Executive Director, Head of Global Labeling & Ad/Promo Regul

Company: Merck
Location: Billerica
Posted on: February 22, 2021

Job Description:

Experience the joy of curiosity, search for a job Click here for additional search options Executive Director, Head of Global Labeling & Ad/Promo Regulatory A career at our company is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe. Your role:--In this role you--provide strategic leadership and oversight to Labeling and--Ad/ Promo--activities, both in the US and abroad.--You will--manage a highly competent and technically skilled team, comprised of 20-25 internal and external resources, and--a functional budget of over $5 million.--Reporting to the Head of Global Regulatory Affairs,--you will work--closely with--key internal stakeholders including--commercial, medical affairs, legal and compliance, corporate affairs, and patient advocacy to ensure external product and disease state communications are both effective and compliant.--This position--ensures--delivery of innovative--and--quality--& compliant labeling of our products globally,--of compliant regulatory review of--Ad/ Promo--materials for--both--the US--and Global--markets,--and ensures--effective supplier management related to functional area sourced activities.---In this role--you will build--a strong leadership and functional capability to keep pace with the changing science and regulatory environment.--You will--establish an effective implementation and oversight model to maintain best in industry regulatory compliance as well as effective utilization of digital approaches and technologies to drive in-depth regulatory insights--for our--products. Who You Are:-- Required Qualifications: You completed a--BS degree in life sciences or related scientific discipline-- You gained--15+--years' experience in Regulatory Affairs (8+ in--US Ad/Promo--and labeling strategy), Nonclinical Research, or Clinical Research, specifically, in the submission of regulatory filings for drug/--biologic products. You possess working knowledge of FDA and--International--Biologics/--Drug regulations; experience with IND, CTA, BLA, NDA, MAA, eCTD, and 2253 regulatory submissions. You have proven experience in driving--change and innovation You--have the ability to--travel domestically and internationally Preferred Qualifications An advanced degree--(MS, JD, PharmD, PhD, etc.) Experience with combination (i.e., drug/device or biologic/device), biologics or drug products and oncology is preferred. What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life! The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination. Job Requisition ID: 214011 Career Level: D - Professional (4-9 years) Working time model: full-time Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone's health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options. US Disclosure
The Company is an Equal Employment Opportunity--employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination. North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from--8:00am--to--5:30pm--ET Monday through Friday.

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