Associate Director managing pitch competitions at Venture Lab, University of Pennsylvania. Leading startup challenges and facilitating entrepreneurship opportunities for students.
About the role
- Associate Director responsible for safety assessment and analysis of healthcare products at Johnson & Johnson. Leading evaluations to ensure regulatory compliance in innovative medicine.
Responsibilities
- Lead safety evaluations including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other stakeholders as necessary, data retrieval, data analysis, report writing, and report revision.
- Ensure high quality safety evaluations and reports with minimal comments from stakeholders and minimal revisions required.
- Provide input and review of key regulatory or clinical documents as appropriate.
- Demonstrate leadership in the SMT and support the MSO.
- Support SMT activities (e.g., preparing and presenting data, compiling meeting minutes, updating signal tracking information).
- Lead proactive safety data reviews, if applicable and form a safety position across Global Medical Safety (GMS) which can be leveraged for aggregate safety reports.
- Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.
- Assume responsibility for novel projects, create value and innovate without defined processes.
- May seek guidance from Directors (i.e., SAS TAL) for complex projects.
- Lead cross-functional training of relevant stakeholders.
- Act as product or process 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 Directors in the creation, review and implementation of controlled documents and other related tools.
- Management of unscheduled reports within the Aggregate Report Calendar.
- Management activities within smaller Therapeutic Areas, as applicable.
- Line-management of contractor positions within the team, as applicable.
- Act as backup to TAL as needed (e.g., Director SAS TAL is unavailable).
- Oversight of deliverables by other team members (e.g., complex reports), as needed.
Requirements
- Bachelor’s Degree Required: Healthcare-related or Biomedical Science (11+ years industry experience or equivalent).
- Advanced Degree Preferred: Healthcare-related or Biomedical Science (8+ years industry experience or equivalent).
- Medical writing or Pharmacovigilance (PV) experience required.
- Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements.
- Ability to understand and analyze complex medical-scientific data from a broad range of disciplines.
- Ability to interpret and present complex data to determine benefit-risk impact.
- Excellent English verbal and written communication skills.
- Ability to effectively interact with stakeholders, including business partners.
- Ability to work in a matrix environment, proven leadership skills.
- Ability to plan work to meet deadlines and effectively handle multiple priorities.
- Proficiency in Microsoft applications (e.g., Word, Excel, and PowerPoint).
- Ability to independently influence, negotiate and communicate with both internal and external customers.
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))
- Vacation – up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
- Holiday pay, including Floating Holidays – up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
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