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About Innovative Medicine:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https: //www.jnj.com/innovative-medicine

We are searching for the best talent for a Senior Manager, Investigational Product Training & Strategy to be located in Beerse, Belgium or Madrid, Spain.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-015760

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Purpose:

The Clinical Trial Learning & Training (CTL& T) organization develops and implements training strategy and design for clinical trial training and Global Clinical Operations (GCO) functional role-based global onboarding programs. This includes determining training needs, developing, and implementing strategic learning initiatives, and leveraging resources to deploy the training plan. CTLT delivers impactful learning and training programs that address gaps and build capabilities to meet future needs while ensuring compliance with relevant Regulations, Standards, and Good Clinical Practice. The organization aims to enhance the effectiveness of learning for those conducting clinical trial activities, improve site engagement/satisfaction and enhance preparedness of GCO roles that support portfolio services.

The Senior Manager is responsible for deploying training strategy and delivery across clinical trial, specific to investigational product preparation/administration and role-based training programs. This includes oversight of processes, along with leading projects to bring best-in-class training across the globe. The Senior Manager will engage with key stakeholders, vendors, and lead teams/peers responsible for training creation, facilitation, and delivery. This role will partner with team members to lead enhanced site facing interactions and compliance related operations for investigational product preparation and administration in support of portfolio services.

You will be responsible for:
• Provides leadership and direction to internal team to deliver high quality communication and training for investigational product preparation instructions to internal sponsor staff and with investigational sites.
• Understands intended training/scientific roles and competencies to define necessary training strategy and deliver investigational product preparation instructions.
• Collaborates with the Director, GCO Learning & Training to enhance the organizational strategy for effective design, development, deployment, and administration of training programs that support internal business objectives.
• Keeps abreast of training and clinical development research, specifically early development techniques and investigational products, within/out of industry.
• Sets expectations for creative and effective training modalities as the norm for the overall training strategy, in partnership with Learning Strategy.
• Leads departmental initiatives connected to creation, delivery, maintenance, and evaluation of investigational product preparation education.
• Effective leadership skills, ability to develop and implement strategies, and to foster team productivity and cohesiveness is required.
• Support pharmacy/investigational product related inspection readiness activities and provide inputs and follow up on audit CAPAs.
• Monitor key risk indicators, escalate, and mitigate as required.
• Excellent organization skills and the ability to collaborate and handle multiple priorities within a matrix environment is required.
• Evaluates data from various inputs and makes recommendations for changes to strategy.
• Executes the organizational strategy that will support continuous learning, knowledge management, success measurements and continuous improvement.
• Contributes to the definition and development of new processes, standards, or operational plans in support of the organizational/ business strategies, with a direct impact on business unit/function overall results for all areas of focus within CTL& T.

Qualifications / Requirements:

Education:
• Minimum of Bachelor’s degree is required
• Advanced degree in Pharmacy/PharmD is highly preferred

Required:
• Minimum of 8-10 years of previous pharmaceutical, CRO, or investigational site experience and compounding experience in clinical or hospital setting
• Business experience working in education and/or training capacity
• People management and leadership experience
• Oncology experience
• Early Development/First-in-human previous clinical trial experience
• Strong knowledge of drug development, clinical research operations and regulatory requirements, including ICH-GCP, GMP and applicable regulations
• Familiarity with global site practices
• Highly effective personal leadership skills with demonstrated competency interfacing with all levels of the organization including senior leaders
• Experience in R& D process requirements to successfully drive GCO Compliance productivity, strategy optimization, process improvements and efficiencies including optimal development and management of training content, approaches, and delivery
• Excellent communication skills, both oral and written, as well as proven conflict management and negotiation skills
• Proficiency with Microsoft Office tools (e.g., Excel, PowerPoint, One Note), Office 365 and SharePoint (or other similar collaboration tools), and graphical tools that enables to the ability to organize complex ideas visually
• Ability to travel 10-50% of the time, defined by business needs

Preferred:
• Immunology experience