Merck Organon – Associate Director, Submissions Planning & Regulatory Intelligence in Helena, Montana
We intend to move this position to Organon when it becomes an independent company. For this exciting new opportunity, we are 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 women’s well-being.
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 cardiovascular portfolio.
- 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 Intelligence capabilities.
Operates the business system capabilities of the regulatory organization, partnering with other internal Research & Development functions, as well as external parties (partners, vendors), where appropriate.
Leads projects and initiatives supporting the long-term vision and strategy for business operations enabled by regulatory information management systems/capabilities, helping to drive business outcomes.
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 operations.
Represents the strategic operations organization at both internal and external forums on regulatory business systems capabilities.
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
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, Microsoft Project)
Knowledge of regulatory requirements management and/or knowledgebase tools/platforms
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 filings
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 cross-geographically based cultural 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.
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.
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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.
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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
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Number of Openings:
Requisition ID: R108297