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Provide regulatory and scientific expertise and leadership to shape regulatory CMC strategies for postapproval changes Develop and implement best practices based on current and emerging industry trends, and relevant Health Authority guidance and regulations Ensure high quality and on time regulatory submissions that align with company strategies and Health Authority requi
Posted 28 days ago
This physician's primary responsibility will be to advance the company's immune oncology program. Candidate in this position will be Mentored and supervised by a senior team member, who will provide guidance and opportunity for their professional development. Key responsibilities for the Medical Director/Senior Medical Director include Support/Lead medical monitoring acti
Posted 28 days ago
The Associate Director or Director of Biostatistics will support drug development activities and decision making encompassing Phase I IV studies. This includes guidance on designing studies, selecting appropriate and innovative statistical methods, analyses, interpretation, and reporting of study results. Duties and Responsibilities Work with a group of biostatisticians t
Posted 28 days ago
This role reports directly to the Associate Director of Information Security and will be responsible for a broad range of tasks including Information Security Third Party risk management as well as managing, monitoring and reporting on all aspects of the company's security tools and technologies. The role will require managing security activities such as security solution
Posted 28 days ago
s and programs of work E nsure compliance across all EHS regulatory and permit/ licensed requirements Partner with key functional stakeholders to instill collective accountability and embed a self sustaining culture of EHS excellence Actively sponsor the implementation and evolution of the company's behavioral risk program (CaRE) to achieve the highest levels of employee e
Posted 28 days ago
Drive and manage the creation, development, and implementation of HCP focused marketing strategies and plans, key messages, and promotional activities that increase brand awareness and accelerate profitable revenue growth Develop / refine product positioning and core messaging for VIVITROL Collaborate with Medical Affairs, Legal, and Regulatory in developing branded and n
Posted 28 days ago
A l kerme s, Inc. is the U.S. operating company of Alkermes p lc, a fu lly i n t egra t ed , g l oba l b i opharmaceu ti ca l compan y that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major the
Posted 28 days ago
of duties We are seeking a highly motivated candidate with hands on experience in developing small and large molecule assays and sample analysis . The successful candidate will support Discovery, Preclinical, and Clinical Development programs as representative on the bioanalytical team. He/she will also represent the PK/PD discipline on large molecule discovery project tea
Posted 28 days ago
This position will provide experienced, strategic legal counsel to various G&A and related business departments in the company, with a specific focus on supporting clients with drafting, reviewing, interpreting and negotiating a wide variety of contracts of differing complexity. Key responsibilities Provide full service strategic legal advice regarding contracting matters
Posted 28 days ago
Alkermes is seeking an experienced IT Associate Director for the Development Organizations. This individual will be responsible for leading a skilled IT team in implementing Development IT solutions across the Development space; including Analytical Development, Formulation Development, Pharmaceutical Chemistry, and Process Development. The individual will also lead the R
Posted 28 days ago
Alkermes is seeking a Vice President to lead our CNS Biology Department within Research. The successful applicant will join the Research Leadership team and report directly to SVP of Research. The CNS Biology group is responsible for all aspects of disease biology in our neuroscience projects. Our interest spans neurodegenerative, neurodevelopmental and neuropsychiatric i
Posted 28 days ago
Project support Responsible for coordination, logistics, tracking and administrative tasks in support of Clinical Development Operations and Global Clinical Services. Operational support Responsible for special projects supporting departmental operations. The preferred duration for this internship is 6 months. Duties and Responsibilities Supports and/or tracks access righ
Posted 28 days ago
include but are not limited to Collaborate within cross functional teams, specifically with Formulation and Analytical Development to execute development strategies that enable successful launch of Alkermes products Develop large molecule drug product unit operations (batch/continuous) with a focus on process understanding, identification of critical process parameters and
Posted 28 days ago
The QC Analyst I will be responsible for performing functions including environmental monitoring, utilities monitoring, and testing in a facility that manufactures sterile products and tablets in a GMP environment. Major Responsibilities Perform environmental monitoring in aseptic, classified, and controlled areas (routine, batch, quarterly EM). Direct support of the manu
Posted 29 days ago
The QC Analyst I will be responsible for performing functions including environmental monitoring, utilities monitoring, and testing in a facility that manufactures sterile products and tablets in a GMP environment. Major Responsibilities Perform environmental monitoring in aseptic, classified, and controlled areas (routine, batch, quarterly EM). Direct support of the manu
Posted 29 days ago
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