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ASSOCIATE DIRECTOR, REGULATORY STRATEGY

Sarepta Therapeutics
Cambridge, MA
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Co-lead the strategy and implementation of global regulatory strategies for ...
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Summary
About the job:
In Vitro Diagnostics (IVD)/Companion Diagnostics (CDx) to support business objectives. Act as the interface with multiple internal and external stakeholders, including partners. Works as Global Regulatory Leads (GRLs) for assigned projects. Positively contributes to the regulatory probability of success for clinical and commercial therapeutic programs. Develops and delivers on fit for purpose high quality documentation (e.g., IDEs, IVDR documents, PMAs, reports, and correspondences) to support successful global Health...
Location:
Cambridge, MA
Job Type:
Full-Time
Permanent
Occupation:
Regulatory Affairs Managers
Career Level / Education:
High school diploma or equivalent
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
5
apply
Detailed Job Information

Global Market Access Contractor

Sarepta Therapeutics
Cambridge, MA
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The Global Market Access Contractor is responsible for the development of ...
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Summary
About the job:
global market access strategies for Sarepta’s assets in alignment with the broader International Business Unit goals and priorities. This position requires proactive participation in cross-functional teams, demonstration of strong leadership and strategic thinking and ability to manage multiple projects. In collaboration with the broader International Business Unit, the global market access contractor proactively monitors external market access / evidence generation requirements and drives development of market access...
Location:
Cambridge, MA
Job Type:
Full-Time
Temporary
Occupation:
Public Relations Managers
Career Level / Education:
Bachelor's degree
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
4
apply
Detailed Job Information

IT Support Specialist I

SareptaTherapeutics
Cambridge, MA
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Job Description The Position: Level I Specialist primary duties include Tier ...
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Summary
About the job:
1 technical support, including software/hardware installation, troubleshooting, hardware break/fix, VoIP phone support and asset management. Primary Responsibilities Include: * Provide Tier 1 technical assistance for computer hardware, software systems, and printers/copiers * Respond to inquiries via email, phone, walk-up or ticketing system * Document all support incidents via our Help Desk Ticketing system and close tickets once issues have been resolved * Appropriately label and code all tickets * Setup and...
Location:
Cambridge, MA
Job Type:
Full-Time
Permanent
Occupation:
Computer User Support Specialists
Career Level / Education:
Associate's degree
Salary:
Upper Middle Income Jobs ($50K-$79K)
Certifications / Licenses:
Microsoft Certified Desktop Support Technician
CompTIA A+
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
4
apply
Detailed Job Information

Sr. Statistical Programmer

SareptaTherapeutics
Cambridge, MA
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Job Description The Position: Reporting into Statistical Programming ...
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Summary
About the job:
Department, the incumbent will be responsible for providing hands-on programming support and technical guidance on clinical trials and regulatory submissions. This individual will participate in the design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data for individual studies, and will review or validate statistical deliverables of vendors. Responsibilities: * Effectively design and code SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH...
Location:
Cambridge, MA
Job Type:
Full-Time
Permanent
Occupation:
Computer Programmers
Career Level / Education:
Bachelor's degree
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
5
Graphic Literacy
5
Workplace Documents
5
apply
Detailed Job Information

Manager, Systems Analyst R&D Systems

SareptaTherapeutics
Cambridge, MA
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Job Description The Position: Sarepta Therapeutics is looking for an ...
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Summary
About the job:
energetic and resourceful, Senior/R&D Systems Analyst who will be responsible for the portfolio of current and new applications used by Regulatory, Quality, Clinical, Data Management, etc. Under general direction, this individual administrates, supports, and maintains applications software and systems. This includes performing administrative and management tasks to maintain application operation, installing new systems, developing reports, supporting ancillary software, and maintaining system compliance, security, and...
Location:
Cambridge, MA
Job Type:
Full-Time
Permanent
Occupation:
Computer Systems Analysts
Career Level / Education:
Bachelor's degree
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
4
apply
Detailed Job Information

Principal Statistical Programmer, Statistical Innovation

SareptaTherapeutics
Cambridge, MA
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Job Description The Position: Reporting to Statistical Programming Lead for ...
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Summary
About the job:
Statistical Innovation, the incumbent will be responsible for providing hands-on programming support and technical guidance on statistical innovation activities. This individual will partner with other members of the Statistical Innovation team in the design, development and execution of innovation initiatives to accelerate clinical development. Responsibilities: * Partner with biostatistician(s) of the Statistical Innovation team to deliver programming solutions to enable innovative statistical designs and analyses...
Location:
Cambridge, MA
Job Type:
Full-Time
Permanent
Occupation:
Computer Programmers
Career Level / Education:
Bachelor's degree
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
5
Graphic Literacy
5
Workplace Documents
5
apply
Detailed Job Information

Principal Statistical Programmer

SareptaTherapeutics
Cambridge, MA
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Job Description The Position: Reporting into Statistical Programming ...
Details
Summary
About the job:
Department, the incumbent will be responsible for providing hands-on programming support and technical guidance on clinical project teams. This individual will participate in the design, development, and quality control process for SAS programs used to access, extract, transform, review, analyze, and submit clinical data for individual studies. Responsibilities: * Effectively design and code SAS programs using BASE/SAS, SAS/STAT, SAS/GRAPH and SAS MACROS for assigned clinical project(s).Produce and deliver CDISC and...
Location:
Cambridge, MA
Job Type:
Full-Time
Permanent
Occupation:
Computer Programmers
Career Level / Education:
Bachelor's degree
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
5
Graphic Literacy
5
Workplace Documents
5
apply
Detailed Job Information

Senior IT Systems Analyst - Supply Chain

SareptaTherapeutics
Cambridge, MA
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Job Description The Position: Sarepta Therapeutics is looking for an ...
Details
Summary
About the job:
energetic and resourceful Senior IT Systems Supply Chain Analyst who will be responsible for the portfolio of applications utilized by the Supply Chain Management (SCM) team. As an IT SCM Analyst, you will be responsible for the definition, development and implementation of best practices in SCM, and serve as the first point of contact for the user community supporting issue validation and scoping. Under general direction, this individual administrates, supports, and maintains applications software and systems, and...
Location:
Cambridge, MA
Job Type:
Full-Time
Permanent
Occupation:
Computer Systems Analysts
Career Level / Education:
Bachelor's degree
Salary:
Six Figure Jobs (more than $100K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
4
apply
Detailed Job Information

Senior IT Systems Analyst - Supply Chain

SareptaTherapeutics
Cambridge, MA
Actions
Apply
Save to My Profile
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Job Description The Position: Sarepta Therapeutics is looking for an ...
Details
Summary
About the job:
energetic and resourceful Senior IT Systems Supply Chain Analyst who will be responsible for the portfolio of applications utilized by the Supply Chain Management (SCM) team. As an IT SCM Analyst, you will be responsible for the definition, development and implementation of best practices in SCM, and serve as the first point of contact for the user community supporting issue validation and scoping. Under general direction, this individual administrates, supports, and maintains applications software and systems, and...
Location:
Cambridge, MA
Job Type:
Full-Time
Permanent
Occupation:
N/A
Career Level / Education:
Bachelor's degree
Salary:
High Income Jobs ($80K-$99K)
Certifications / Licenses:
N/A
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
4
apply
Detailed Job Information

IT Support Specialist II

SareptaTherapeutics
Cambridge, MA
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Job Description The Position: Level II Specialist primary duties include ...
Details
Summary
About the job:
Tier 1 and Tier 2 technical support, including software/hardware installation, troubleshooting, hardware break/fix, VoIP phone support, technical documentation, asset management and account management. This role acts as the second level of support to end users by handling service requests that have been escalated by lower tiers. Primary Responsibilities Include: * Provide Tier 1 and Tier 2 technical assistance for computer hardware, software systems, and printers/copiers * Respond to inquiries via email, phone, walk-up...
Location:
Cambridge, MA
Job Type:
Full-Time
Permanent
Occupation:
Computer User Support Specialists
Career Level / Education:
Associate's degree
Salary:
Upper Middle Income Jobs ($50K-$79K)
Certifications / Licenses:
Microsoft Certified Desktop Support Technician
CompTIA A+
Workkeys
Applied Math
4
Graphic Literacy
4
Workplace Documents
4
apply
Detailed Job Information
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