at Merck in Dover, Delaware, United States
Job Description
Job Description
Attention NJ Applicants : In April 2020, our Company announced plans to consolidate our New Jersey campuses into a single New Jersey headquarters location in Rahway, NJ by 2023. Therefore, the NJ work location for this role will be temporarily based and the exact timing of the departmental move to Rahway, NJ will be communicated at a future date.
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.
Under the general direction of the Clinical Safety and Risk Management (CSRM) Therapeutic Area (TA) Lead and Vice President, Chief Safety Officer, the Executive Director for CSRM will be responsible for overall clinical risk management and safety surveillance of assigned investigational products. Additionally, the incumbent will provide senior safety leadership for assigned marketed products across our company’s portfolio of products. The Executive Director will drive delivery of safety input to clinical development of oncology assets. This includes all aspects of safety data evaluation, including assessing safety from a variety of sources, e.g. clinical trials, literature, and post-approval use.
Responsibilities for risk communication include ensuring completeness of safety information in company core safety documents. The successful candidate will be responsible for leading and driving safety strategy for the development of assigned products. They will collaborate with appropriate cross-functional company departments and the therapeutic area head to ensure efforts are aligned to meet global risk management strategies for the product portfolio. They will be responsible for leading all interactions regarding product safety issues with Research & Development (R&D) governance committees and regulatory agencies. This senior role works closely with CSRM Leadership to implement the evolving direction for the risk management and safety function of the department, as well as helping to develop and align processes to support departmental objectives. They will also manage a team of safety physicians and have an oversight role for their products.
Education:
+ Required: MD, DO, or equivalent
+ Preferred: Board Certification
Required Experience and Skills:
+ Minimum 3 years clinical practice experience following post-graduate medical training
+ Experience in drug development
+ Minimum 3 years of experience in clinical safety, pharmacovigilance and/or risk management
+ Minimum 5 years of employment in clinical development, drug safety or regulatory or equivalent
+ Demonstrated organizational leadership skills, preferably in the employment areas noted above.
+ Excellent communication, writing and analytic skills
Preferred Experience and Skills:
+ Experience managing people
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.
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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
Current Employees apply HERE (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)
Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)
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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088\EEOC\KnowYourRights\10\20.pdf)
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Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp\%20English\formattedESQA508c.pdf)
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.
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