Scientist, Devices and Drug Device Combinations CMC

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Location :
Kenilworth, New Jersey

Expiry Date :
Wed, 07 Apr 2021 23:59:59 GMT

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Scientist, Devices and Drug-Device Combinations CMC Job Description Our 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. The Scientist in Devices and Drug-Device Combinations (DDDC) CMC (Chemistry, Manufacturing, and Controls) is expected to support DDDC CMC regulatory activities for our products in accordance with global regulations and guidelines and isresponsible for technical content input and coordination of CMC submissions for all assigned activities. Product assignments 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 tasks include, but are not limited to: + Provide scientific input into DDDC regulatory strategy by ensuring a robust assessment of scientific content and critical evaluation of supporting regulatory documentation to confirm acceptability and identification of potential risks. + Partner with the CMC Product Team on assigned products and be accountable for the delivery of all assigned regulatory activities. + Conduct technical content writing and review in CMC documentation including Investigational New Drug application / Clinical Trial Application (IND/CTA), original New Drug Application / Marketing Authorization Application (NDA/MAA), agency background packages and post-approval submissions/variations per established business processes and systems. + Identify, convey and escalate potential issues to Regulatory CMC Product Lead + Develop an understanding of regulatory affairs and apply it to the benefit of the company to ensure approval, product launch, and maintenance of the market supply of our human medicinal products worldwide. + Conduct all activities with an unwavering focus on compliance, including staying current on all training. + Carry out all assignments to the standards of efficiency, innovation, accuracy and safety in accordance with company and regulatory requirements. + Additional activities as assigned by the supervisor. Technical Skills: + Background in reviewing scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data. + Demonstrated oral and written communication skills and the ability to convey issues in a succinct and logical manner. + Demonstrated application of related fields (e.g., manufacturing, analytical, quality assurance). Leadership Skills: + Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders. + Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. + Demonstrated effective leadership, communication, and interactive skills. Education: + B.S. in biological sciences, engineering, or a related field (advanced degree preferred) + Fields of study include Pharmacy, Chemical Engineering, Biomedical Engineering, Biology, Microbiology, or Biochemistry Required: + Minimum of 1 year relevant experience (including internships), including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields for candidates with a Bachelor’s or Master’s degree. This requirement is waived for candidates with a Ph.D. Preferred: + Ability to critically review detailed DDDC scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data. + Demonstrate scientific curiosity, exemplified by a passion to continue to learn and by proactively identifying areas of self-development and growth . + Technical leadership skills, as well as knowledge of related chemical and pharmaceutical operations (e.g., drug substance or drug product manufacturing, process development, analytical, quality assurance). + Ability to develop innovative and imaginative approaches to problem-solving and the ability to flexibly respond to changing priorities. + Possess superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities, and work well under pressure to be successful in this role. + Possess excellent verbal and written communication, presentation, and listening skills. We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we ‘follow the science’ and that great medicines can make a significant impact to our world. And 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., Kenilworth, 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 … In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth . INVENT. IMPACT. INSPIRE. CDN2021 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. US and Puerto Rico Residents Only: If you need an accommodation for the application process please email us at For more information about personal rights under Equal Employment Opportunity, visit: EEOC Poster ( EEOC GINA Supplement OFCCP EEO Supplement ( OFCCP Pay Transparency Rule We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations. Search Firm Representatives Please Read Carefully 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. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Specified Shift: 1st – Day Valid Driving License: Hazardous Material(s): Number of Openings: 2 Requisition ID: R89657