Johnson & Johnson

Associate Director, Submission Program Management Lead

Johnson & Johnson

full-time

Posted on:

Location Type: Hybrid

Location: Raritan • New Jersey • Pennsylvania • United States

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Salary

💰 $137,000 - $235,750 per year

Job Level

Senior

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
project managementcross-functional team leadershiprisk managementcritical path analysisend-to-end drug developmenteCTD content awarenessModule 2 componentsModule 5 componentsModule 1 labelbusiness process analysis
Soft Skills
verbal communicationwritten communicationinnovative thinkingcritical thinkingcross-cultural communicationteam motivationdecision-makinginfluence without authoritystrategic translationconflict resolution
Certifications
project management certificationregulatory certification (RAC)