Senior Specialist, Regulatory Artwork

Job Description

The Position

The Artwork Senior Specialist is responsible for the regulatory role as part of the process for coordination, development, and implementation of new and revised artwork for commercial products as well as products in development.

Responsibilities

• Perform labeling assessments and manage external vendors to develop, revise, prepare, and internally approve packaging artworks (e.g., carton, container label, printed package insert).

• Provide functional knowledge at relevant department and cross functional meetings to ensure packaging content and artworks are compliant with internal labeling policies, standard operating procedures, and health authority regulations.

• Point of contact for US/Global artwork stakeholders within and outside of Research and Development (R&D).

• Point of contact with manufacturing business partners, as appropriate.

• Interpret labeling regulations and guidance, identifying company impact and providing recommendations, as appropriate.

• Assess and assist with updating global labeling SOPs to support the end-to-end labeling processes to ensure process optimization.

• Assist in the preparation and presentation of metrics and KPIs such as AIR2 (Implementation on time).

• Support Health Authority (HA) inspection requests as well as internal audit requests.

• Support GL investigations regarding labeling or artwork errors, support Fact Finding meetings and CAPA development, tracking and completion.

• Support global labeling process for device development including metrics tracking.

• Support IT initiatives including Enterprise Digital Initiative, as needed, to ensure labeling compliance and quality needs are met.

Required Education, Experience and Skills

• Bachelor’s degree or relevant work experience. Master’s degree preferred.

• Minimum of five years pharmaceutical/biological experience in a labeling, regulatory, compliance or quality function or relevant professional experience. Proactive motivated individual willing to drive results. Detail oriented, well organized, with ability to manage multiple projects and prioritize work.

• Experience working with teams at all levels, driving consensus and results.

• Excellent leadership, communication, interpersonal and collaboration skills.

• Experience using SharePoint capabilities and related document technology related to Organon labeling execution i.e., APPIAN, RSDM (Veeva), MIDAS, GLAMS, Adobe Creative Cloud, Microsoft Office + Teams, GlobalVision Proofware, etc.

• Experience in labeling operations, artwork development, review, and approval, and manufacturing related processes and knowledge of regulatory systems. Knowledge of Global Regulatory and/or Clinical processes and work types.

• Familiarity with proofreading, electronic proofreading tools, and preparation of SPL updates via a SPL vendor.

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 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.

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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)

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:

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: