 weeks ago(9/8/2020 1:04 PM)
Requisition ID
2020-7834
Job Location(s)
Bloomington IN United States
Position Type
Full Time
Company
Cook Medical Holdings
Category
Clinical

Overview

The Medical Affairs Director at Cook Medical provides global guidance and strategic oversight regarding the Medical Affairs team and collaborates across Cook business functions and business units, applying their clinical knowledge and expertise to support device risk assessment, regulatory submissions, product development, internal and external training, global reimbursement efforts, market research, and sales and marketing efforts.

Responsibilities

• Build and maintain working knowledge of Cook's medical devices and the procedures in which they are used. Possess a clinical understanding of the risks, benefits, patient selection and treatment options
• Build and maintain knowledge of the major regulatory and quality systems and international standards, particularly as they relate to risk assessment, benefit-risk determinations, defining the state-of-the-art, and investigation and reporting of complaints
• Establish priorities in collaboration with Cook manufacturing entities, divisions and functions within the Medical Affairs function

• Set goals and expectations for the function; establish capacity, resources, and functional structure needed to meet the goals and expectations; and monitor the function's performance
• Be involved in the recruitment, training, mentoring and performance evaluation (including wage review) of Medical Affairs team members

• Provide oversight and guidance on personnel matters including employee performance issues, corrective action processes, and employee development plans and actions
• Provide clinical experience and support to Regulatory Affairs, the Reimbursement function, Business Development, Product Research and Development, Marketing, Quality Assurance, Engineering and others
• Assist in designing and executing strategies to assure that Cook Medical technologies are well-accepted by healthcare policy makers, HTA bodies, healthcare reimbursement systems, and healthcare providers worldwide
• As needed, assist the team with drafting/reviewing/approving documents such as Hazard Analyses, Benefit-Risk Analyses, Clinical Evaluation Reports, Health Hazard Evaluations, Quality Engineering Risk Assessments, PMCF plans, IFUs, Clinical Effects Analyses, responses to medical bodies, field safety notices, and marketing materials

Qualifications

• MD or DO; residency training/practice experience not required but preferred with a medical device, biotech or pharma companies
• Minimum 5 years experience in Medical Affairs or related field
• Capable technical writing skills

• Strong analytical skills
• Interest and skilled at clinical literature- and web-based research
• Microsoft Office proficiency (Excel, Word, Outlook)
• Proficient in reading, writing and speaking the English language

 

Physical Requirements:

• Works under general office environmental conditions
• Sitting for extended periods, utilizes close visual acuity for working with computers, etc.
• Ability to travel (domestic and international) required
• Requires occasional early morning or late evening teleconferences

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