Our Regulatory Affairs team bring 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.
As a key member of the Global Regulatory Affairs & Clinical Safety (GRACS) Leadership team, the VP/TA Head, Oncology RA's primary objectives will be to:
Collaborate and forge effective relationships with key external (e.g. FDA, EMA) and internal (e.g., Global Clinical Development) stakeholders
Influence to implement rigorous, innovative and science-based regulatory approaches to our highest priority programs and filings.
Function as internal authority on regulatory, scientific and strategic issues in the Oncology therapeutic area with outstanding negotiation skills and expectations for broad pipeline impact
Utilize enhanced business acumen that facilitates driving of decisions and strategies that are innovative and in our company's best interest
Serves as Research & Development/GRACS oncology representative on executive committees; lead, develop and coach a team of senior level regulatory professionals
Support business development strategy by validating unmet medical needs, reviewing asset data and recommending required regulatory resources
Champion rapid and effective decision making through empowerment of individuals
Increase effectiveness by enabling clear and concise communication directly to senior management and to regulatory authorities.
Ensure high ethical standards and a culture that values honesty, integrity, and transparency.
Advanced Degree (MD; PhD; DVM) with 12+ years in Oncology Regulatory Affairs.
Required Experience and Skills:
Multiple/varied experiences bringing a product through all cycles of development, including achieving product licensure.
Proven track record in aligning global regulatory strategies with corporate goals and providing critical therapeutic area insights.
A recognized expert in oncology regulatory affairs, demonstrating depth and breadth of knowledge and understanding of scientific, medical, and regulatory environments, practices and requirements.
Skilled in leveraging expert knowledge for scientific, technical, clinical and regulatory strategic thinking, problem solving and decision making in the evolving pharmaceutical environment.
Demonstrated ability to: lead and inspire teams: allocate resource strategically and according to portfolio priorities; attract, retain, engage and develop top talent.
Excellent communication and influencing skills in cross-cultural and cross-functional matrix settings.
Proven track record of profound people management, leadership and motivational skills.
Superior stakeholder management skills across scientific, academic, regulatory and scientific communities to identify and achieve mutual goals for the well-being of cancer patients.
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we "follow the science" that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are ...
We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for ...
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.
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.
For positions located in the United States and Puerto Rico - Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) ("Customer-Facing Role") who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.
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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 Opportunity, visit:
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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.
Under New York City, Washington State and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected salary range: $315,280.00 - $496,300.00 For Washington State Jobs, a summary of benefits is listed here .
Learn more about your rights, including under California, Colorado and other US State Acts
Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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.
Employee Status: Regular
Flexible Work Arrangements:
Valid Driving License:
Number of Openings: 1
To apply please click on APPLY TO THIS POSITION
Job Post Date: 01/22/23
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