Executive Director, Head of Global Labeling & Ad/Promo Regul
Company: Merck
Location: Billerica
Posted on: February 22, 2021
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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.
Keywords: Merck, Billerica , Executive Director, Head of Global Labeling & Ad/Promo Regul, Executive , Billerica, Massachusetts
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