Associate Director, Submission Program Management Lead
Johnson & Johnson
full-time
Posted on:
Location Type: Hybrid
Location: Spring House • New Jersey, Pennsylvania • 🇺🇸 United States
Visit company websiteSalary
💰 $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 for Johnson & Johnson Innovative Medicine (JJIM).
- The SPML will be responsible for leading global, cross-functional submission teams to meet or exceed the operational delivery goals for JJIM’s major submissions in EU and U.S. markets.
- This individual will work across teams at all levels of the organization to ensure the highest probability of successful submission delivery while enhancing team empowerment, effectiveness, and efficiency in accordance with the Johnson & Johnson Credo.
- Close partnership with the CDT, Therapeutic Area (TA), and Functional Leadership, working hand in hand with the GRL to facilitate alignment, clarity, understanding, and endorsement of the overall submission strategy or submission “North Star” based on target label and overall global regulatory strategy.
- Driving development of the end-to-end operational submission strategy in alignment with overall submission strategy and goals, ensuring alignment and commitment from functional leaders and team members.
- Oversight of operations/delivery process, leading the cross-functional submission workgroup(s) and partnering with responsible functional project managers and team members to drive planning, optimization, and execution.
- Close partnership with team and functional leaders to ensure adherence to leading practices, proper risk mitigation and delivery enhancement strategies.
- Maintaining and communicating execution level critical path throughout submission delivery and perform ongoing critical path analysis to continuously drive efforts to uncover and exploit new opportunities to de-risk, accelerate, and increase overall probability of on-time submission delivery.
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
- 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
- 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
- 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, including working with external partners
- Proven experience conducting business process, scenario, and critical path analysis on complex projects with accelerated timelines.
- Demonstrated strong “content awareness” and understanding of interdependencies between all major documents of eCTD.
- Experience leading teams through delivery of clinically focused sections of Module 2, Module 5, and Module 1 label and risk sections.
- Knowledge of global regulations, regulatory timelines, guidelines, and regulatory requirements related to marketing application in the U.S. and EU.
- 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.
- Ability to resolve controversy and influence teams without formal authority.
- Ability to influence decision-making at all levels and represent project teams with senior leadership and governance bodies.
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; for employees who reside in the State of Washington – 56 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
project managementcross-functional team leadershipend-to-end drug developmentcritical path analysiseCTD document awarenessregulatory requirementsmarketing application deliveryplanning and visualization methodsrisk mitigation strategiessubmission strategy development
Soft skills
verbal communicationwritten communicationinnovative thinkingcritical thinkingcross-cultural communicationteam motivationdecision-makinginfluence without authorityorganizational awarenessproblem resolution