Manager, Scientific Operations

Role Overview

• Provides strategic oversight and guidance to all SciOps resources on compliant document execution and generation
• Manages relationships and contracting with external vendors for generation of documents supporting these processes
• Develops strategic plans to ensure deliverable timelines are met, and practices are being consistently deployed across the organization
• In conjunction with the Director and, if applicable, Sr. Manager, designs, develops and leads workshops to define processes and keeps abreast of regulatory requirements and industry trends / practices, ensuring that a proactive ongoing review of processes and procedures is in place to maintain a strong regulatory profile while continually improving process efficiencies
• Develops and monitors metrics for all deliverables within his/her therapeutic space, providing visibility of issues and enable corrective and preventive action to be taken as needed
• Accountable for assisting in the development and management of the Scientific Operations budget
• Supports interactions with respective Notified Bodies and regulatory agencies
• Supports audits and inspections pertaining to SciOps processes and deliverables
• Actively partners with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable
• For those who supervise or manage a staff, responsible for ensuring 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
• Performs other duties assigned as needed

Requirements

• BA, BS, or BSN is required; advanced degree is preferred
• Minimum of 5 years of related job experience
• Experience with Spine Therapeutic area preferred
• Experience within the medical device industry and knowledge of Clinical Evaluation Report regulatory requirements, evidence generation, literature reviews, and/or Clinical Evaluation Report (CER) document creation is required
• Demonstrated knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting is preferred
• Able to understand and interpret statistical results of clinical studies and understands good data management practices
• Strong oral communication, presentation, project management and prioritization skills
• Excellent interpersonal relationships
• 10% Domestic and International Travel required

Benefits

• Vacation –120 hours per calendar year
• Sick time
• 40 hours per calendar year; for employees who reside in the State of Colorado –48 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
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year