Associate Director, Submission Program Management Lead

Role Overview

• 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 in accordance with the Johnson & Johnson Credo
• engage business and team leaders in advance of full deployment of the Submission Delivery Framework
• in partnership with the GRL, collaborate with CDT and functional leaders to develop and align on submission strategy and scope
• lead planning and execution of the Submission Kick-off meeting
• lead cross-functional Submission Working Group (SWG), driving day-to-day operational decision-making
• maintain and communicate execution level critical path throughout 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 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, including working with external partners, 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

Benefits

• inclusive work environment
• health is everything