Senior Specialist, Regulated System Business Oversight

This job is with Organon, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ business community. Please do not contact the recruiter directly.

Job Description

The Position

The Regulated Systems Business Oversight (RSBO) Supporting Systems, Senior Specialist is responsible for supporting regulated Organon Research & Development (R&D) systems in alignment with the future vision, strategy and roadmap.

The RSBO Strategy and Execution, Supporting Systems, Senior Specialist reports into an RSBO Strategy and Execution, Director within the RSBO team. This role requires effective collaboration with cross functional teams to deliver 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, have an innovative mindset and ability to drive assignments through to completion.

Performs select business system ownership responsibilities with routine and direct managerial involvement (e.g. SDLC deliverables, UAT execution, change governance, audit support, system training/SOP, data standards quality, metrics, system access).

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

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 company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

US and PR Residents Only

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Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.

Search Firm Representatives Please Read Carefully

Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US)

$93,500.00 - $158,900.00

Annualized Salary Range (Global)

Annualized Salary Range (Canada)

Please Note: Pay ranges are specific to local market and therefore vary from country to country.

Employee Status

Regular

Relocation:

VISA Sponsorship

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

Shift

Flexible Work Arrangements:

Valid Driving License

Hazardous Material(s):

Number Of Openings

2

Requisition ID:R533071