Senior Specialist, Advertising And Promotion Regulatory Affairs

Merck & Co., Inc. North Wales , PA 19454

Posted 2 months ago

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, subject to applicable law.

The Senior Specialist is responsible for the review and approval of US promotional materials for compliance with the letter and spirit of FDA regulations and our company's policies and standards.

As a member of the Promotion Review Team (PRT), works collaboratively with the Legal and Medical review team, Compliance, and Commercial colleagues to ensure that promotional practices are consistent with regulatory guidelines, company policies, and support business objectives.

Review and approve promotional materials for submission to FDA in a timely manner and in accordance with FDA regulations.

Provide promotional regulatory input on concepts and draft materials to help assure promotional materials satisfy U.S. promotional regulations, corporate standards and policies and business objectives.

Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters, and policy issues affecting the pharmaceutical/biologics industry.

Work closely with Regulatory Operations/ Submissions Team , as needed, to create and submit advisory requests.

Maintain a productive relationship with FDA to help ensure successful and timely review of advisory submissions and effective resolution of regulatory actions.

Under the direction of the Team Leader: develop and implement effective strategies for FDA promotional submissions; manage the development of correspondence with FDA and the interpretation of FDA advisory comments.

Communicate significant changes in FDA perspective to relevant stakeholders.

Contribute Ad/Promo experience to the development of optimal FDA labeling on original and supplemental New Drug Applications and/or Biologics License Applications.

Identifies and contributes to departmental or cross-functional initiatives to ensure effective and efficient promotional review practices.

Minimum Requirements:

  • B.A. or B.S. in scientific or related major.

  • Minimum 2 years' experience in pharmaceutical/biologics industry or related field, preferably in the regulatory, scientific, medical, legal or marketing disciplines.

  • Understanding of FDA regulations relating to advertising and promotion for prescription products with a steadfast focus on quality & compliance.

  • Fundamental understanding of the pharmaceutical industry drug development process, including labeling development.

  • Understanding of the process of pharmaceutical promotional development and review processes.

  • Strong verbal and written communication skills.

  • Attention to detail and ability to manage multiple priorities simultaneously.

  • Strong interpersonal skills with ability to use analytical problem-solving tools and techniques to surface and solve issues; Effectively partners within and outside the department.

  • Demonstrates an ability to negotiate and influence others without direct authority.

  • Action oriented with strong Cross-functional collaboration skills.

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.

GRACSJOBS

Current Employees apply HERE

Current Contingent Workers apply HERE

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 if you need an accommodation during the application or hiring process.

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

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

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:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

3

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VIEW JOBS 10/28/2021 12:00:00 AM 2022-01-26T00:00 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, subject to applicable law. The Senior Specialist is responsible for the review and approval of US promotional materials for compliance with the letter and spirit of FDA regulations and our company's policies and standards. As a member of the Promotion Review Team (PRT), works collaboratively with the Legal and Medical review team, Compliance, and Commercial colleagues to ensure that promotional practices are consistent with regulatory guidelines, company policies, and support business objectives. Review and approve promotional materials for submission to FDA in a timely manner and in accordance with FDA regulations. Provide promotional regulatory input on concepts and draft materials to help assure promotional materials satisfy U.S. promotional regulations, corporate standards and policies and business objectives. Maintain current awareness of evolving FDA regulations and interpretations, FDA advisory letters, enforcement letters, and policy issues affecting the pharmaceutical/biologics industry. Work closely with Regulatory Operations/ Submissions Team , as needed, to create and submit advisory requests. Maintain a productive relationship with FDA to help ensure successful and timely review of advisory submissions and effective resolution of regulatory actions. Under the direction of the Team Leader: develop and implement effective strategies for FDA promotional submissions; manage the development of correspondence with FDA and the interpretation of FDA advisory comments. Communicate significant changes in FDA perspective to relevant stakeholders. Contribute Ad/Promo experience to the development of optimal FDA labeling on original and supplemental New Drug Applications and/or Biologics License Applications. Identifies and contributes to departmental or cross-functional initiatives to ensure effective and efficient promotional review practices. Minimum Requirements: * B.A. or B.S. in scientific or related major. * Minimum 2 years' experience in pharmaceutical/biologics industry or related field, preferably in the regulatory, scientific, medical, legal or marketing disciplines. * Understanding of FDA regulations relating to advertising and promotion for prescription products with a steadfast focus on quality & compliance. * Fundamental understanding of the pharmaceutical industry drug development process, including labeling development. * Understanding of the process of pharmaceutical promotional development and review processes. * Strong verbal and written communication skills. * Attention to detail and ability to manage multiple priorities simultaneously. * Strong interpersonal skills with ability to use analytical problem-solving tools and techniques to surface and solve issues; Effectively partners within and outside the department. * Demonstrates an ability to negotiate and influence others without direct authority. * Action oriented with strong Cross-functional collaboration skills. 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. GRACSJOBS Current Employees apply HERE Current Contingent Workers apply HERE 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 if you need an accommodation during the application or hiring process. For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster EEOC GINA Supplement OFCCP EEO Supplement 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: Flexible Work Arrangements: Shift: Valid Driving License: Hazardous Material(s): Number of Openings: 3 Merck & Co., Inc. North Wales (Upper Gwynedd) PA

Senior Specialist, Advertising And Promotion Regulatory Affairs

Merck & Co., Inc.