Bausch + Lomb
Manager, Pharmaceutical Marketing Operations
Bausch + Lomb, Pierre, South Dakota, United States, 57501
Manager, Pharmaceutical Marketing Operations
Bausch + Lomb is a leading global eye health company dedicated to protecting and enhancing sight for millions of people worldwide. Our mission is simple: helping you see better, to live better. Responsibilities
Lead and facilitate the PRC process, ensuring compliance with SOP throughout the material lifecycle. Work with Project Owners and Managers to collect and prioritize materials for PRC review within the Electronic Review System (ERS). Ensure document readiness, select appropriate ERS workflow and reviewers, prepare agendas, and assess the complexity of PRC comments to determine discussion or removal from the meeting agenda. Chair all PRC meetings (weekly & off‑cycle) as well as claims and concept reviews, ensuring productive discussion and accurate documentation of decisions. Annotate PRC comments during meetings, distribute dispositions, follow up as appropriate, and ensure all required approvers have signed off on materials. Partner closely with commercial teams (Marketing, Sales Training, Market Access, Conventions) to execute business strategies and deliver against timelines. Partner with the PRC process reviewers (Legal, Medical, and Regulatory) to maintain compliance while moving materials efficiently through the process. Manage the ERS functionality, including workflow configuration, reporting capabilities, document retention, Code of Federal Regulations‑compliant e‑signatures, and automated stakeholder notifications. Maintain labeling information relevant to automated FDA Form 2253 generation within the ERS. Effectively prioritize during high volume periods (e.g., product launches, sales meetings). Activate the Editor function in Veeva Vault when a job is given a disposition of Approved With Changes (AWC). Verify that all Legal, Medical, and Regulatory Ad Promo comments and changes have been implemented accurately into promotional materials by Project Managers or agencies. Conduct thorough reviews of revised materials to ensure alignment with approved PRC comments and the final disposition prior to re‑submission or release. Partner with Project Managers and agencies to ensure all changes meet compliance and quality expectations before materials are finalized. Qualifications
Bachelor’s Degree required or equivalent relevant experience in lieu of degree. Minimum of 5 years work experience required; pharmaceutical or medical device industry preferred. Previous PRC lead experience required with demonstrated understanding of Ad Promo review and compliance process. Working knowledge of Veeva Vault and experience managing workflows in an Electronic Review System (ERS) preferred. Understanding of the 2253 submission process and regulatory requirements desired. Strong organizational, communication, and stakeholder management skills; ability to prioritize and balance multiple projects in a fast‑paced environment. Remote‑based position requiring 25% travel, including some overnight travel (e.g., National Sales Meetings). Comprehensive Benefits
Medical, Dental, and Vision Coverage Flexible Spending Account (FSA) Life Insurance 401(k) Savings Plan Employee Stock Purchase Plan Employee Assistance Plan (EAP) Parental Leave Program Free Bausch + Lomb Contact Lenses Group Legal Services Education Assistance Program Adoption Benefits All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status. For U.S. locations that require disclosure of compensation, the starting pay for this role is between $110,000.00 and $130,000.00. U.S. based employees may be eligible for short‑term and/or long‑term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well‑being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
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Bausch + Lomb is a leading global eye health company dedicated to protecting and enhancing sight for millions of people worldwide. Our mission is simple: helping you see better, to live better. Responsibilities
Lead and facilitate the PRC process, ensuring compliance with SOP throughout the material lifecycle. Work with Project Owners and Managers to collect and prioritize materials for PRC review within the Electronic Review System (ERS). Ensure document readiness, select appropriate ERS workflow and reviewers, prepare agendas, and assess the complexity of PRC comments to determine discussion or removal from the meeting agenda. Chair all PRC meetings (weekly & off‑cycle) as well as claims and concept reviews, ensuring productive discussion and accurate documentation of decisions. Annotate PRC comments during meetings, distribute dispositions, follow up as appropriate, and ensure all required approvers have signed off on materials. Partner closely with commercial teams (Marketing, Sales Training, Market Access, Conventions) to execute business strategies and deliver against timelines. Partner with the PRC process reviewers (Legal, Medical, and Regulatory) to maintain compliance while moving materials efficiently through the process. Manage the ERS functionality, including workflow configuration, reporting capabilities, document retention, Code of Federal Regulations‑compliant e‑signatures, and automated stakeholder notifications. Maintain labeling information relevant to automated FDA Form 2253 generation within the ERS. Effectively prioritize during high volume periods (e.g., product launches, sales meetings). Activate the Editor function in Veeva Vault when a job is given a disposition of Approved With Changes (AWC). Verify that all Legal, Medical, and Regulatory Ad Promo comments and changes have been implemented accurately into promotional materials by Project Managers or agencies. Conduct thorough reviews of revised materials to ensure alignment with approved PRC comments and the final disposition prior to re‑submission or release. Partner with Project Managers and agencies to ensure all changes meet compliance and quality expectations before materials are finalized. Qualifications
Bachelor’s Degree required or equivalent relevant experience in lieu of degree. Minimum of 5 years work experience required; pharmaceutical or medical device industry preferred. Previous PRC lead experience required with demonstrated understanding of Ad Promo review and compliance process. Working knowledge of Veeva Vault and experience managing workflows in an Electronic Review System (ERS) preferred. Understanding of the 2253 submission process and regulatory requirements desired. Strong organizational, communication, and stakeholder management skills; ability to prioritize and balance multiple projects in a fast‑paced environment. Remote‑based position requiring 25% travel, including some overnight travel (e.g., National Sales Meetings). Comprehensive Benefits
Medical, Dental, and Vision Coverage Flexible Spending Account (FSA) Life Insurance 401(k) Savings Plan Employee Stock Purchase Plan Employee Assistance Plan (EAP) Parental Leave Program Free Bausch + Lomb Contact Lenses Group Legal Services Education Assistance Program Adoption Benefits All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender identity, national origin, disability, or veteran status. For U.S. locations that require disclosure of compensation, the starting pay for this role is between $110,000.00 and $130,000.00. U.S. based employees may be eligible for short‑term and/or long‑term incentives. They may also be eligible to participate in medical, dental, vision insurance, disability and life insurance, a 401(k) plan and company match, a tuition reimbursement program (select degrees), company holidays, and well‑being benefits, among others. U.S. based employees are also eligible to receive sick time, floating holidays and paid vacation.
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