Directeur d'expérience en certification at Demers Beaulne overseeing audit strategies and managing team performance in a hybrid setting with professional development opportunities.
About the role
- Lead cross-functional submission teams in the delivery of major marketing submissions for innovative medicines. Collaborate with regulatory and project management teams to ensure operational success and quality.
Responsibilities
- 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.
- 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.
- 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.
- Leading planning and execution of the Submission Kick-off meeting partnering with key partners and core team members.
- Leading cross-functional Submission Working Group (SWG), driving day-to-day operational decision-making and ensuring clarity, commitment, and accountability of team to aligned submission strategy throughout execution at all levels of the submission team and TA Leadership.
- Communicating mitigation strategies and escalation of overall submission-related risks to CDT and Senior Leadership, as required.
- Promoting high-performing, people-centric team culture, empowering teams to drive rapid and informed decision making, challenge status quo, and foster impactful innovation.
- Providing robust, customized, and transparent communications throughout the submission process to various audiences: Ensuring ongoing insight to progress, priorities, and submission “health” according to ISP and defined submission goals.
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.
- 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
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