Pharmaceutical Labeling Operations Manager, Manager

1 month ago


La Jolla, United States Pfizer Full time
The Labeling Operations Manager (LOM) provides operational support for the initial creation and relevant updates to labeling documents including the Core Data Sheets (CDS), United States Package Inserts (USPI), Summary of Product Characteristics (SPC) for products registered in the EU via the Centralized, Mutual Recognition or Decentralized

Procedures, and their associated Patient Labeling Documents. The Labeling Operations Manager, Manager is capable of managing a large volume of projects which can be highly complex.

The LOM will be knowledgeable of labeling guidance and policies related to technical/formatting (e.g. QRD template, PLR format) and will raise awareness of important factors to consider when revising the label.

The LOM provides project management to the Labeling Team throughout the labeling review and approval process through notification to stakeholders in order to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements. This includes setting clear targets, ensuring that Labeling Teams are aware of the review and approval timelines and following up with Labeling Team members

throughout the process as appropriate so that deliverables remain on target to meet internal and external deadlines.

Education:
  • Bachelor's degree in a science or life sciences preferred or equivalent practical experience.

    Experience and Attributes:
    • 4-6 years experience in a regulated environment;
    • Minimum 1-2 years global or regional pharmaceutical labeling experience required

      Work Location Assignment:On premise

      The annual base salary for this position ranges from $88,300.00 to $147,100.00.* In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

      * The annual base salary for this position in Tampa, FL ranges from $79,500.00 to $132,500.00.

      Relocation assistance may be available based on business needs and/or eligibility.

      Sunshine Act

      Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

      EEO & Employment Eligibility

      Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.

      Regulatory Affairs

  • Operations Manager

    6 days ago


    La Jolla, California, United States Blue Bowl Superfoods Llc Full time

    Job OverviewABOUT BLUE BOWL SUPERFOODSBlue Bowl Superfoods is a unique cafe concept that allows customers to create their own superfood bowls, offering a variety of nutritious and delicious options. With a strong presence across multiple locations, we pride ourselves on delivering exceptional service and high-quality products that cater to health-conscious...


  • La Jolla, California, United States Aerotek Full time

    Job OverviewAerotek is seeking a highly organized and detail-oriented Material Handler to join our team. As a Material Handler, you will play a critical role in ensuring the smooth operation of our warehouse by managing inventory, processing orders, and maintaining a safe and efficient work environment.Key ResponsibilitiesPicking and Receiving: Accurately...


  • La Jolla, United States Pfizer Full time

    WHY PATIENTS NEED YOU Pfizer's purpose is to deliver breakthroughs that change patients' lives. Research and Development is at the heart of fulfilling Pfizer's purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or...


  • La Jolla, California, United States Superior Talent Source Full time

    Job OverviewWe are seeking a seasoned Restaurant Operations Manager to lead our high-volume casual dining location to continued success. As a key member of our management team, you will be responsible for overseeing daily restaurant operations, ensuring exceptional guest experiences, and driving business growth.Key Responsibilities:Manage and oversee the...


  • La Jolla, California, United States Noble House Estancia LLC Full time

    Job OverviewPosition Summary:The Culinary Operations Manager plays a pivotal role in assisting the Executive Chef in overseeing all aspects of culinary services within the establishment. This includes the strategic planning, preparation, production, and presentation of food, ensuring the highest standards of quality and guest satisfaction. The role...


  • La Jolla, California, United States Longboard Pharmaceuticals, Inc. Full time

    Position OverviewLongboard Pharmaceuticals, Inc. is in search of a Site Engagement and Enrollment Manager focused on the North American region. This pivotal role is centered around establishing and nurturing strategic partnerships with essential clinical sites.Key ResponsibilitiesDevelop and maintain robust relationships with key stakeholders at clinical...


  • La Jolla, California, United States La Jolla Beach & Tennis Club Full time

    Financial Operations Manager Opportunity at La Jolla Beach & Tennis ClubThe La Jolla Beach & Tennis Club is seeking a proficient Financial Operations Manager to enhance our team at our picturesque oceanfront venue.Become part of the vibrant team at La Jolla Beach & Tennis Club, Inc. Our esteemed hotels and dining establishments are deeply rooted in La Jolla,...


  • La Jolla, California, United States LA Jolla Beach & Tennis Club Full time

    Join Our Team as an Event Operations ManagerThe La Jolla Beach & Tennis Club is on the lookout for a dedicated Event Operations Manager to lead our banquet department at our stunning oceanfront venue. Become part of a diverse team that embodies family values and community spirit, contributing to our esteemed reputation in La Jolla. We offer competitive...


  • La Jolla, California, United States Regents Pizzeria Full time

    About the RoleWe are seeking a highly skilled and experienced Assistant Manager to join our team at Regents Pizzeria. As a key member of our leadership team, you will play a crucial role in the day-to-day operations of our restaurant, ensuring that we deliver exceptional customer experiences and maintain our high standards of quality and service.Key...


  • La Jolla, California, United States Museum of Contemporary Art San Diego Full time

    Job DescriptionMuseum of Contemporary Art San Diego: Financial Operations ManagerDepartment: Business OfficeReports to: Chief Financial OfficerEmployee Status: Full-Time (30-Hour Work Week), Exempt Primary Work Location: On-sitePay Range: Competitive SalaryJOB SUMMARY: Oversee the financial operations of the Museum, ensuring the timely production of...


  • La Jolla, California, United States Curo Pet Care Full time

    Job OverviewCuro Pet Care is seeking a seasoned professional to take on the role of Regional Veterinary Operations Manager. This position will focus on the comprehensive oversight and administration of our veterinary facilities across the designated regions. The successful candidate will play a crucial role in the enhancement and expansion of our...


  • La Crosse, Wisconsin, United States The Mayo Clinic Full time

    Position OverviewThe Pharmacy Operations Manager plays a crucial role within the pharmacy leadership team, overseeing the management of pharmacy services and operations. This position is essential for ensuring the effective delivery of pharmaceutical care.Key ResponsibilitiesManage daily pharmacy operations to ensure high-quality service delivery.Supervise...


  • La Jolla, California, United States La Jolla Beach & Tennis Club Full time

    Job OverviewThe La Jolla Beach & Tennis Club is in search of a dedicated Banquet Manager to oversee our exceptional event services at our stunning oceanfront venue.Join our diverse team at La Jolla Beach & Tennis Club, Inc., where our renowned hotels and dining establishments are built on strong family values and a commitment to community. We pride ourselves...


  • La Jolla, California, United States Marriott La Jolla Full time

    About Us: Experience the blend of luxury and comfort at the San Diego Marriott La Jolla. Our contemporary hotel is strategically located near stunning attractions such as La Jolla Shores and Birch Aquarium. We take pride in providing our associates with complimentary meals in our spacious cafeteria and host monthly gatherings featuring delightful culinary...


  • La Jolla, California, United States Pfizer Full time

    Why Patients Need YouWe're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient...


  • La Jolla, United States Pfizer Full time

    Why Patients Need YouWe're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient...


  • La Jolla, United States Pfizer Full time

    Why Patients Need YouWe're looking to bring medicines to the world faster and we are not willing to compromise on excellence and integrity. Adhering to local and global regulations is essential and the ever-changing regulatory environment requires forward thinking and attention to detail. Your dedication and expertise will help expand and accelerate patient...


  • La Jolla, California, United States Salk Inc Full time

    Position OverviewThe Chief Operations Executive at Salk Inc. is responsible for managing all operational aspects of the organization, including facilities management, security operations, environmental health and safety, information technology, and event coordination. As a vital member of the Executive Leadership Team, this role collaborates closely with the...


  • La Jolla, California, United States Hilton Hotels & Resorts Full time

    Job SummaryWe are seeking a highly skilled and experienced Housekeeping Supervisor to join our team at Hilton Hotels & Resorts. As a key member of our housekeeping department, you will be responsible for leading and supervising a team of Room Attendants and Housepersons to deliver exceptional guest service and drive financial profitability.Key...


  • La Jolla, California, United States Salk Institute Full time

    Position OverviewThe Chief Operations Executive at the Salk Institute is responsible for overseeing all operational aspects, including facilities management, security services, environmental health and safety, information technology, and campus events. As a vital member of the Executive Leadership Team, this role collaborates closely with the President,...