Lead cross - functional submission teams in the delivery of major marketing submissions for innovative medicines. Collaborate with regulatory and project management teams to ensure operational success and quality.
About the role
- Associate Director leading submission program management for Johnson & Johnson Innovative Medicine. Ensuring end-to-end operational delivery of major marketing submissions in U.S. and EU markets across global teams.
Responsibilities
- The Submission Program Management Leader (SPML) will be accountable for the end-to-end operational delivery of major marketing submissions
- The SPML will be responsible for leading global, cross-functional submission teams
- Driving development of the end-to-end operational submission strategy in alignment with overall submission strategy and goals
- Oversight of operations/delivery process, leading the cross-functional submission workgroup(s)
- Ensuring adherence to leading practices, proper risk mitigation and delivery enhancement strategies
- Engaging business and team leaders in advance of full deployment of the Submission Delivery Framework
- Leading planning and execution of the Submission Kick-off meeting
- Ensuring team alignment to overall key messaging and data pooling/incorporation strategies
- Leading translation of submission strategy and scope into integrated submission plan (ISP)
- Owning detailed planning and execution oversight for Module 2 components and critical path Module 1 components
- Maintaining and communicating execution level critical path throughout submission delivery
- Leading ongoing risk management efforts including identification and quantification of risks
- Promoting high-performing, people-centric team culture, empowering teams to drive rapid and informed decision making
Requirements
- A minimum of a Bachelor's degree is required, preferably in Life Sciences, Business Management, Regulatory Affairs or a related field
- 8+ years of industry/business experience is required
- A minimum of 5 years of experience leading cross-functional teams in a matrixed work environment is required
- 3+ years of experience in a Pharmaceutical, MedTech or comparable R&D area with demonstrated organizational awareness and applied knowledge of end-to-end (E2E) drug or medical device development is required
- A minimum of 3 years of formal project management experience with high proficiency and demonstrated application of project management standards, planning and visualization methods/tools is required
- Demonstrated project management leadership of cross-functional submission teams through delivery of major marketing applications in U.S. and/or EU in a matrixed setting is required
- Proven experience conducting business process, scenario, and critical path analysis on complex projects with accelerated timelines is required
- Demonstrated strong “content awareness” and understanding of interdependencies between all major documents of eCTD is required
- Experience leading teams through delivery of clinically focused sections of Module 2, Module 5, and Module 1 label and risk sections is required
- Knowledge of global regulations, regulatory timelines, guidelines, and regulatory requirements related to marketing application in the U.S. and EU is required
- Must have excellent verbal and written communication skills
- Must have strong innovative and critical thinking skills
- Must have effective cross-cultural communication skills with the ability to motivate and inspire a team to action
- Ability to drive and expedite team decision-making and translate strategy to clear, executable action plans is required
- Ability to resolve controversy and influence teams without formal authority is required
- Ability to influence decision-making at all levels and represent project teams with senior leadership and governance bodies is required
- Project management certification preferred
- Regulatory certification (RAC) preferred
- Proficiency with Microsoft Project is highly preferred.
Benefits
- medical, dental, vision
- life insurance
- short- and long-term disability
- business accident insurance
- group legal insurance
- retirement plan (pension)
- savings plan (401(k))
- vacation – 120 hours per calendar year
- sick time - 40 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
- condolence leave – 30 days for an immediate family member: 5 days for an extended family member
- caregiver leave – 10 days
- volunteer leave – 4 days
- military spouse time-off – 80 hours
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