Merck Associate Director - Regulatory Affairs (Drug Device Combination Products) in Rahway, New Jersey
Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.
This Associate Principal Scientist position is equivalent to an Associate Director position.
Under direction from Director/Executive Director, the Associate Principal Scientist is responsible for implementing Devices and Drug-Device Combinations (DDDC) regulatory strategies for our organization's in accordance with domestic and international regulations and guidance. The Associate Principal Scientist is responsible for the preparation and submission of combination product CMC sections for commercial or new products. The Associate Principal Scientist will assist in the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Sr. Scientist / Scientist in support of their assigned projects.
The Associate Principal Scientist responsibilities include but are not limited to :
Providing guidance as to best practices and expectations of medical devices used in clinical settings, including devices not necessarily being investigated or registered, but are utilized to gather/measure data.
Provide evaluations of regulatory state of affairs of any devices and combination products, for due diligence of potential suppliers, partners, or acquisitions.
Assess global device and combination product regulatory intelligence and assist in the development of device and combination product regulatory strategies.
Participate in CMC activities and teams related to device, and combination products
Anticipate device related regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
Assist in development of device validation protocols.
In depth knowledge of global device and combination product CMC guidelines regarding IND/CTA, 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.
Completion of detailed, global regulatory assessments according to existing global guidelines and policies and defined timelines.
Development and execution of detailed, global regulatory strategies for submission and approval of INDs, BLAs original NDA/MAA, agency background packages, post-approval submissions/variations, 510(K)s, CE marking and responses to health authority questions according to defined timelines.
Careful planning, tracking and communicating regarding submissions and approvals to support continued product supply.
Lead authoring of clear, concise and effective INDs, BLAs original NDA/MAA, agency background packages, post-approval submissions/variations, 510(K)s, CE marking according to defined timelines.
Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions.
Resolve project issues through collaboration with the team and escalation to the DDDC CMC leadership team as appropriate.
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.
Education Minimum Requirement:
- B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry.
Required Experience and Skills:
A minimum five (5) years of industry / regulatory experience in medical device research, development and/or manufacturing
Subject matter expertise in medical devices or combination product regulatory development and manufacturing
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 and ability to communicate complex issues in a succinct and logical manner.
Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
Demonstrated effective leadership, project management, communication, interpersonal and negotiating skills.
Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders
Strong knowledge and understanding of design controls process
Preferred Experience and Skills:
At least seven (7) years of experience in support of medical devices or combination products
Experience with IDE/IND/510(k) clearances/CE mark authorizations/NDA/BLA/postapproval experience in medical devices or combination products
Preferred fields of study include Microbiology, Virology, Molecular Biology, Engineering or Biochemistry
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., 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 .
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Requisition ID: R138681
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