Associate Director leading innovation initiatives for LGBTQ+ health at Penn. Overseeing project execution and sustainability strategies to improve health outcomes.
About the role
- Associate Director leading safety analysis at Johnson & Johnson to advance oncology treatments. Collaborating with teams to review and evaluate safety data for innovation.
Responsibilities
- 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
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 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
Benefits
- 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
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