Overview
Join to apply for the Associate Director, Submission Program Management Lead role at Johnson & Johnson Innovative Medicine .
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, profoundly impacting health for humanity. Learn more at https://www.jnj.com.
Locations: Beerse, Antwerp, Belgium; Leiden, South Holland, Netherlands; Allschwil, Switzerland; High Wycombe, United Kingdom.
Responsibilities
Close partnership with the Compound Development Team (CDT), Therapeutic Area (TA), and Functional Leadership to facilitate alignment and endorsement of the overall submission strategy.
Drive development of the end‐to‐end operational submission strategy in alignment with overall goals, ensuring commitment from functional leaders and team members.
Oversee operations/delivery process, lead cross‐functional submission workgroups, and partner with responsible functional project managers to drive planning, optimization, and execution.
Engage business and team leaders in advance of full deployment of the Submission Delivery Framework to confirm availability and alignment of robust source documentation.
Collaborate with the Global Regulatory Leader (GRL) to develop and align on submission strategy and scope.
Lead planning and execution of the Submission Kick‐off meeting with key partners and core team members.
Lead the cross‐functional Submission Working Group (SWG), driving day‐to‐day operational decision‐making and ensuring clarity, commitment, and accountability to the aligned submission strategy.
Maintain and communicate the execution‐level critical path throughout submission delivery and perform ongoing critical‐path analysis to continuously drive efforts to de‐risk, accelerate, and increase the probability of on‐time submission delivery.
Lead ongoing risk‐management efforts: identify, quantify, and transparently communicate risk/uncertainty; develop robust mitigation plans; conduct scenario analysis and contingency planning; and communicate mitigation strategies to CDT and senior leadership.
Promote a high‐performing, people‐centric team culture, empowering teams to drive rapid and informed decision‐making, challenge the status quo, and foster impactful innovation.
Provide robust, customized, and transparent communications throughout the submission process to various audiences.
Qualifications – Education
A minimum of a Bachelor's degree is required, preferably in Life Sciences, Business Management, Regulatory Affairs, or a related field. An advanced degree is preferred.
Qualifications – Required Experience and Skills
8+ years of industry/business experience.
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 knowledge of end‐to‐end (E2E) drug or medical device development.
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.
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.
Excellent verbal and written communication skills.
Strong innovative and critical thinking skills.
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 into 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.
Qualifications – Preferred
Project management certification.
Regulatory certification (RAC).
Proficiency with Microsoft Project.
Travel
Up to 10% travel – Domestic & International.
Employment Type
Full‐time.
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