Sr Specialist, Regulatory Digital Health Fellowship (Hiring Our Heroes)

We are excited to be a sponsor of Hiring our Heroes and proud to offer transitioning service members a unique opportunity to gain valuable professional experience through our 12-week fellowship program.

During your fellowship with our company, you will have the chance to collaborate with our Veterans Leadership Network and receive support from various stakeholders within the organization. To ensure your success, each fellow is paired with a buddy who will provide guidance, mentorship, and different perspectives. Additionally, you will have access to a career development advisor who will offer support and guidance in managing your career.

As a fellow, you will be part of a Cohort consisting of other transitioning service members. This will enable you to engage in weekly touchpoints, attend educational sessions, and receive direction from our Veteran Talent Program Lead throughout the Fellowship. Our primary objective is to provide you with mentoring, networking opportunities, and exposure to help facilitate a successful transition into a full-time position within our company.

With our generous military-friendly policies, we've received accolades from several organizations such as GI Jobs, Military Times EDGE, and Employer Support of the Guard and Reserve (ESGR). Consider a future with us and discover an employer who will foster your best work as you continue to strive for the well-being of others.

Who we are … 

We are known as Merck & Co., Inc., 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 integrity, knowledge, imagination, skill, and teamwork 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.

Overview:

The Regulatory Digital Health (RDH) department engages with enterprise leaders across the the company to support O.P.S. (Operations, Processes, and Strategic Execution) Policy Execution and the regulatory strategy of Digital Health tools (DHTs) and software medical devices (SaMD). In the preclinical space, RDH partners with functional leaders and teams within Digital Clinical Measures (DCM), Global Clinical Operations team (GCTO) and Business Development (BD) to assess the operational and regulatory capabilities of DHTs and SaMDs, identify regulatory risks and requirements. In the clinical arena, RDH works with key functional groups within Global Regulatory Affairs, GCTO and others to implement the regulatory strategy for the DHT/SaMD in global clinical trials. Finally, in the post-market commercial landscape, RDH works with Human Health (HH) to evaluate and support DHTs/SaMDs that support healthcare providers and our patients. These four pillars within Digital Health touch our patients, our drug development, and our execution excellence and help ensure we use the power of leading-edge science to save and improve lives worldwide.  

The O.P.S Policy Execution team is responsible for the coordination across O.P.S functions to effectively drive evaluation and implementation of policy into company processes, systems and roles in a timely manner according to relevance, importance, time sensitivity, and impact which is critical to maintaining regulatory compliance. This team also monitors a list of relevant industry topics that impact the relevant functional areas to improve awareness and influence of the evolving regulatory landscape. 

Your Fellowship Project

You will partner with RDH team members to optimize our trending and reporting of key performance indicators and metrics, enabling the team to better understand and communicate throughout the organization how Digital Health trends and evolving across the enterprise. In addition, this individual will actively support the team’s evaluation of HH digital solutions, ensuring timely and compliant evaluation of global solutions.

The fellowship intends to:

·       Gather feedback from the RDH and O.P.S. team the key strengths and weaknesses of the metrics gathering process.

·       Optimize and document the data gathering and visualization process.

·       Lead the RDH and O.P.S. team through the process and ensure leadership is well versed in the key insights from our metrics.

·       Develop an understanding of the key regulations and regulations to help evaluate Digital Health tools used to support Merck’s therapeutic assets.

·       Participate in team meetings to develop an understanding of the different skills and expertise of the cross functional members of the Regulatory Digital Health team.

·       Other duties as assigned.

Benefits of Fellowship

·       Mentoring & networking opportunities within and beyond RDH

·       Exposure to Senior level positions within the metrics process

·       Hands-on experience in the conduct and execution of Regulatory Digital Health assessments

·       Development of critical analysis and project management skills 

Experience/Skills We are Looking for:

·       Minimum: Bachelor’s Degree in Regulatory Affairs, Quality Assurance, Clinical Affairs, Pharmacovigilance, Biology, Engineering, Chemistry, or related science field or equivalent job experience. 

·       Must be willing to learn and grow their knowledge in the global regulatory requirements landscape for Drugs, Digital Health Technologies, and/or Medical Devices for both new product development for initial registration and maintenance of registrations. 

·       Broad awareness of Digital Health technologies and its application to drug development and marketed biopharmaceutical products. 

·       The ability to work with teams across the enterprise in the execution of tasks or process implementation.  

·       Possess excellent written communication skills for documenting internal strategy documents, internal communications, etc.  

·       Strong project management skills

·       Exhibit exceptional attention to detail during execution, review and assessment of tasks.  

·       Display flexibility and agility in adapting to changing situations, while maintaining, a high level of performance and delivering results.  

Primary Work Site/Schedule

·       On-site work locations: Upper Gwynedd, PA; Hybrid schedule

·       Monday-Thursday (Core hours: 9:00 am – 4:40 pm, flexible start and stop)

Requirement: Transitioning Service Member who is participating in the Hiring Our Heroes Corporate Fellowship Program

Fellowship Company Transition Opportunities: This Fellowship will be geared towards a Sr. Specialist position and does not align to a full time transition opportunity

Requisition ID:P-100835