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Results based on filters ( 117 jobs found )

Director, Validation

Alkermes
Wilmington, OH
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Director, Validation Overview Provide leadership for all validation ...
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Summary
About the job:
activities within Alkermes organization including clinical and commercial manufacturing support via facilities/equipment/filter/cleaning & manufacturing process validation, capital project support via commissioning and qualification, computer systems qualification, and oversite of entire validation program. Position includes management responsibilities for internal and contractual employees. This position description/summary reflects management’s assignment of essential functions; it does not prescribe or restrict the tasks...
Location:
Wilmington, OH
Job Type:
Full-Time
Permanent
Occupation:
Quality Control Systems Managers
Career Level / Education:
Bachelor's degree
Salary:
Six Figure Jobs (more than $100K)
From:
Ivy Exec
Certifications / Licenses:
N/A
Workkeys
Applied Math
N/A
Graphic Literacy
N/A
Workplace Documents
N/A
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Executive Medical Director, DSPV

Alkermes
Waltham, MA
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The Executive Medical Director serves as a senior member of the DSPV ...
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Summary
About the job:
leadership team, accountable for the management, mentoring and development of assigned benefit-risk management staff as well as serving as a global safety officer for assigned investigational and/or marketed products. Reporting to the Head of DSPV, the Executive Director will also serve in a visible role in providing safety leadership and advisement in several company-wide forums and initiatives. The successful candidate will have demonstrated prior career success as a product safety physician and managing/ developing...
Location:
Waltham, MA
Job Type:
Full-Time
Permanent
Occupation:
Clinical Research Coordinators
Career Level / Education:
Bachelor's degree
Salary:
Six Figure Jobs (more than $100K)
From:
Ivy Exec
Certifications / Licenses:
N/A
Workkeys
Applied Math
N/A
Graphic Literacy
N/A
Workplace Documents
N/A
apply
Detailed Job Information

Senior Director, Statistical Programming

Alkermes, Inc.
Waltham, MA
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External Description Str : In this leadership position, the Senior Director, ...
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Summary
About the job:
Statistical Programming will serve as the head of statistical programming who oversees all statistical programming activities to support Alkermes’ growing portfolio. This leader will provide guidance on statistical programming technical skills, selecting appropriate and innovative approaches to produce high quality deliverables for in-house and outsourced projects. This role will manage hiring, resource planning and setting strategic vision for the statistical programming group as well as assist on complex...
Location:
Waltham, MA
Job Type:
Full-Time
Permanent
Occupation:
Clinical Data Managers
Career Level / Education:
Bachelor's degree
Salary:
Six Figure Jobs (more than $100K)
From:
Alkermes, Inc.
Certifications / Licenses:
N/A
Workkeys
Applied Math
N/A
Graphic Literacy
N/A
Workplace Documents
N/A
apply
Detailed Job Information

Associate Director, Information Security-DLP

Alkermes, Inc.
Waltham, MA
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External Description Str : Associate Director of Information Security We are ...
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Summary
About the job:
seeking a highly motivated, hands-on Information Security leader with strong, broad security expertise and proven experience in Data Loss Prevention (DLP) and Data Security Posture Management (DSPM), to join our team as an Associate Director of Information Security . This is a senior technical role that combines strategic leadership with technical execution to protect sensitive data across complex environments. In addition, this role will also oversee the Information Security Third-Party Risk Management (TPRM)...
Location:
Waltham, MA
Job Type:
Full-Time
Permanent
Occupation:
Information Security Analysts
Career Level / Education:
Bachelor's degree
Salary:
Six Figure Jobs (more than $100K)
From:
Alkermes, Inc.
Certifications / Licenses:
Certified Information Security Manager
Distinguished Logistics Professional
Certified Information Systems Security Professional
Workkeys
Applied Math
N/A
Graphic Literacy
N/A
Workplace Documents
N/A
apply
Detailed Job Information

Associate Director, Information Security (Cloud and Emerging Technology)

Alkermes, Inc.
Waltham, MA
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External Description Str : We are seeking a highly motivated, experienced ...
Details
Summary
About the job:
hands-on Associate Director of Information Security (Cloud and Emerging Technology) to take a leadership role in shaping and executing the organizations security strategy in advanced technologies. Reporting to the Director of Information Security, this position will oversee a small team of security professionals and act as a trusted advisor across IT, and business units. This role will be responsible for developing, implementing, and enforcing security frameworks and guardrails for cloud environments (primarily AWS),...
Location:
Waltham, MA
Job Type:
Full-Time
Permanent
Occupation:
Information Security Engineers
Career Level / Education:
Bachelor's degree
Salary:
Six Figure Jobs (more than $100K)
From:
Alkermes, Inc.
Certifications / Licenses:
Cisco Certified Security Professional
Certified Information Security Manager
Distinguished Logistics Professional
Certified Information Systems Security Professional
Workkeys
Applied Math
N/A
Graphic Literacy
N/A
Workplace Documents
N/A
apply
Detailed Job Information

Associate Director, CMC Regulatory Affairs

Alkermes, Inc.
Waltham, MA
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External Description Str : Regulatory Affairs Chemistry, Manufacturing, and ...
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Summary
About the job:
Controls (CMC), plays a critical role in supporting a diverse portfolio of small molecule development programs and marketed products across multiple sites. Our team is driven by strategic excellence, collaborative spirit, and a commitment to delivering high-quality regulatory outcomes. We are seeking an experienced Associate Director, Regulatory Affairs CMC to serve as the Regulatory CMC Lead for a late-stage small molecule development program. This individual will be responsible for providing strategic regulatory...
Location:
Waltham, MA
Job Type:
Full-Time
Permanent
Occupation:
Regulatory Affairs Specialists
Career Level / Education:
Bachelor's degree
Salary:
Six Figure Jobs (more than $100K)
From:
Alkermes, Inc.
Certifications / Licenses:
Certified Management Consultant
Workkeys
Applied Math
N/A
Graphic Literacy
N/A
Workplace Documents
N/A
apply
Detailed Job Information

Associate Director, Competitive Intelligence

Alkermes, Inc.
Waltham, MA
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External Description Str : The Associate Director, Competitive Intelligence ...
Details
Summary
About the job:
(CI) will be part of a growing innovative team responsible for delivering actionable competitive insights to support strategic decision-making for both inline products and a late-stage pipeline asset. The Associate Director will partner closely with cross-functional teams, including Commercial, Medical, and R&D to reduce decision risk, and inform portfolio and product strategy. This role will be based in our Waltham office and work a Hybrid office schedule. Responsibilities: CI for Inline Products Monitor and analyze...
Location:
Waltham, MA
Job Type:
Full-Time
Permanent
Occupation:
Market Research Analysts and Marketing Specialists
Career Level / Education:
Bachelor's degree
Salary:
Six Figure Jobs (more than $100K)
From:
Alkermes, Inc.
Certifications / Licenses:
N/A
Workkeys
Applied Math
N/A
Graphic Literacy
N/A
Workplace Documents
N/A
apply
Detailed Job Information

Director, Health Eco and Outcomes Research

Alkermes, Inc.
Waltham, MA
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External Description Str : We are seeking a highly motivated and strategic ...
Details
Summary
About the job:
individual for a Director of Health Economics and Outcomes Research (HEOR) role at Alkermes. This is an exciting, visible, and highly collaborative opportunity where you will play a pivotal role in executing on evidence generation plans in support of Alkermes’ most advanced pipeline program in sleep-wake disorders. You will report to and support the Head of HEOR in the delivery of research activities and development of materials to support engagements with key stakeholders, including physicians, regulatory agencies,...
Location:
Waltham, MA
Job Type:
Full-Time
Permanent
Occupation:
Clinical Research Coordinators
Career Level / Education:
Bachelor's degree
Salary:
Six Figure Jobs (more than $100K)
From:
Alkermes, Inc.
Certifications / Licenses:
N/A
Workkeys
Applied Math
N/A
Graphic Literacy
N/A
Workplace Documents
N/A
apply
Detailed Job Information

Director, Regulatory Affairs, Labeling

Alkermes, Inc.
Waltham, MA
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External Description Str : Reporting to the Vice President, Regulatory ...
Details
Summary
About the job:
Affairs, Advertising Promotion & Labeling, the Director, Regulatory Affairs, Labeling will lead and facilitate the generation of new, and revision of, core labeling documents (Target Labeling, Company Core Data Sheet, US Prescribing Information, etc), in collaboration with cross-functional subject matter experts and Global Regulatory Leads (GRLs). The position requires management of multiple assigned products, including early and late-stage assets with differing levels of complexity. This position partners with other...
Location:
Waltham, MA
Job Type:
Full-Time
Permanent
Occupation:
Regulatory Affairs Specialists
Career Level / Education:
Bachelor's degree
Salary:
Six Figure Jobs (more than $100K)
From:
Alkermes, Inc.
Certifications / Licenses:
N/A
Workkeys
Applied Math
N/A
Graphic Literacy
N/A
Workplace Documents
N/A
apply
Detailed Job Information

Medical Director, Clinical Development (Neurology)

Alkermes, Inc.
Waltham, MA
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External Description Str : This is a high impact position with great ...
Details
Summary
About the job:
visibility across all levels of the Alkermes organization. This position will have critical responsibilities in the clinical department involved in the development of therapies for neurology and neuropsychiatric indications, including sleep disorders. Key trial related responsibilities include development of study protocols, medical review of clinical trial data and generation of clinical study reports. Additionally, the Medical Director will participate in internal strategy regarding future therapeutic priorities and...
Location:
Waltham, MA
Job Type:
Full-Time
Permanent
Occupation:
Clinical Research Coordinators
Career Level / Education:
Bachelor's degree
Salary:
Six Figure Jobs (more than $100K)
From:
Alkermes, Inc.
Certifications / Licenses:
Board Certified
Workkeys
Applied Math
N/A
Graphic Literacy
N/A
Workplace Documents
N/A
apply
Detailed Job Information
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