Senior Program Manager - Medical at EPAM Systems

| Greater NYC Area | Remote
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EPAM is a leading global provider of digital platform engineering and development services. We are committed to having a positive impact on our customers, our employees, and our communities. We embrace a dynamic and inclusive culture. Here you will collaborate with multi-national teams, contribute to a myriad of innovative projects that deliver the most creative and cutting-edge solutions, and have an opportunity to continuously learn and grow. No matter where you are located, you will join a dedicated, creative, and diverse community that will help you discover your fullest potential.
Description
We are looking for an experienced Program Manager to organize and coordinate medium to large-size programs. This position will include providing strategic guidance to teams and project managers in ways that promote transparency to all key stakeholders. Candidate should be a proven leader, have experience in managing staff of different disciplines in direct or matrix structure and produce results in a timely manner and be able to provide professional/SME guidance on Regulatory/Compliance topics (GxP, FDA, CE and other regulatory bodies).
Req. #254365647
WHAT YOU'LL DO
  • Lead cross-functional research and technology teams to achieve key program objectives within a portfolio
  • In collaboration with senior team members, you will assist in formulating and executing the strategy for advancing EPAM programs to successful completion
  • Ensure effective, accurate, appropriate and timely communication within cross functional teams to achieve key program objectives
  • Define and implement Program KPIs in a KPI-driven program delivery organization
  • Proactively identify issues and provide general guidance to resolve program and team challenges
  • Develop practical solutions to achieve program productivity and quality goals and objectives
  • Develop, maintain and update integrated project/program plans, and ensure alignment of these plans across functions and with team leadership
  • Maintains knowledge of current status, milestones, issues and key data for assigned programs and serve as the conduit of information and updates
  • Provide input and general guidance to the team for presentations and updates to management and outside collaborators where applicable
  • Provide updates on key issues and progress to Sr. Management
  • Identify opportunities for standardization of processes and working best practices as well as recommend a plan for implementation
  • Work with EPAM and client teams to track accountability of all programs and help drive EPAM's engagement
  • Partnering with the Delivery Management Center, you will be responsible for managing client expectations from delivery perspective
  • Provide support to the project team as a lead SME on Regulatory/Compliance aspects
  • Responsible for establishing and leading Regulatory Strategy for a chosen target market
  • Adopt the project targets and deliverables to fit into the Regulatory plan
  • Responsible for supporting the FDA submissions, communications and inspection process for the developed product
  • Ability to support and create client's continuous improvement efforts within the project boundaries
  • Experience with Establishment, Implementation and Improvements of Medical/HC/LS QMS

REQUIREMENTS
  • Minimum of five (5) years professional experience, including regulatory affairs, Medical/HC/LS compliance matters, quality systems, internal auditing, applicable scientific or technical functions and/or healthcare industry experience
  • 5 years of working knowledge of regulations and standards, including, but not limited to, U.S. FDA device QSR and cGMP regulations, EU medical device requirements, and ISO 13485 medical device standard
    • 21 CFR Part 820 - Medical Device Quality System Regulations (QSR)
    • 21 CFR Part 211 - Current Good Manufacturing Practice for Finished Pharmaceuticals (cGMP)
    • 21 CFR Section 1271.150 - Current Good Tissue Practice (cGTP)
    • 21 CFR Part 11 - Electronic Records, Electronic Signatures
    • ISO 13485: Medical devices - Quality management systems
    • EN ISO 11135-1:2007 - Sterilization of healthcare products - Ethylene oxide
    • EN ISO 11137-1:2006 - Sterilization of healthcare products - Radiation
  • Ability to motivate, train and develop the project team to ensure compliance with customers internal SOP's and global relevant rules and regulations
  • Can comfortably and effectively resolve difficult situations in a timely and appropriate manner
  • Experienced in working effectively on cross-functional teams; able to lead cross-functional team when required
  • Self-starter with demonstrated organizational, project management, time management and problem-solving skills is preferred
  • Demonstrated ability to balance multiple high priority responsibilities on-time and effectively
  • Strong interpersonal skills - ability to work closely with people at all levels within the organization and facilitate the implementation of corrective action; able to work effectively and professionally with external people including customers and government officials
  • Strong program and product management skills in a highly technical environment
  • Experience establishing and managing end-to-end Program or Project process while managing multiple programs in parallel
  • Experience working in pre-sales environment from solutioning to client communication highly desired
  • Knowledge of software development/Product lifecycle, methodologies (Agile, Kanban, Waterfall) and IT roles
  • Excellent business communication and time management skills required
  • Ideal candidate should have extensive experience in defining product strategy and roadmap

WHAT WE OFFER
  • Medical, Dental and Vision Insurance (Subsidized)
  • Health Savings Account
  • Flexible Spending Accounts (Healthcare, Dependent Care, Commuter)
  • Short-Term and Long-Term Disability (Company Provided)
  • Life and AD&D Insurance (Company Provided)
  • Employee Assistance Program
  • Unlimited access to LinkedIn learning solutions
  • Matched 401(k) Retirement Savings Plan
  • Paid Time Off
  • Legal Plan and Identity Theft Protection
  • Accident Insurance
  • Employee Discounts
  • Pet Insurance

ADDITIONAL
  • This position operates in a remote capacity, but you must live within driving distance to an EPAM office. Your recruiter will discuss specific details about work location during the initial interview process
  • Depending on the position, EPAM employees may need to work at a client worksite or an EPAM office. To protect employees and help communities fight the COVID-19 pandemic, vaccination is required to visit a EPAM office in the US, and many of our clients have similar policies in place. Due to this, a COVID-19 vaccination may be necessary and when applicable, specific details will be discussed during the interview process which may include providing proof of vaccination. For candidates with exceptional circumstances that prevent them from getting the COVID-19 vaccine, we will offer alternative reasonable accommodation, where possible, which should be coordinated by your recruiter and discussed directly with an HR Representative
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Technology we use

  • Engineering
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Location

Located just West of Madison Square Park, EPAM is surrounded by great lunch spots and easily accessible by New York and NJ public transportation.

An Insider's view of EPAM Systems

How would you describe the company’s work-life balance?

My manager ensures that I have a great work-life balance at EPAM. This is of particular importance to me being the mother of a 19-month-old. They allow me the flexibility to care for my child while providing me with a rewarding career path.

Regine

Senior Manager, Life Sciences Consulting

How has your career grown since starting at the company?

EPAM gave me a fresh start and a great opportunity. From the first day, I was given the support I needed from my mentors to feel that anything is possible. At EPAM, I had the rights tools, support and drive to know that I could really grow my career here.

Ariani

Data Scientist

How do your team's ideas influence the company's direction?

Our team is constantly looking for ways to improve our ability to deliver to the customer and ways to provide our people with a great work environment and career opportunities. Through involvement with different practices within the company, we provide meaningful feedback and ideas to enhance and better target our solutions to our customer needs.

Martin

VP, Technology Solutions

What makes someone successful on your team?

To be successful at EPAM and on my team, you have to be tenacious with a proclivity for pioneering into emerging areas and driving hyper-growth.

Broderick

Managing Principal, Health & Life Sciences Consulting

What are EPAM Systems Perks + Benefits

EPAM Systems Benefits Overview

EPAMers appreciate our flexible and casual work environment, excellent benefits and endless opportunities to thrive. In addition to health benefits, a 401(K) matching program and paid time off, EPAM offers the following perks:

- Competitive Salary & Bonus Program
- Career Development Opportunities
- Tech Community Meet-Ups & Hackathons
- Access to LinkedIn Learning Solutions
- Cutting-edge Internal Tools
- Volunteer & Mentoring Programs
- Travel & Relocation Opportunities
- Employee Discounts

Culture
Volunteer in local community
Partners with Nonprofits
Friends outside of work
Eat lunch together
Daily sync
Open door policy
Team owned deliverables
Team based strategic planning
Group brainstorming sessions
Pair programming
Open office floor plan
Diversity
Documented equal pay policy
Dedicated Diversity/Inclusion Staff
Highly diverse management team
Unconscious bias training
Diversity manifesto
Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Disability Insurance
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Pet Insurance
Wellness Programs
Retirement & Stock Options Benefits
401(K)
401(K) Matching
Performance Bonus
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Remote Work Program
Vacation & Time Off Benefits
Generous PTO
Paid Holidays
Paid Sick Days
Perks & Discounts
Casual Dress
Commuter Benefits
Company Outings
Stocked Kitchen
Relocation Assistance
Professional Development Benefits
Job Training & Conferences
Tuition Reimbursement
Cross functional training encouraged
Promote from within
Mentorship program
Time allotted for learning
Online course subscriptions available
Customized development tracks
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