Director Regulatory Operations - Process Operational Excellence
Company: Organon & Co.
Location: Jersey City
Posted on: June 22, 2022
|
|
Job Description:
**Job Description**Organon is a Women's Health Company that
believes in a better and healthier every day for every woman! We
are a passionate, global community of thousands dedicated to
redefining the future of women's health. Our mission is to deliver
impactful medicines and solutions for a healthier every day. But
what really makes it work at Organon is our people.We're looking
for real, passionate team players, curious innovators, forward
thinkers, empowered by the idea of shaping their career, and ready
to bring their fire to embrace change and the opportunities it
brings for progress.At Organon, you'll get to enjoy the best of
both worlds: the open, agile, collaborative culture of a start-up,
and operating at the scale of a fortune 500 company with an
international footprint that serves people in more than 140
markets.It's going to be an exciting future-come be a part of
it!Organon is looking for a **Director Regulatory Operations,
Process Operational Excellence** . The role will report to the
Executive Director of Regulatory Operations for Europe, Middle
East, and Africa (EMEA) within Regulatory Operations within
Regulatory Affairs and affiliate Pharmacovigilance in the Research
and Development organization of Organon & Co.**About the role**This
role will provide support across global Regulatory Operations
activities, specifically in the continuous improvement of
processes, assessment and update of process documentation, and the
development of process training and support resources. The role
will be accountable for the delivery of a portfolio of process
improvement projects and the appropriate prioritization,
sequencing, and resourcing of those projects.It will be important
for this role to be a conduit of information between the Regulatory
Affairs and Affiliate Pharmacovigilance (RAaPV) leadership and the
functional areas, regions, and individual process owners across the
organization. There is also an expectation to coordinate with key
stakeholders in the Quality and Compliance organization, Organon
Research and Development (ORD) Business Process Owner Network,
Learning and Development, and colleagues in other ORD departments
playing similar process roles.A key focus will be providing
leadership, support and subject matter expertise (SME) to process
owners throughout RAaPV.**Primary Responsibilities**+ Serves as
Project Lead for Process Operational Excellence+ Responsible to
define the portfolio of process improvement projects+ Prioritize
and sequence the work to deliver maximum impact to the business
while balancing resource constraints+ Provide teams with strategic
direction and guidance in best practices in process improvement and
Lean/Six Sigma principles+ Engage with external network to bring in
industry best practices and with ORD Learning and Development to
incorporate new training concepts+ Liaise with Director of
Processes and Quality Business Partner in Quality and Compliance
organization+ Support development of ORD Business Process Owner
Network and coordinate RAaPV participation+ Independently identify,
assess and actively resolve or escalate where necessary any risks
or issues that could impact the successful completion of regulatory
activities+ Proactively and creatively problem-solves, makes
effective and timely decisions while skillfully negotiating to
resolve conflicts across functions and between stakeholders+
Ensures project data, including information used to maintain
compliance and aid with strategic planning, is accurately reported
in databases+ Assume the lead role in the development of processes
and documentation. Delegate these project activities to subject
matter experts within the department as needed.+ Assume the role of
subject matter expert for specific functions or processes,
interacting and mentoring both within the department and with
external stakeholders+ Assist with departmental metrics by tracking
status of projects, day-to-day production activities, and
anomalies.+ Continuously develops and improves leadership and
project management skillsets, understanding of
drug/vaccine/biologics/device development, and regulatory
practices**Role requirements:**+ Required: Bachelor's degree plus 8
years of operations experience (pharmaceutical regulatory affairs a
plus)+ Preferred: Bachelor's degree plus 10-12 years of
pharmaceutical regulatory operations experience (MBA or advanced
degree in process engineering is considered a plus)+
Detail-orientation with the ability to understand the "big picture"
and overall strategy of projects/programs+ Experience with project
management and leading teams+ Program management and influencing
without authority+ Authoring effective process documentation and
driving continuous process improvement+ Proven track record to be
able to think critically, strategically, independently and problem
solve+ High level of motivation, drive, and demonstration of
Organon leadership values+ Excellent written and verbal
communication skills including ability to write clearly and
concisely to executive audiences+ Top notch interpersonal skills in
difficult situations+ Driver of change and innovation+ Ability to
work seamlessly with all levels of personnel+ Demonstrated
sensitivity and knowledge of cultural differences with experience
in multi-country, multi-cultural environments and demonstrated
success with global collaborations+ Excellent word processing,
sharepoint, excel, e-mail, and online meeting tool skills**Who We
Are:**Organon delivers ingenious health solutions that enable
people to live their best lives. We are a $6.5 billion global
healthcare company focused on making a world of difference for
women, their families and the communities they care for. We have an
important portfolio and are growing it by investing in the unmet
needs of Women's Health, expanding access to leading biosimilars
and touching lives with a diverse and trusted portfolio of health
solutions. Our Vision is clear: A better and healthier every day
for every woman.Subject to applicable law, all prospective US
Organon hires will be required to demonstrate that they have been
fully vaccinated against COVID-19 with a vaccine authorized or
approved by the Food and Drug Administration (FDA), or qualify for
a medical or religious accommodation to this vaccination
requirement, as a precondition of employment.**Residents of
Colorado:** to request this role's pay range: email:
coloradopayact@organon.comJersey City and New York City Positions:
to request this role's pay range and benefits, email:
jcnycpay@organon.com .**US and PR Residents Only**If you require
reasonable accommodation(s) in completing an application,
interviewing, or otherwise participating in the employee selection
process, please email us at staffingaadar@organon.com .For more
information about personal rights under Equal Employment
Opportunity, visit:EEOC PosterEEOC GINA SupplementOFCCP EEO
SupplementOFCCP Pay Transparency RuleOrganon is an equal
opportunity employer, Minority/Female/Disability/Veteran - proudly
embracing diversity in all of its manifestations.**Search Firm
Representatives Please Read Carefully**Organon LLC., 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:****Travel
Requirements:**10%**Flexible Work Arrangements:**Remote
Work**Shift:****Valid Driving License:****Hazardous
Material(s):****Number of Openings:**1**Requisition ID:**
R509955
Keywords: Organon & Co., Jersey City , Director Regulatory Operations - Process Operational Excellence, Executive , Jersey City, New Jersey
Click
here to apply!
|