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Labeling Specialist

3 months ago

Bridgewater, United States Ortho Dermatologics Full time

Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. Each day, Bausch Health products are used by over 150 million people around the world.

Our approximately 7,000 employees are united around our mission of improving people’s lives with our health care products.

**OBJECTIVES/PURPOSE OF JOB** The Proofreader/SPL Specialist, Labeling is responsible to support US Regulatory Affairs Labeling Leads with labeling activities related to development and revisions and labeling compliance activities in accordance with regulations and company process.

**KEY ACTIVITIES/RESPONSIBILITIES** Provide Regulatory support in the development, revision, review, and approval of labeling content for submission to FDA, as well as any post marketing labeling changes.
- Assist Labeling Leads with proofreading of artwork for new and revised Rx and generic drug labeling in accordance with current FDA guidances and regulations.
- Prepare and submit product drug listings and SPL (Structured Product Labeling) files to the FDA’s ESG (Electronic Submissions Gateway) via i4i or CDER Direct
- Prepare and submits Drug Establishment registrations for Bausch Health manufacturing sites.
- Prepares Blanket No-Change Certification for FDA submission for all currently listed drug products.
- Prepare Summary of Labeling Changes section of Annual Report.
- Support Regulatory Labeling team with other labeling activities as needed.

**QUALIFICATIONS/TRAINING/TECHNICAL COMPETENCIES**:

- Strong technology skills and abilities, especially with Microsoft Office programs and web-based programs.
- Ability to critically and efficiently review detailed information to support a labeling revision.
- Knowledge and experience of drug listing and SPL.

**PROFESSIONAL COMPETENCIES**:

- Demonstrated ability in analytical reasoning and critical thinking skills.
- Strong communication skills; both oral and written.
- Strong interpersonal skills with the ability to influence others in a positive and effective manner.
- Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies - able to do so quickly without sacrificing attention to detail.

**EXPERIENCE**:

- Minimum 3 - 5 years relevant pharmaceutical industry and regulatory experience required
- Bachelor’s degree or higher required
- Applied knowledge of FDA labeling requirements perferred
- Familiarity with XML concepts including structured product labels (SPLs) preferred.

As required by law, Bausch Health provides a reasonable range of compensation for roles that may be hired in the US. Actual compensation is influenced by many factors including skill set, level of experience, and specific office location. For this role, the range of starting pay for this role is $55k - $75k.

Benefits package includes a Comprehensive Medical (includes Prescription Drug), Dental, Vision, Health Savings Account with company contribution, Flexible Spending Accounts, 401(k) matching, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term disability, long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, Employee Assistance Plan, commuter benefit, recognition awards, voluntary benefits (including Identity Theft, Student Loan and Breast Milk Shipping), employee referral bonuses and employee discounts.

\#LI-hybrid

**This position may be available in the following location(s)**:location_obj**

Any exception will have to be authorized by your HR Business Partner.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment regardless of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

Bausch Health is an EEO/AA employer M/F/D/V.