Lead proactive safety data reviews 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 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

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 of 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

Retirement plan (pension) and savings plan (401(k))
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year; 48 hours for Colorado residents; 56 hours for Washington residents
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 immediate family; 40 hours for extended family 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

Associate Director – Safety Analysis Scientist

Key skills