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Job Description

The Position

The Senior Specialist, US Promotions Standards, Quality & Label Operations is responsible for developing, implementing, and facilitating quality management solutions related to the promotional resource development lifecycle, inclusive of foreign language translation work. This individual will also perform key activities around the development and execution of processes, procedures, and oversight for the Product Label (Safety/Non-Safety Label Updates) associated with Marketing and Promotional material within the US Market.

The Specialist will conduct evaluations of the promotion development process to ensure they operate efficiently & effectively, are compliant, & deliver high quality promotional resources. Working closely with functional area leaders & members of promotion review teams, marketing operation & marketing to gather input to understand issues, determine root cause, and develop appropriate corrective action, in accordance with corporate & divisional policies & standards.

The successful candidate will bring experience in effective cross-functional collaboration, root cause analysis, process design and execution. The ideal candidate will have demonstrated success dealing in a fast-paced environment, managing through ambiguity, and adapting to change.

Responsibilities

Problem-Solving and Issue Resolution

+ Proactively identifies issues/risks and works quickly to implement solutions. Facilitates fast, disciplined decision-making.

+ Lead cross functional investigations into US Promotion execution issues with both internal and external impact, determining root cause, and identifying appropriate Corrective and Preventative Actions (CAPA).

+ Collect, analyze, and summarize investigation findings and trends, by presenting to senior leadership within the Office of Promotion Advertising Review (OPAR), Ethics and Compliance, Regulatory Legal, Promotion and Marketing.

+ Maintain and improve quality of review and release of promotional materials by conducting routine audits, leading investigations, prioritizing issues, as well as collaborating with colleagues to establish new standards and training opportunities across internal and external stakeholders.

+ Strategic partnership with technology and business process teams to drive roadmap for platform and operational tools, while representing key business priorities.

Process Design and Execution

+ Facilitate the Safety Label Change Communication Plan Implementation Committee (CPIC) upon receiving a notification of label change.

+ Provide oversight for the execution for safety label changes for the US Market to ensure timelines are met.

+ Work with a cross-functional team to develop and maintain all safety related communication tactics.

+ Subject Matter Expert to provide consultation to US Marketing and Promotion.

+ Maintain procedures for creating and updating all US Promotion Process Standard and Guidance Documents.

+ Oversee and support the communication of processes to all relevant user groups for all US Promotion Process Standards and Guidance Documents.

+ Facilitate the Promotional Assessment and Asset Retirement Process for label updates and Reapproval process.

Required Education, Experience and Skills

+ BS, BA degree.

+ Experience in the Pharmaceutical industry, or, other highly regulated environment.

+ Experience working in a fast-paced, cross-functional team environment.

+ Excellent communication skills through a variety of channels (email, in-person, phone and MS Teams).

+ Ability to influence without authority (ability to manage up).

+ Ability to work both independently and collaborate with team members both in person and via collaboration tools.

+ Exceptional attention to detail.

+ Ability to take complex processes/SOPs and simplify for end user through promotional guidance communications and training.

+ Demonstrated ability to learn quickly.

+ Excellent problem-solving skills.

+ Superior project management skills, ability to prioritize work, and work successfully in a deadline driven environment.

Preferred Experience and Skills

+ Experience in Quality, Pharmaceutical Promotions and/or Marketing Operations related field.

+ Knowledge of the Promotion Review Team process within the pharmaceutical industry.

+ Experience with Veeva Vault PromoMats.

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

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted 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

Please Note: Pay Ranges are Specific to local market and therefore vary from country to country

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

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

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

**Requisition ID:** R536662