33 direct support professional jobs found

Alkermes, Inc. We are seeking an individual who is talented, motivated, and passionate about science to join our Regulatory Strategy team. As Associate Director of Regulatory Affairs, the successful candidate will play an important role in guiding new products into the clinic and setting the stage for registration. The individual in this role will provide strategic and tactical advice to teams to achieve support the development and maintenance of programs, while ensuring compliance with applicable regulatory requirements. The ideal candidate will have a strong scientific background, and be able to leverage their experience to provide leadership within the department and across R&D. This role reports to the Senior Director, Head of Orexin Regulatory Strategy. Responsibilities Contribute to development of robust, global regulatory strategies for assigned projects. Accountable for adapting and maintaining the regulatory strategy as needed Develop submission plans and...

The Nature Conservancy What We Can Achieve Together: The Senior Policy Advisor, Freshwater leads and implements The Nature Conservancy's (TNC's) federal freshwater policy strategies in service of TNC's 2030 goals. They work primarily with U.S. federal agencies, Congress, and partners to develop, modify and advance strategies to shape water policy in the United States. The successful candidate must reside in the Washington, D.C. metropolitan area. Reporting to the US Federal Water Policy Team Lead on the North America Policy and Government Relations team, the Senior Policy Advisor, Freshwater furthers the work of The Nature Conservancy and its conservation partners through direct interaction with U.S. government agencies and Congress focusing on policy, practice, and funding initiatives that provide conservation opportunities and/or impact conservation and restoration of freshwater throughout America. They serve as a leader for TNC in developing, analyzing and...

Merck Job Description Join Us in Shaping the Future of Animal Health Our Animal Health Division is investing $895 million in expanding our manufacturing and research & development facilities in De Soto, Kansas - the state's largest economic development project to date. As a Senior Specialist, Bioprocess Engineer , you will be part of a world-class team at our Center of Excellence in the Animal Health Corridor, contributing directly to the production of veterinary products that improve animal health and welfare globally. The Senior Specialist in Bioprocess Engineering team will act as a key technical expert for vaccine manufacturing technology transfers within the region. This individual contributor will lead end-to-end tech transfer of vaccine processes, ensuring robust, compliant, and efficient implementation at receiving sites. The role is responsible for structured knowledge management, proactive technical risk assessment and mitigation ahead of...

Merck Job Description Join Us in Shaping the Future of Animal Health Our Animal Health Division is investing $895 million in expanding our manufacturing and research & development facilities in De Soto, Kansas - the state's largest economic development project to date. As a Senior Specialist, Bioprocess Engineer , you will be part of a world-class team at our Center of Excellence in the Animal Health Corridor, contributing directly to the production of veterinary products that improve animal health and welfare globally. The Senior Specialist in Bioprocess Engineering team will act as a key technical expert for vaccine manufacturing technology transfers within the region. This individual contributor will lead end-to-end tech transfer of vaccine processes, ensuring robust, compliant, and efficient implementation at receiving sites. The role is responsible for structured knowledge management, proactive technical risk assessment and mitigation ahead of...

University of Michigan How to Apply A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position. Job Summary This position may independently provide study coordination for simple and moderately complex clinical research studies. As a member of a coordination team, this position may help support a portfolio of projects with varying levels of complexity. Mastery of all job duties from the CRC-Assistant position on the Michigan Medicine CRC Career Ladder is required. This position will serve as a Clinical Research Coordinator in the Pediatric Hematology/Oncology division, providing administrative study coordination and data entry support to faculty and research teams for the University of Michigan CS Mott Children's Hospital. Our program is renowned for our expertise in...

Wisconsin Economic Development Corporation Wisconsin Economic Development Corporation Position Description Position Title: Legislative Policy Analyst Department: Policy and Program Development Reports to: Director of Policy Position(s) Supervised: N/A FLSA Status: Exempt Position Summary The Legislative Policy Analyst is responsible for collecting, analyzing, and communicating legislative policy information to WEDC staff and stakeholders to achieve policy objectives and strategic initiatives. In support of these duties, the Legislative Policy Analyst provides government relations services to legislative offices, the Governor's office and the business community; establishes and maintains relationships with policymakers, state agencies and stakeholder associations; and assists in the development of policy recommendations. The Legislative Policy Analyst also serves as a subject matter expert by developing policy reports, briefs, and...

MathWorks Summary MathWorks has a hybrid work model that enables staff members to split their time between office and home. The hybrid model provides the advantage of having both in-person time with colleagues and flexible at-home life optimizations. Learn More: https://www.mathworks.com/company/jobs/resources/applying-and-interviewing.html#onboarding. MATLAB enables biologists worldwide to accelerate the pace of discovery in areas ranging from microscopy, biochemistry, cell biology, immunology, genetics and more, through applications for algorithm development, data analysis, statistics, visualization, numeric computation, high performance computing, and application deployment. If you have experience with MATLAB and are passionate about driving its adoption and usage in biological sciences, this is the role for you. As the Biological Sciences Market Development Manager, you will deploy your knowledge of MATLAB and the industry to develop the company strategy and drive the...

Alkermes, Inc. The Executive Medical Director serves as a senior member of the DSPV 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 individuals and highly effective teams. This leader will be expected to roll-up their sleeves and help do the work in addition to managing direct reports. Key success factors also include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently or collaboratively and to be able to...

MathWorks Summary MathWorks has a hybrid work model that enables staff members to split their time between office and home. The hybrid model provides the advantage of having both in-person time with colleagues and flexible at-home life optimizations. Learn More: https://www.mathworks.com/company/jobs/resources/applying-and-interviewing.html#onboarding. MATLAB & Simulink enable biomedical engineers worldwide to accelerate the pace of discovery in areas ranging from bioinstrumentation, biomechanics, medical imaging and optics, tissue and neural engineering, rehabilitation and surgical robotics and more. If you have experience with MATLAB & Simulink and are passionate about driving their adoption and usage in Biomedical Engineering, this is the role for you. As the Biomedical Engineering Market Development Manager, you will deploy your knowledge of MATLAB & Simulink and their applications in academia and industry, to support the company strategy and drive the...

Alkermes, Inc. This is a high impact position with great visibility across all levels of the Alkermes organization. The primary role is to drive Alkermes's clinical development portfolio in Neurology. Specifically, this position will have critical hands-on leadership responsibilities in the clinical department involved in the development of therapies for Neurology indications, including neurogenerative and sleep disorders. The Vice President will drive the strategies and clinical plans across all phases of drug development. Key domains include development of study protocols, medical review of clinical trial data and generation of clinical study reports. The Vice President will interact externally with key global regulatory authorities, industry and scientific organizations, as well as external key thought leaders. This position will work cross-functionally to ensure projects are coordinated with partners from multiple departments within Alkermes including regulatory,...

Alkermes, Inc. We are seeking a highly motivated and strategic 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, reimbursement bodies, and patients/advocates. The ideal candidate will have a strong technical background in HEOR, excellent data science and visualization skills, great written and verbal communication skills, and a proven ability to foster and manage internal and external relationships effectively. Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees...

Alkermes, Inc. Reporting to the Vice President, Regulatory 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 personnel including Regulatory, Clinical Development, Drug Safety, and Quality in support of development and maintenance of labeling content and contributes to health authority negotiations as necessary. Responsibilities Acts as point of contact for cross-functional teams on local and global labeling issues. Manages labeling development or approval. Preparation of updated Core Data Sheets and US...

Alkermes, Inc. This is a high impact position with great 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 interact externally with key global regulatory authorities, industry and scientific organizations, as well as external key thought leaders. This position will work cross-functionally to ensure projects are coordinated with partners from multiple departments within Alkermes including regulatory, preclinical research, clinical pharmacology, translational medicine, toxicology, CMC, new product planning, project...

Kaiser Permanente Job Summary: In addition to the responsibilities listed below, this position is also responsible for ensuring that research team members are working in compliance with state, federal, and institutional regulatory requirements (e.g., Food and Drug Administration (FDA) regulations, National Institute of Health guidelines, human research protection); developing and training on-site procedures pertinent to regulatory compliance in consultation with site staff; preparing Institutional Review Board (IRB) and/or FDA documents; preparing and maintaining study-related regulatory documents (e.g., protocol and consent forms, brochures, events documentation, compassionate use application); conducting or supporting regulatory quality assurance activities for the department; assisting in the preparation for and participation in internal and external inspections and audits; developing and/or maintaining policies and procedures and educating others on new guidance/regulatory...

University of Michigan How to Apply To apply for this job, please upload (combined into ONE PDF) a CV/resume, cover letter, and the names/contact information for 3 professional references. The cover letter should address your specific interest in the position and outline the skills and experience that directly relate to this position. All inquiries about the position should be emailed to [email protected] with the subject line "Research Associate Position Inquiry". Job Summary The Motor & Visual Development Lab (MVD Lab; PI: Haylie L. Miller, Ph.D.) in the School of Kinesiology seeks a full-time Research Associate to support research on neurotypical and neurodivergent motor and visual development. This position is ideally suited for someone who enjoys working collaboratively within an interdisciplinary team, engaging in community outreach, and managing research data with a high level of attention to detail. Why Work at Michigan? In addition to a career filled...

University of Michigan How to Apply To apply for this job, please upload (combined into ONE PDF) a CV/resume, cover letter, and the names/contact information for 3 professional references. The cover letter should address your specific interest in the position and outline the skills and experience that directly relate to this position. All inquiries about the position should be emailed to Dr. Elizabeth Salerno ( [email protected] ) with the subject line "Research Specialist Position Inquiry". Job Summary The Healthy Aging after Cancer Laboratory (Principal Investigator: Dr. Elizabeth Salerno, PhD MPH) in the School of Kinesiology is seeking a full-time Research Specialist to join its dynamic research group. This position is integral to supporting efforts in mixed-methods behavioral research projects aimed at improving health outcomes in cancer survivors. The individual in this role will have some engagement with the Institutional Review Board (IRB) staff, administrative...

Merck Job Description Our ability to excel relies on the innovation, integrity, expertise and teamwork of our scientists. We value rigorous scientific exploration, cross-functional collaboration, creative-thinking and dedication to building strong and operationally excellent teams. As part of our industry-leading drug development programs, you will have the opportunity to collaborate with highly talented and dedicated colleagues, working urgently to develop lifesaving medicines and vaccines and deliver the next medical breakthroughs. The Analytical Research & Development department of our Company Research Laboratories Division is seeking an experienced and highly-motivated Principal Scientist with extensive cell-based characterization assay development expertise. The successful candidate will have experience with the design, execution and optimization of a broad range of characterization assays and be responsible for development of analytical control strategies for...

Merck Job Description Associate Director, Launch Strategy & Operations US Human Health - US Pharma, Rare Disease Business Unit Location: North Wales (Upper Gwynedd), PA | Hybrid (3 days onsite) About the Role We are looking for a highpotential launch leader to join our US Human Health Specialty Business Unit as an Associate Director, Launch Strategy & Operations . This role sits at the center of how we prepare, align, and execute product launches-working across marketing, access, sales, operations, medical, and enterprise partners to ensure our launches are thoughtful, connected, and built for longterm success. This is an ideal role for someone who enjoys both strategic thinking and handson execution , and who is motivated by seeing the full picture of how launches come together across a complex organization. You'll gain a frontrow seat to enterprise launch decisionmaking, exposure to senior leaders, and experiences that can translate into future...

University of Michigan How to Apply A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position. Job Summary The Heinz C. Prechter Bipolar Research Program, located within the Department of Psychiatry, is a nationally recognized leader in advancing research for individuals living with bipolar disorder. Our work focuses on better understanding the condition, identifying factors that influence outcomes, and developing more effective, personalized treatments. Through our flagship Prechter Longitudinal Study of Bipolar Disorder, we build long-term partnerships with participants to better understand how bipolar disorder unfolds over time. Combining clinical information, treatment experiences, overall health data, and genetic insights, the study helps identify patterns in the...