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Merck REMOTE - Global Labeling Lead - Associate Director, Oncology in Helena, Montana

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.

New hires based in the US & Puerto Rico will be required to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption or accommodation to this vaccination requirement, subject to applicable law.”

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world. Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

As part of the Oncology Team in the Global Labeling Therapeutic Areas, and under the supervision of the Director Global Labeling Strategy, 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 CCDS 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. This

position is 100% remote.

Responsibilities may include, but are not limited to:

  • Overall accountability for the initial creation and updates to labeling documents for assigned products including development of target product labels, development and maintenance of CCDS, US labeling, and associated patient labeling documents. 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.

  • Overall project management for the labeling process including for the 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 CCDS 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 CCDS, 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.

  • Supports the use and development of current and new tools, technologies and processes to support efficient global label development and worldwide submissions and approvals.

Minimum Education Requirement:

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

Required Skills and Experience:

  • Minimum of 6 years of pharmaceutical or relevant experience with a focus on product labeling inclusive of regulatory product labeling (CCDS, US and EU labeling) requirements for marketed products.

  • Advanced understanding of the scientific principles of the drug development process.

  • Effective critical thinking and problem solving skills.

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

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

  • Proven ability to lead effective, well-integrated, collaborative teams and drive teams to consensus and results.

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

  • Proven ability in medical writing.

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

  • Desire to lead dynamic, multi-disciplinary teams in a fast-paced environment.

GRACSJOBS

#EligibleforERP

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

Click here (https://survey.sogosurvey.com/r/O2fDro) to request this role’s pay range.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

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

EEOC Poster (https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf)

EEOC GINA Supplement​

OFCCP EEO Supplement (https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf)

Pay Transparency Nondiscrimination

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:

2

Requisition ID: R134467

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