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REMOTE - Global Labeling Lead, Sr. Specialist - Oncology

Job Description

Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.

The purpose of the Global Labeling Therapeutic Areas group is to drive labeling strategy and ensure high quality and compliant labeling documents which ensure the safe and effective use of products for patients and healthcare providers, globally. The Global Labeling Therapeutic Areas group is accountable for developing and maintaining the target product labeling for developmental products, the Core Labeling documents (e.g., CCDS, CCPPI) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU and most of world labeling.

As part of Global Labeling Therapeutic Areas, and under the supervision of the Global Labeling Strategic Director (GLSD) the Global Labeling Lead (GLL) is responsible for managing labeling of assigned products for developmental and marketed products, globally. This includes collaboration with the cross-functional labeling team to develop and maintain the Core Labeling and US labeling, including associated patient labeling documents, and the target product labeling. The GLL is also responsible for supporting local country affiliates on the development and maintenance of the EU and most of world labeling. The GLL provides regulatory labeling expertise, including knowledge of labeling regulations and guidance documents, competitive data, and company policies to cross-functional product labeling teams and other cross functional teams as needed to aid in review and approval of labeling. This position is 100% remote.

The GLL will also contribute to the development and improvement of the labeling group by participating on projects that enhance the processes and efficiency of the group, sharing knowledge and mentoring peers.

Responsibilities may include, but are not limited to:

  • Overall accountability for the initial creation and updates to labeling documents for assigned products including development and maintenance of Core Labeling, US labeling, and their associated patient labeling documents, and target product labels. Includes the responsibility to work cross-functionally and lead meetings to develop, review and approve labeling documents.

  • Operates as the primary point of contact on assigned products for all internal and external stakeholders to ensure timely regulatory submissions, quality and compliant labeling documents, and to support business objectives. Includes support required for audits/inspections related to assigned products.

  • Provides project management throughout the entire process, from the request to update Core Labeling/US labeling through notification to stakeholders, in order to ensure documents are produced in a timely manner according to internal operating procedures and external regulatory requirements. Includes the responsibility to manage communication plans, distribution of labeling documents, updates to labeling tracking reports and databases, and providing status updates to Global Labeling management.

  • Knowledgeable about key labeling requirements worldwide and ensures that country labeling documents are aligned with the Core Labeling or reference labeling documents.

  • Provides regulatory expertise and guidance for the development and submission of US labeling components. Controls the consistency of US labeling content through alignment with the Core Labeling, across product families where necessary, and with all applicable best practices.

  • Assists with creation/update of local product labeling (EU and most of world) for assigned products and interfaces with Regional Labeling Lead and local country affiliate colleagues to support timely and quality regulatory submissions and approvals globally.

  • Contributes and supports the continuous improvements to the end-to-end labeling process including labeling policies, processes, quality, and system tools.

Education Requirement:

  • Bachelor’s degree in a scientific or medically-related discipline required. Master’s degree preferred.

Experience:

  • Minimum of 4 years of pharmaceutical experience or relevant professional experience.

  • Labeling experience (CCDS, US, EU) in oncology or other relevant industry experience related to developing regulatory documentation.

  • Regulatory submission experience.

  • Process improvement and compliance/quality experience.

  • Ability to develop relationships and work well with others in demanding situations with a positive attitude.

  • Detail oriented, well organized, high project management skills.

  • Experience facilitating meetings and driving consensus and results.

  • Excellent leadership, communication (verbal and writing) and collaboration skills.

  • Proven ability in medical/technical writing.

  • Experience in Word, Excel and PowerPoint, and document management tools.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Residents of Colorado

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Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, 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. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Remote Work

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

3

Requisition ID:R134473

REMOTE - Global Labeling Lead, Sr. Specialist - Oncology

North Wales, PA 19454
Full Time

Published on 11/25/2021

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