The Senior Scientist Regulatory CMC Combination Products role is equivalent to the Senior Scientist in Devices and Drug Device Combinations (DDDC) CMC. Reporting to the Associate Director/Director/Executive Director, the Senior Scientist in DDDC CMC is responsible to support CMC regulatory activities for our products in accordance with global regulations and guidelines and is responsible for technical content input and coordination of CMC submissions for all assigned activities. Product responsibilities may be in the small molecules, biologics or vaccines portfolio, and could be in the development or the marketed product phase of a drug product life cycle.
Primary responsibilities include, but are not limited to:
Provide scientific input into DDDC regulatory strategies by ensuring robust assessment of scientific content and critical evaluation of supporting regulatory documentation to confirm acceptability and identification of potential risks.
Support the CMC Product Team on assigned products and be accountable for the delivery of all assigned regulatory activities.
Support technical content writing and review in CMC documentation including INDs, BLAs original NDA/MAA, agency background packages, post-approval submissions/variations, 510(K)s, CE marking and responses to health authority questions per established business processes and systems.
Support device design control activities and documentation reviews
Develop an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval, product launch, and maintenance of market supply of our human medicinal products worldwide.
Conduct all activities with an unwavering focus on compliance, including staying current on all training.
Participation in early and late development programs, as well as departmental and cross-functional efforts to improve combination product CMC content or processes may also be required, as needed.
Carry out all assignments to the standards of efficiency, innovation, accuracy and safety in accordance with company and regulatory requirements.
Additional activities may be assigned by the supervisor.
Minimum required education:
B.S. in a biological science, engineering, or a related field (advanced degree preferred).
Fields of study include Pharmacy, Chemical Engineering, Biomedical Engineering, Biology, Microbiology, or Biochemistry
Required experience and skills:
At least two (2) years of experience (including internships), including regulatory affairs CMC or biological/pharmaceutical/medical device research and development, manufacturing, or testing
Demonstrated sound understanding of related fields (e.g., manufacturing, process development, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly, and conclusions are adequately supported by data.
Demonstrated superior oral and written communication skills in multicultural settings.
Preferred Experience and Skills:
Two (2) years of experience in support of drug-device combination products
Experience with IDE/IND/510(k) clearances/CE mark authorizations/NDA/BLA/post-approval experience in medical devices or combination products
Demonstrated ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data.
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.
Current Employees apply HERE
Current Contingent Workers apply HERE
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:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
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 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: $96,700.00 - $164,500.00
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
Relocation: No relocation
VISA Sponsorship: No
Travel Requirements: 10%
Flexible Work Arrangements: Hybrid
Shift: 1st - Day
Valid Driving License: Yes
Hazardous Material(s): no
Number of Openings: 1
To apply please click on APPLY TO THIS POSITION
Job Post Date: 12/14/22
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