Associate Director, Regulated System Business Oversight

Job Description

The Position

The Regulated Systems Business Oversight (RSBO) Strategy and Execution Associate Director with a focus on the Regulatory pillar is responsible for leading and supporting regulated Organon Research & Development (R&D) systems in alignment with the future vision, strategy and roadmap.

The RSBO Strategy and Execution, Associate Director reports into the RSBO Strategy and Execution, Director, Regulatory Pillar within the RSBO team. This role requires effective collaboration with cross functional teams to drive key projects and establish relationships with stakeholders to ensure alignment and agreement.

Success in this role depends on a candidate’s ability to develop relationships with cross functional teams, lead complex, cross-functional R&D projects, have an innovative mindset and ability to drive projects through to completion, including communication and change management.

The ideal candidate will come into our NJ or PA office in a hybrid capacity.

Responsibilities

• Work closely with the RSBO Pillar Leads to develop, implement and maintain regulated business systems supporting R&D with a focus on leveraging innovative technologies such as Artificial Intelligence and automation while considering an R&D wide perspective.

• Partner with the R&D Business Technology (BT) teams to manage and maintain a prioritized portfolio of work for R&D’s regulated systems.

• Influences peers and senior leaders to see new opportunities for enhanced digital and information management capabilities within the R&D functions.

• Participate in complex, large-scale, cross-functional, global system implementation initiatives, ensuring appropriate change management and training across the organization.

• Engage with functional stakeholders to gather business requirements and aggressively prioritize incremental enhancements to ensure they add measurable value or reduce cost to R&D.

• Coordinate or execute User Acceptance Testing (UAT) for system implementations and updates ensuring business requirements are tested completely ensuring the business needs are met.

• Develop and maintain strong relationships with key stakeholders and members of the R&D functional areas.

• Drive a culture of inclusivity, respect, innovation and entrepreneurism.

• Stay current with industry trends to support the successful implementation of business priorities.

Required Education, Experience and Skills

• Bachelor’s degree in a business, scientific, or operational discipline relevant to the life sciences and/or operations required with five years of related experience

• Business Acumen: Lead and drive regulated system implementation and upgrade projects.

• Industry knowledge: Experience or knowledge of the end-to-end research and development processes.

• Leadership: Ability to engage and influence senior level stakeholders around business strategy, goals, and business outcomes, and drive them towards strategic decisions. Ability to drive and influence work outside of your function.

• Collaboration: Work with individuals and groups in a constructive and collaborative manner, including the ability to build and maintain critical networks and collaborative relationships.

• Oral and Written Communications: Outstanding verbal, written, and executive level presentation abilities and interpersonal skills.

• Team Leadership: Help build and lead a high-performing team, provide mentorship, guidance and support to drive individual and collective success.

• Performance metrics: Establish and monitor key performance indicators (KPIs) to measure the effectiveness and impact of ongoing system support and maintenance as well as system upgrades and implementations.

• System Validation: Strong understanding of standard components of the SDLC and requirements for supporting regulated systems and approaches to testing and validation.

• Technical expertise: Experience successfully delivering workflow automation technologies such as Appian or Microsoft Power Apps

• Minimum five years delivering regulated systems in the pharmaceutical or biotech industries, preferably in a regulatory affairs, clinical, medical affairs, or pharmacovigilance domain.

• Experience leading projects through to implementation.

Preferred Education

• Master’s degree preferred.

Secondary Language(s) Job Description

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare com