6 development data coordinator jobs found

Alkermes, Inc. The Senior PV Scientist serves as a critical medical analytic and coordinating role in partnership with the Safety MD/Medical Monitor for assigned marketed and/or investigational product(s). The Senior PV Scientist is expected to be equally effective in working collaboratively or independently. She/he must demonstrate effective leadership skills with cross functional partners to ensure that signaling, safety data analyses/authorship for ad hoc queries and aggregate reports are of high quality and are completed and submitted according to required timelines. For investigational products, this role may also participate in protocol design, safety CRF development, safety monitoring plan, support of DSMB activities, coding review as well as SAE reconciliation activities. The Senior PV Scientist also plays a key role in ensuring that the above activities remain compliant with evolving regulations, that respective SOPs and work instructions regarding signaling, ad hoc and...

Alkermes, Inc. As a Project Manager, you will support Alkermes in advancing a comprehensive AI strategy through our INDIGO program, an enterprise-wide initiative to expand the impact of machine learning and AI capabilities across our business. Your role will involve leading cross-functional projects supporting the R&D AI workstream within INDIGO and partnering closely with the INDIGO Program Manager to further establish the team's agile transformation. By aligning outcomes and processes with strategic goals and ensuring that projects are delivered on time and in budget, you will be pivotal in contributing to best practices, shaping INDIGO operations, and ensuring successful outcomes on Alkermes' investments in ML and AI technologies and products. Competitive candidates must demonstrate strengths in collaboration, organization, problem solving, facilitation, communication, and thrive in a fast paced environment. They bring deep experience in agile project management,...

Alkermes, Inc. In this leadership position, the Senior Director, 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 deliverables. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work Duties and Responsibilities: Develop and lead a team of high performing statistical programmers to meet corporate regulatory, scientific, and business objectives. Deliveries of the statistical...

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. 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...