Associate Director, Safety Analysis Scientist

Role Overview

• Lead proactive safety data reviews, if applicable and form a safety position across JJEI which can be leveraged for aggregate safety reports.
• Support SMT activities (e.g. preparing and presenting data, compiling meeting minutes, updating signal tracking information).
• Demonstrate leadership in the SMT and support the SSO.
• Drive safety evaluations including risk-benefit discussions, collaborating with SSO and other stakeholders as necessary, data retrieval, data analysis, report writing, and report revision.
• Provide input and review to key regulatory or clinical documents as appropriate.
• Assume responsibility for novel projects, create value and innovate without defined processes.
• May seek guidance from senior leadership (i.e SSO, Chief Safety Officer (CSO) for complex projects.
• Lead cross-functional training of relevant stakeholders.
• Act as safety database querying Subject Matter Expert (SME) for audits/inspections.
• Participate in, or lead, department and/or cross-functional initiatives.
• Explore innovative ways of presenting data, preparing reports, and improving efficiencies within the programs they own.
• Assist SSO and operational leads in the creation, review and implementation of controlled documents and other related tools.
• Management of unscheduled reports within the Aggregate Report Calendar.
• Liaison activities within pharmaceutical and medical technology sectors, as applicable.
• Line-management of contractor positions within the team, as applicable.
• Oversight of deliverables by other team members (e.g. complex reports), as needed.

Requirements

• Bachelor's degree in a healthcare or biomedical science discipline and 11+ years of industry experience required.
• Master's degree in a healthcare or biomedical science discipline and 8+ years of experience or a PharmD/PhD in a healthcare or biomedical science discipline and 5+ years experience preferred.
• Medical writing or PV experience required.
• Clinical experience preferred.
• Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements required.
• Ability to understand and analyze complex medical-scientific data from a broad range of disciplines required.
• Ability to interpret and present complex data to determine benefit-risk impact required.
• Excellent English verbal and written communication skills required.
• Ability to effectively interact with stakeholders, including business partners required.
• Ability to work in a matrix environment, proven leadership skills required.
• Ability to plan work to meet deadlines and effectively handle multiple priorities required.
• Proficiency in Microsoft applications (e.g. Word, Excel, and PowerPoint) required.
• Ability to independently influence, negotiate and communicate with both internal and external customers required.

Benefits

• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k))
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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