What are the responsibilities and job description for the REMOTE Sr. Specialist, Global Labeling Lead (GLL) position at Merck?
**Job Description**
The purpose of the Global Labeling Therapeutic Area group is to drive labeling strategy and ensure high-quality and compliant labeling documents, which provide the safe and effective use of products for patients and healthcare providers globally. The Global Labeling Therapeutic Area group is accountable for developing labeling content and maintaining the target product labeling for developmental products, Core Labeling documents (e.g., CCDS, CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling and other country's Local Labeling. This position is 100% remote.
**As part of the Global Labeling Therapeutic Area, and under the supervision of the Global Labeling Strategic Director, the GLL is responsible for:**
Developing, maintaining, and implementing Core Labeling for assigned products in line with internal standards and guidelines
Developing, maintaining, and implementing US Labeling for assigned products in line with regulatory requirements and internal standards and guidelines
Assisting with developing and maintaining Local Labeling (EU and most of world) for assigned products
Providing labeling expertise and guidance to teams while ensuring compliance with applicable regulatory requirements
Serving as regulatory labeling point of contact on global Regulatory Affairs sub-teams to ensure delivery of labeling documents that meet quality and compliance standards and regulatory labeling requirements to support timely regulatory submissions for assigned products
Leading cross-functional teams to develop, review and approve Core and Local Labeling documents
Recommending strategies and labeling language for inclusion in Core or Local Labeling during labeling development or responses to Health Authority
**Position Qualifications:**
Bachelor's degree in a scientific discipline is required. Advanced degree preferred (MS, PharmD, PhD).
Minimum of 3 years of labeling experience or relevant experience in the pharmaceutical industry (e.g., Medical Affairs, Regulatory Affairs, Clinical, Pharmacovigilance).
**Competencies include:**
Project management skills with the ability to handle multiple projects and prioritize work accordingly.
Tolerance for ambiguity and action-oriented.
Strong written and oral communication skills.
Attention to detail and accuracy.
Ability to influence and negotiate.
Ability to distill an issue into critical components and suggest solutions.
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., Rahway, 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 ...**
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.
**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 ([ Link removed ] - Click here to apply to REMOTE Sr. Specialist, Global Labeling Lead (GLL) to request this role's pay range.
**For positions located in the United States and Puerto Rico - Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) ("Customer-Facing Role") who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.**
Current Employees apply HERE ([ Link removed ] - Click here to apply to REMOTE Sr. Specialist, Global Labeling Lead (GLL) />
Current Contingent Workers apply HERE ([ Link removed ] - Click here to apply to REMOTE Sr. Specialist, Global Labeling Lead (GLL) />
**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 ([ Link removed ] - Click here to apply to REMOTE Sr. Specialist, Global Labeling Lead (GLL) if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Know Your Rights ([ Link removed ] - Click here to apply to REMOTE Sr. Specialist, Global Labeling Lead (GLL) />
EEOC GINA Supplement?
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_ English\_formattedESQA508c.pdf)
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.
Under New York City, Washington State and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range:
$96,700.00 - $164,500.00
For Washington State Jobs, a summary of benefits is listed here ([ Link removed ] - Click here to apply to REMOTE Sr. Specialist, Global Labeling Lead (GLL) .
Learn more about your rights, including under California, Colorado and other US State Acts ([ Link removed ] - Click here to apply to REMOTE Sr. Specialist, Global Labeling Lead (GLL) />
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:**
**Flexible Work Arrangements:**
Remote Work
**Shift:**
1st - Day
**Valid Driving License:**
**Hazardous Material(s):**
**Number of Openings:**
3
**Requisition ID:** R202880
The purpose of the Global Labeling Therapeutic Area group is to drive labeling strategy and ensure high-quality and compliant labeling documents, which provide the safe and effective use of products for patients and healthcare providers globally. The Global Labeling Therapeutic Area group is accountable for developing labeling content and maintaining the target product labeling for developmental products, Core Labeling documents (e.g., CCDS, CCPPI, CCIFU) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU Labeling and other country's Local Labeling. This position is 100% remote.
**As part of the Global Labeling Therapeutic Area, and under the supervision of the Global Labeling Strategic Director, the GLL is responsible for:**
Developing, maintaining, and implementing Core Labeling for assigned products in line with internal standards and guidelines
Developing, maintaining, and implementing US Labeling for assigned products in line with regulatory requirements and internal standards and guidelines
Assisting with developing and maintaining Local Labeling (EU and most of world) for assigned products
Providing labeling expertise and guidance to teams while ensuring compliance with applicable regulatory requirements
Serving as regulatory labeling point of contact on global Regulatory Affairs sub-teams to ensure delivery of labeling documents that meet quality and compliance standards and regulatory labeling requirements to support timely regulatory submissions for assigned products
Leading cross-functional teams to develop, review and approve Core and Local Labeling documents
Recommending strategies and labeling language for inclusion in Core or Local Labeling during labeling development or responses to Health Authority
**Position Qualifications:**
Bachelor's degree in a scientific discipline is required. Advanced degree preferred (MS, PharmD, PhD).
Minimum of 3 years of labeling experience or relevant experience in the pharmaceutical industry (e.g., Medical Affairs, Regulatory Affairs, Clinical, Pharmacovigilance).
**Competencies include:**
Project management skills with the ability to handle multiple projects and prioritize work accordingly.
Tolerance for ambiguity and action-oriented.
Strong written and oral communication skills.
Attention to detail and accuracy.
Ability to influence and negotiate.
Ability to distill an issue into critical components and suggest solutions.
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., Rahway, 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 ...**
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.
**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 ([ Link removed ] - Click here to apply to REMOTE Sr. Specialist, Global Labeling Lead (GLL) to request this role's pay range.
**For positions located in the United States and Puerto Rico - Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) ("Customer-Facing Role") who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.**
Current Employees apply HERE ([ Link removed ] - Click here to apply to REMOTE Sr. Specialist, Global Labeling Lead (GLL) />
Current Contingent Workers apply HERE ([ Link removed ] - Click here to apply to REMOTE Sr. Specialist, Global Labeling Lead (GLL) />
**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 ([ Link removed ] - Click here to apply to REMOTE Sr. Specialist, Global Labeling Lead (GLL) if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Know Your Rights ([ Link removed ] - Click here to apply to REMOTE Sr. Specialist, Global Labeling Lead (GLL) />
EEOC GINA Supplement?
Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\_ English\_formattedESQA508c.pdf)
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.
Under New York City, Washington State and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range:
$96,700.00 - $164,500.00
For Washington State Jobs, a summary of benefits is listed here ([ Link removed ] - Click here to apply to REMOTE Sr. Specialist, Global Labeling Lead (GLL) .
Learn more about your rights, including under California, Colorado and other US State Acts ([ Link removed ] - Click here to apply to REMOTE Sr. Specialist, Global Labeling Lead (GLL) />
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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:**
**Flexible Work Arrangements:**
Remote Work
**Shift:**
1st - Day
**Valid Driving License:**
**Hazardous Material(s):**
**Number of Openings:**
3
**Requisition ID:** R202880
Recommended Skills
- Attention To Detail
- Clinical Works
- Communication
- Health Care
- Leadership
- Maintenance
Salary : $96,700 - $164,500
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