Associate Director, Submission Program Management Lead
OneTrust
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
- accountable for the end-to-end operational delivery of major marketing submissions for Johnson & Johnson Innovative Medicine (JJIM).
- 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.
- primary interface to JJIM’s Compound Development Team (CDT) regarding operational submission strategy.
- 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.
- 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).
- driving planning, optimization, and execution.
- ensuring adherence to leading practices, proper risk mitigation, and delivery enhancement strategies to provide the team with the highest probability of operational success in submission delivery.
- engaging business and team leaders in advance of full deployment of the Submission Delivery Framework.
- collaborating with CDT and functional leaders to develop and align on submission strategy and scope.
- leading planning and execution of the Submission Kick-off meeting.
- leading cross-functional Submission Working Group (SWG).
- ensuring team alignment to overall key messaging and data pooling/incorporation strategies.
- facilitating strategic discussions in collaboration with key partners and Senior Leadership.
- owning detailed planning and execution oversight for Module 2 components.
- maintaining and communicating execution level critical path throughout submission delivery.
- leading ongoing risk management efforts.
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.
- 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
- consolidated 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 managementcritical path analysisbusiness process analysiseCTDend-to-end drug developmentclinical section deliveryregulatory requirementsrisk managementplanning and visualization methodssubmission strategy
Soft skills
verbal communicationwritten communicationinnovative thinkingcritical thinkingcross-cultural communicationteam motivationdecision-makinginfluence without authoritystrategic planningteam alignment
Certifications
project management certificationregulatory certification (RAC)