Hybrid Associate Director, Submission Program Management Lead

at Johnson & Johnson

• Job title: Associate Director, Submission Program Management Lead
• Job type: Full Time
• Experience level: Senior
• Salary: $137,000 - $235,750 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Raritan, United States

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