Organon - Associate Director, Submissions Planning & Regulatory Intelligence
Company: The American College of Radiation Oncology
Posted on: April 2, 2021
- Organon - Associate Director, Submissions Planning & Regulatory
Intelligence M Organon - Associate Director, Submissions Planning &
Regulatory Intelligence DescriptionJob Description
We intend to move this position to Organon when it becomes an
independent company. For this exciting new opportunity, weare
seeking candidates with an entrepreneurial and learning spirit who
are interested in a career of purpose, personal growth and
leadership. Working together, we will make a significant impact on
the health and lives of people around the world. Organon will
improve the lives of people globally by unleashing the promise of
trusted brands across women's health and other important
therapeutic areas. We are committed to becoming the world's leading
women's health company investing in innovations that support
- Invest in innovations to support women's well-being, fueled by
our leading contraceptives and fertility business.
- Establish a leading position in biosimilars, focusing on
oncology and inflammatory diseases, and being a partner in the
commercialization of biosimilars worldwide.
- Realize the value of trusted dermatology, pain and
- This position will report to the Executive Director of
Regulatory Affairs Business Systems Oversight within Innovation &
Information Management within Strategic Operations in the Research
and Development organization of Organon & Co.
The Associate Director of Regulatory Business Systems Oversight is
accountable and responsible for the following activities:
- Provides industry expertise and practical knowledge of current
and emerging technologies and process approaches within regulatory,
including, but not limited to, Submission Planning and Regulatory
- Operates the business system capabilities of the regulatory
organization, partnering with other internal Research & Development
functions, as well as external parties (partners, vendors), where
- Leads projects and initiatives supporting the long-term vision
and strategy for business operations enabled by regulatory
information management systems/capabilities, helping to drive
- Influences leaders to see new opportunities for enhanced
regulatory business system capabilities.
- Proactively identifies new capabilities and enhancements that
will improve regulatory and broader Research & Development
- Represents the strategic operations organization at both
internal and external forums on regulatory business systems
- Ensures high ethical standards and a culture that values
honesty, integrity, and transparency.
10% travel to Pennsylvania / New Jersey (possible other domestic
and international travel)
Education Minimum Requirements:
- Bachelor's degree in a business, scientific, or operational
discipline relevant to the life sciences and/or operations areas is
Required Experience and Skills:
- 5+ years of leading regulatory business systems capabilities
within a research and development organization
- 3+ years of experience in a regulated research and development
environment, preferably in regulatory affairs
- Must have proven track record to be able to think critically,
strategically, independently and problem solve
- Must have high level of motivation, drive, and demonstration of
Organon leadership values
- Excellent written and verbal communication skills including
ability to write clearly and concisely
- Top notch interpersonal skills in difficult situations
Preferred Experience and Skills:
- Knowledge of planning for submissions/filings to domestic and
global health authorities and requisite tools (eg, Liquent Insight
for Submissions Management, EXTEDO Planning & Tracking Hub,
- Knowledge of regulatory requirements management and/or
- Knowledge of regulatory intelligence knowledgebase
tools/platforms (eg, Cortellis)
- Knowledge of enterprise content management
- Knowledge of CMC, labeling, promotional materials, and
drug/device product dossier lifecycle management and
- Driver of change and innovation
- Ability to work seamlessly with all levels of
- Demonstrated sensitivity and knowledge of cultural differences
with experience in multi-country, multi-cultural environments and
demonstrated success with cross-geographically based cultural
- 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
Our Vision is clear: A better and healthier every day for every
At launch, we will be more than 10,000 Founders strong, ready to
rise together as we make a difference in a new way. As Founders,
employees will create their future and will help shape the
direction of Organon and its impact on the world. Our culture
reflects our passion for those we champion.
At Organon, we all belong. We embrace diversity and give it a
voice. Our commitment to supporting women is reflected in the
make-up of our leadership team, which is majority female and our
diversity of experience is core to who we are and what we are
designed to do.
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
We are an equal opportunity employer, committed to fostering an
inclusive and diverse workplace.
Residents of Colorado
Click here to request this role's pay range.
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
EEOC GINA Supplement
OFCCP EEO Supplement
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.
Flexible Work Arrangements:
1st - Day
Valid Driving License:
Number of Openings:
- Job ID: 56302896
Redding, California, United States
- Position Title: Organon - Associate Director, Submissions
Planning & Regulatory Intelligence
- Company Name: Merck & Co., Inc.
- Job Function: Other
- Job Type: Full-Time Jobs You May Like M Merck & Co., Inc.
Redding, CA, United States M Merck & Co., Inc. Redding, CA, United
States M 2001 6th Ave, Suite 2700 Seattle, Washington 98121 (206)
Keywords: The American College of Radiation Oncology, Redding , Organon - Associate Director, Submissions Planning & Regulatory Intelligence, Executive , Redding, California
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