2820 The Empowerment Network jobs in Massachusetts
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Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug-Device Combinations Human Factors
Takeda Pharmaceutical
Boston, MA 02108
HybridEducation AssistanceHealth InsurancePaid Time OffRetirement Benefit
- BS/BA Degree in a Scientific, Pharmaceutical or Engineering Discipline, Advanced Degree Preferred.
- 10+ years of experience in a device and/or combination product role in pharmaceuticals and/or medical devices industry including experience in regulatory CMC; international experience is a plus.
- A minimum of 10 years of relevant industry experience (e.g., combination of pharmaceutical and medical devices).
- 2 years management of direct reports desired.
- Experience working on cross-functional teams including technical quality and commercial manufacturing and supply stakeholders, leading and influencing on regulatory positions, to set programs on course for regulatory success
- Proven expertise and experience in the area of Human Factors and allied fields for drug-device combinations
- Experience supporting interactions with FDA, EMA, Notified Bodies and other global health authorities specifically related to Combination Products and Device submissions (e.g., IND, CTA, IMPD, BLA, MAA, NDA, 510(k), Notified Body Opinions, Technical File submissions, global post approval submissions, etc.) is strongly preferred, including expertise with proposing science-based, data-driven regulatory positions and conducting negotiations with regulators
- Demonstrates emerging leadership, problem-solving ability, flexibility and teamwork
- Exercise good judgement in elevating and communicating actual or potential issues to line management
- Excellent written and oral communication skills are required, with cross-organization stakeholder engagement
- Ability to self-direct within a project team and properly manage tasks and work expectations, lead, be influential and effective, collaborate with GRA Liaisons, GRA CMC Leads and other regulatory functions, driving drug-device combination strategy
- Active participation in industry forums is expected
- Able to deal with issues of critical importance, provide regulatory advice and make reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance, with an emphasis on Design Control issues.
- Willingness to travel to various meetings or events, including overnight trips. Some international travel may be required.
- Requires approximately 10% travel
New, Posted 1 day ago
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Data Entry Clerk - Remote Work From Home (Part-Time / Full-Time)
Apex Focus Group
Boston, MA 02298
$750/wk
RemoteNo Experience
New, Posted 1 day ago
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Network Services Manager - Audio Visual, Event Technology
Pinnacle Live
Boston, MA 02108
New, Posted 6 hours ago
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Amazon Customer Service - Work From Home $16-$24/hr
Amazon
Fitchburg, MA 01420
$16-$24/hr
RemoteNo Experience
New, Posted just now
Information Technology Professional
US Navy
Waltham, MA 02453
New, Posted 1 day ago
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Network Engineer, Signal Source Solutions
Communication Technology Services (CTS)
Marlborough, MA 01752
OnsiteHealth InsurancePaid Time OffRetirement Benefit
- Experience working as part of an in-building coverage team at AT&T; Verizon or T-Mobile, either as an employee of one of these companies or as a key supplier to these companies is required.
- Proven track record in designing and deploying in-building cellular networks required.
- Certifications or relevant work experience in IP networking, VPN configurations, and firewall deployments is required
- Experience specifically with Fortinet® is preferred
- Proficiency with the iBwave® is required
- BS/BA degree, preferably in Engineering or equivalent experience
New, Posted 3 hours ago
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Mobile Trailer Technician - $38-$45/hr. - Weekly Pay Sign-On Bonus Quarterly Bonuses
TEN Transportation Equipment Network
Randolph, MA 02368
$38-$45/hr
New, Posted 1 day ago
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Network Engineer, Signal Source Solutions
Communication Technology Services
Marlborough, MA 01752
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AI Development & Agent Ops — Principal Software Engineer
Dell
Hopkinton, MA 01748
Paid Relocation to Hopkinton, MA
Remote
New, Posted 21 hours ago
Compliance and Training Specialist
Pathway to Possible
Newton, MA 02458
Easy Apply
Production Operations
Adecco
Waltham, MA 02453
$28/hr
OnsiteHealth InsurancePaid Time OffRetirement Benefit
- High School Diploma or GED
- Minimum of 1 year customer service-related experience preferred and at least 2 years related shipping experience preferred
- Experience with shipping goods both domestic and international, as well as familiarity with consolidating shipments
- Knowledge and experience processing shipments using various shipping software and systems such as UPS WorldShip, Fed-Ex Ship Manager, and DHL Easy Ship Professional
- Experience with (A.E.S.) Automated Export System - Experience with generating shipping documentation such as airway bills, (S.E.D.'s) Shippers Export Declarations and (S.L.I.'s) Shippers Letter of Instruction for domestic and international shipments
What companies are hiring The Empowerment Network jobs in Massachusetts?
- Takeda Pharmaceutical
- Apex Focus Group
- Pinnacle Live
- Amazon
- US Navy
- Communication Technology Services (CTS)
- TEN Transportation Equipment Network
- Communication Technology Services
- Dell
- Pathway to Possible
- Adecco
- Takeda Pharmaceutical
- Apex Focus Group
- Pinnacle Live
- Amazon
- US Navy
- Communication Technology Services (CTS)
- TEN Transportation Equipment Network
- Communication Technology Services
- Dell
- Pathway to Possible
- Adecco
What is the hourly salary range for The Empowerment Network jobs in Massachusetts?
The hourly salary range is $16 - $45.
The hourly salary range is $16 - $45.
