Organon - Director, Business Process Lead and Regulatory Strategy ( MERCUSR113688ENUS)
Job DescriptionOur Regulatory Affairs team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world.
Primary Responsibilities include:
Assisting US Head of Regulatory in assessing industry-leading staffing models and capacity management capabilities within the region including leading analysis of staffing and resource plans for business development deals and key strategy and innovation programs (such as digital transformation, strategic alliances)
Work closely with HR and Finance Business Partners to deliver budget and headcount plans on target, with accountability for making decisions and informing HR and Finance regarding reallocations, reprioritizations and trade-off's.
Organize and coordinate Operating Reviews for the company, and with cross-divisional partners, with accountability for driving key changes required
Lead the preparation of high-quality presentations for both internal and external audiences
Working with the Global and Regional Leadership Teams to identify, recruit and engage members of the strategic working groups; ensuring relevant skills are aligned to support delivery of the strategic objectives
Lead the management and production scorecard, goals and dashboards, and ensure the ongoing effective communication of filing plans and progress on other strategic priorities to global senior leadership stakeholder groups across all divisions
Contributing to the delivery of the strategic objectives through direct involvement/delivery of key tasks and objectives
Serve as Global Regulatory Lead as needed for assigned products to
Develop regulatory strategy for assigned products, in order to optimize label and obtain shortest time to approval by regulatory agencies.
Independently manage projects functioning as the single, accountable, global point of contact on those projects.
Independently interact with worldwide regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more our company's investigational and marketed drugs.
Coordinate the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions.
Conduct regulatory review and final approval of all submissions and associated documentation.
Provide expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and outside.
Additional responsibilities and desirable characteristics:
Participate in projects outside of current responsibilities as needed to drive the organization forward to success
Contribute to determining solutions outside of current responsibilities as needed and manage day-to-day operational issues outside of current responsibilities as needed
Work seamlessly with other R&D departments as well as commercial organization and manufacturing organizations
Driver of innovative and creative solutions for achieving R&D goals and objectives in a high quality and cost-effective manner.
Must be able to support highly complex multiple activities simultaneously
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 our company's leadership values
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 cross-geographically based cultural collaborations
Ph.D. or M.D. with 5 years relevant drug development experience required preferably with 3 years in Regulatory OR
M.S. or B.S. with 7 years relevant drug development experience, a majority of which was in Regulatory
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.
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 Acquisition Advisor.
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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.
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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.
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Number of Openings:1