Technical Lead, Clinical Systems IT
Company: Ultragenyx Pharmaceuticals
Location: Somerville
Posted on: June 16, 2022
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Job Description:
Why Join Us?Be a hero for our rare disease patientsAt
Ultragenyx, we fundamentally believe that taking real impactful
action to care for the needs of patients and our people is always
the right thing to do. -To achieve this goal, our vision is to lead
the future of rare disease medicine. For us, this means going where
other biopharma companies won't go - challenging the status quo and
creating a new model that advances our field so more patients and
caregivers can benefit from life-changing treatments. We do this by
following the science, applying a novel rapid development approach,
making innovative medicines at fair and reasonable prices, and
creating a collaborative ecosystem to reach patients in ways that
are most meaningful for them. -Our commitment and care for patients
extends to our people, so culture is an essential cornerstone for
Ultragenyx. We remain continuously focused on creating a supportive
and inclusive environment of profound learning and growth - so
employees can thrive in all areas of their lives, in and outside of
work. -Ultimately, we want to be an organization where we would be
proud for our family, friends and children to work.If you want to
have a meaningful impact, do the best work of your career, and grow
a lot, both professionally and -personally, come join our team.
During the COVID-19 pandemic, we are committed to the health and
safety of our employees and prospective employees, which means at
this time our interview processes may include virtual discussions,
interviews, and onboarding. Please note that compliance with local
regulations and safety protocols is a condition of employment at
Ultragenyx. Elements of safety protocols may include, but are not
limited to: work from home requirements, regular or symptom-based
covid testing, providing valid evidence of vaccination, mask
wearing, and physical distancing.US based roles: Full vaccination
against COVID-19 is a condition of employment at Ultragenyx. This
requirement applies to almost all roles at Ultragenyx based in the
U.S., with very limited exceptions. If you are unable to receive a
COVID-19 vaccine due to a disability, serious medical condition, or
because it would violate your sincerely held religious belief, you
will have an opportunity to request a reasonable accommodation. -
Roles based outside the US: - If the role requires travel to the US
or another country that requires evidence of covid vaccination for
entry, candidates and employees will be required follow the local
regulations and corporate policy regarding vaccination evidence
submission.Position Summary:ultrafocused - Work together to
fearlessly uncover new possibilitiesThe IT Analyst II will serve as
the Technical Lead for Clinical systems, playing a key role in
deployment, maintenance and enhancement of Information Technology
(IT) Research and Development (R&D) systems for Global
Development Organization (GDO) and Regulatory Operations
departments. - The ideal candidate will be experienced in Release
Management, Production Support, and system support of hosted and
Saas systems. As Clinical System Owner for, this position ensures
both business and technical are appropriately translated into
technical solutions and the systems are functioning per
requirements. Work Model:Flex: can complete work from home during
the pandemic; once return to the office 2-3 days in office to be
expected and established with manager.Responsibilities: Serve as IT
Technical Lead, supporting cross-functional stakeholders from
Global Development Organization (GDO) and Regulatory Operations
departmentsProvide technical oversight, support, and expertise for
managing day-to-day activities including implementation,
maintenance, enhancements and support all systemsOwn Clinical
R&D systems' incident management, problem management, and
performance monitoringLead Maintenance and Enhancement (M&E)
process, defining M&E requests from business, assessment impact
and prioritization, determining expected go-live date and preceding
milestones, creating release plan, owning IT Change Request, and
driving the implementation processAnalyze the impact of changes to
assigned GxP and non-GxP IT systems Provide technical oversight on
IT projects and initiatives, including vendor selecting, -systems
implementation, upgrades, defect fixes and enhancementsResponsible
for the incident and problem management processes for Functional
Departments'platforms, systems, applications, and
servicesParticipate in contract reviews, service level agreement
(SLA) negotiations and system/service reviews with multiple IT
vendorsWork with vendors to perform requirements walkthrough,
technical reviews, testing in Production and non-Production
environmentsCollaborate with IT and functional counterparts to
respond flexibly and adaptively to the system needs of the business
users, with a focus on continuous improvementPerform all activities
in compliance with relevant requirements/standards and controls
(e.g., GxP,HIPAA, GDPR, CCPA)Requirements: Bachelor's degree in
Information Technology, Computer Systems, Information Systems or
related field from a 4-year accredited institution4+ years of
relevant experience working with IT R&D systems. Experience
with one or more of the following systems preferred: eTMF, CTMS,
IRT/IxRS, eDiary, Wearables, eConsent, Publishing, RIM, etc)Ability
to lead cross-functional teams and change initiatives through
implementation with minimal oversight Experience as a system owner
preferredExperience in pharmaceutical or medical device industry
preferredStrong knowledge of GxP systems and their
requirementsExcellent analytical skills required for requirements
analysis and troubleshooting/triaging of issues Ability to
effectively document/communicate business requirements to system
vendorsExperience with testing applications based on requirements
needed Excellent verbal and written communications skillsGood
organization skills, ability to manage multiple tasksHighly
self-motivated and adopts a results -driven approach#LI-NJ1Full
Time employees across the globe enjoy a range of benefits,
including, but not limited to: - - - - - - - - - Generous vacation
time and public holidays observed by the company - - - - - - - - -
Volunteer days - - - - - - - - - Long term incentive and Employee
stock purchase plans or equivalent offerings - - - - - - - - -
Employee wellbeing benefits - - - - - - - - - Fitness reimbursement
- - - - - - - - - Tuition sponsoring - - - - - - - - - Professional
development plans* Benefits vary by region and countryUltragenyx
Pharmaceutical is an equal opportunity employer & prohibits
unlawful discrimination based on race, color, religion, gender,
sexual orientation, gender identity/expression, national
origin/ancestry, age, disability, marital and veteran status.
Reasonable accommodation will be provided for qualified individuals
with disabilities and for qualified disabled veterans in job
application procedures, as required by applicable law. If you have
any difficulty using our online application system and need an
accommodation due to a disability, you may contact -Talent
Acquisition -by calling: -(415) 483-8800 -or by -emailing -us at
-talentacquisition@ultragenyx.com. For electronic email and mail
inquiries, please include a description of your requested
accommodation, your name and contact information.See our -CCPA
Employee and Applicant Privacy Notice.See our -Privacy Policy.Note
to External Recruiters: All candidate activity and open positions
are managed strictly through our Human Resources Department. Our
Human Resources Department kindly requests that recruiters not
contact employees/hiring managers directly in an attempt to solicit
business and present candidates. Please note that failure to comply
with this request will be a factor in determining a professional
relationship with our organization. Submission of unsolicited
resumes prior to an agreement set in place between the Human
Resources Department and the recruiting agency will not create any
implied obligation. -Inquiries on developing a recruiting
relationship with us, may be directed to:
-talentacquisition@ultragenyx.com.Brisbane, CA, Novato, CA, or
Cambridge, MA /Ultragenyx - IT R&D /Full-time
Keywords: Ultragenyx Pharmaceuticals, Somerville , Technical Lead, Clinical Systems IT, Healthcare , Somerville, Massachusetts
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