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- Tasks: Lead the regulatory process for artwork development and compliance in a dynamic team.
- Company: Join Organon, a $6.5 billion global healthcare company focused on women's health.
- Benefits: Enjoy flexible work arrangements, health benefits, and a supportive work culture.
- Why this job: Make a real impact in healthcare while collaborating with diverse teams and driving innovation.
- Qualifications: Bachelor’s degree required; five years of relevant experience preferred.
- Other info: Remote work options available; must meet travel and credentialing requirements.
The predicted salary is between 43200 - 72000 £ per year.
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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.
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
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)
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:
No relocation
VISA Sponsorship
No
Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
10%
Flexible Work Arrangements
Remote Work
Shift
Valid Driving License:
Hazardous Material(s)
Number of Openings:
1
Requisition ID: R534829
Seniority level
-
Seniority level
Mid-Senior level
Employment type
-
Employment type
Full-time
Job function
-
Job function
Legal
-
Industries
Pharmaceutical Manufacturing
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Senior Specialist, Regulatory Artwork employer: Organon
Contact Detail:
Organon Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Specialist, Regulatory Artwork
✨Tip Number 1
Familiarise yourself with the specific regulatory requirements and guidelines relevant to artwork in the pharmaceutical industry. Understanding these regulations will not only help you in interviews but also demonstrate your proactive approach to compliance.
✨Tip Number 2
Network with professionals already working in regulatory roles within the pharmaceutical sector. Engaging with them on platforms like LinkedIn can provide valuable insights into the role and may even lead to referrals.
✨Tip Number 3
Showcase your experience with relevant software tools mentioned in the job description, such as Adobe Creative Cloud or GlobalVision Proofware. Being able to discuss your proficiency with these tools can set you apart from other candidates.
✨Tip Number 4
Prepare to discuss specific examples of how you've managed projects or collaborated with cross-functional teams in previous roles. Highlighting your leadership and communication skills will be crucial in demonstrating your fit for this position.
We think you need these skills to ace Senior Specialist, Regulatory Artwork
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, artwork development, and compliance. Use keywords from the job description to demonstrate that you meet the qualifications.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and the company. Mention specific experiences that align with the responsibilities listed in the job description, such as managing external vendors or interpreting labeling regulations.
Highlight Relevant Skills: In your application, emphasise skills that are crucial for the role, such as attention to detail, project management, and familiarity with tools like SharePoint and Adobe Creative Cloud. Provide examples of how you've successfully used these skills in past roles.
Proofread Your Application: Before submitting, thoroughly proofread your CV and cover letter. Look for any spelling or grammatical errors, and ensure that all information is clear and concise. A polished application reflects your professionalism and attention to detail.
How to prepare for a job interview at Organon
✨Know Your Regulations
Familiarise yourself with the latest labelling regulations and guidelines relevant to the pharmaceutical industry. Be prepared to discuss how these regulations impact artwork development and compliance during your interview.
✨Showcase Your Experience
Highlight your previous experience in regulatory roles, particularly in artwork development and approval processes. Use specific examples to demonstrate your ability to manage multiple projects and collaborate with cross-functional teams.
✨Prepare for Technical Questions
Expect technical questions related to labelling assessments and the tools used in the process, such as SharePoint or Adobe Creative Cloud. Brush up on your knowledge of these tools and be ready to explain how you've used them in past roles.
✨Demonstrate Leadership Skills
As a Senior Specialist, you'll need to show strong leadership and communication skills. Prepare to discuss situations where you've driven consensus among stakeholders or led a project to successful completion, showcasing your ability to influence and guide others.
