Manager, Medical Affairs Lifecycle Management

Job Description:

• Provide Lifecycle Management for marketed products including labelling updates, medical support and accountability for technical files and documents and medical support to Quality groups
• Support literature review, analysis, and conclusions for Clinical Evaluation Reports (CERs) and related documents (i.e.: SOA; CEP; Literature Review, SSCP, PMCF) and provide final review of CERs and related documents
• Research, prepare and document responses to Medical Information Requests from Healthcare providers
• Review and approve medical content in Copy Approval process; consult with Clinical Medical Directors when needed
• Collaborate closely with the Clinical Medical Directors in support of business responsibilities
• Contribute to value dossiers for marketed products
• Assess work volumes, effectively prioritize business needs to meet the demand, and escalate workload constraints according to leadership strategy
• Act as a team member supporting and collaborating with the other LCM managers
• Responsible for communicating business related issues or opportunities to next management level
• For those who supervise or manage others, ensure that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Perform other duties assigned as needed, including internal process, insight management, and business development, and evidence generation support
• Guide junior colleagues through consultation and mentoring in techniques and processes, and provides functional (matrix) supervision

Requirements:

• Relevant health-related degree (MD, DO, DPM, PhD, RN, PA-C, etc.) required
• Minimum of 5 years of experience in clinical patient care (preferably Orthopaedics)
• 5 years of relevant experience in pharmaceutical or medical device lifecycle management is required
• Knowledge of Orthopaedics conditions and devices used in the diagnosis and management of Orthopaedics conditions, including knowledge of medical alternatives, treatment standards and technology is required
• Knowledge of clinical trial design, evidence generation, adverse event reporting, surgical practices/principles is required
• Demonstrated knowledge and experience in quality compliance, regulatory compliance, and healthcare compliance is required
• Operating room experience is preferred
• People management experience is preferred
• Verbal and written communication skills, problem solving, critical reading skills, knowledge of medical and anatomical terminology
• Proficiency with standard office suites such as Outlook, Word, Excel and similar applications

Benefits:

• medical
• dental
• vision
• life insurance
• short- and long-term disability
• business accident insurance
• group legal insurance
• consolidated retirement plan (pension)
• savings plan (401(k))
• long-term incentive program
• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member
• Caregiver Leave – 10 days
• Volunteer Leave – 4 days
• Military Spouse Time-Off – 80 hours

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