Serialization Senior Consultant
Company: Clarkston Consulting
Location: Boston
Posted on: January 27, 2023
Job Description:
Do you want the opportunity to leverage your skills to make a
direct impact on the world's leading life sciences and consumer
products companies? Join Clarkston Consulting as a Serialization
Senior Consultant to help deliver creative business solutions to
our market-leading clients as a part of our team of experienced
professionals. We are looking for motivated, self-driven leaders
who are energized by team results and interested in joining a firm
that values its culture and people as its biggest strengths.
Together, we can help find the answers to our clients most
challenging business problems. What You'll Do Clarkston's
Serialization Senior Consultants advise clients on domestic and
global supply chain standards and compliance requirements from a
risk, value (ROI creation and retention), and integrity
perspective. As expert advisors, they provide regulatory analysis
and solution architecture recommendations for assisting clients in
achieving compliance with US Drug Supply Chain Security Act (DSCSA)
and global regulatory requirements. Candidates must have a thorough
understanding of the Life Sciences industry, the DSCSA Law, and FDA
Compliance requirements and of the Global regulatory landscape.
Effective candidates will also have a strong ability to understand
the clients' supply chain processes and create solutions for
addressing the current and future needs of the organization.
- Serve as lead for addressing the complex challenges facing our
clients and developing a blueprint for DSCSA and other global
compliance solutions.
- Serve as part of a team implementing business process
improvements and solutions that address the DSCSA and global
regulatory requirements for our clients.
- Engage with Clarkston's team to provide functional requirements
definition, guidance and design on track and trace solutions
functionality, reports, and custom interfaces.
- Observe and evaluate industry trends and benchmark operations
against industry standards.
- Provide guidance to systems analysts and client personnel
assigned to the projects.
- Assist with sales pursuits, including developing proposals and
participating in sales calls.
- Develop thought leadership on serialization and domestic and
global industry trends. How You'll Grow At Clarkston, we feel that
we provide the greatest value to our clients through a combination
of our industry expertise, business process knowledge, and
consulting excellence. Beyond your day-to-day responsibilities,
throughout your career at Clarkston you will:
- Have the support and mentorship of your Clarkston colleagues
and leaders
- Own your career - you'll be able to take charge of your career
journey with diverse opportunities to lead and expand your skillset
both at the client site and within the firm
- Have the opportunity to make a real and positive impact not
only the clients you work with, but on the firm as well Travel
RequirementTravel is an integral part of this role and is estimated
to average 30-50%. This may vary based upon client and project
needs. While travel is a requirement of the role, due to COVID-19
restrictions, all non-essential travel has been limited and any
on-site requests are subject to review. When not traveling,
consultants work from their home office. Relocation is not
required.What We're Looking For:An ideal Serialization Senior
Consultant candidate would have the following qualifications and
experience:
- Five (5) years of professional consulting experience in the
Life Sciences industry, with advanced knowledge of DSCSA, cGMP,
GMP, FDA regulations and 21 CFR Part 11,210, 211 and
820compliance
- At least one (1) full life cycle implementation of track and
trace solutions like SAP ATTP, TraceLink, RfExcel, Verify
Brands/Optel or others in a project lead capacity
- Deep understanding of systems development lifecycle and system
implementation methodologies with expert level configuration and
design skills
- Deep understanding of the global supply chain and manufacturing
process, tracking, and traceability
- Understanding of blockchain technology and how it may be used
in serialization
- Deep familiarity with serialization functional and technical
standards, e.g., GS1, EPCIS
- Knowledge of global serialization initiative, (i.e. EU FMD,
South Korea, etc.) and the associated criteria is preferred
- Excellent interpersonal, written, and oral communication skills
with a demonstrated ability to gain the confidence and respect of
client leadership
- Demonstrated ability to work autonomously and in a team
environment
- Meaningful client services orientation and accustomed to taking
an active role in executing engagements and project
plans/tasks
- Excellent analytical skills and the ability to present and
write at publication-quality level to communicate findings and
recommendations
- Minimum degree requirement: bachelor's degree in Business,
Management Information Systems, Engineering, Computer Science or an
equivalent discipline Our benefits include:
- Comprehensive Health and Wellness Benefits (Medical, Dental,
Vision, and more)
- 401k with company contributions
- Paid vacation, personal days, holidays, and sick leave
- Paid Parental Leave
- Life and Disability Insurance
- Company Equity or Stock Options
- Training and Professional Development investments Visit to
learn more about our culture, benefits, and opportunities. We hope
you'll join us! COVID-19 Vaccination StatementWhile Clarkston
Consulting has not mandated vaccination at this time, COVID-19
vaccinations are required in order to access Clarkston Consulting
facilities and those of many of our clients. With this in mind, all
prospective hires will be required to provide their vaccination
status.
Keywords: Clarkston Consulting, Boston , Serialization Senior Consultant, Professions , Boston, Massachusetts
Didn't find what you're looking for? Search again!
Loading more jobs...