Write and edit lean clinical regulatory documents companywide for sense, clarity, accuracy. Provide writing support for a wide range of documents, including investigator's brochures, clinical study protocols and reports, integrated summaries, literature reviews, and SOPs. Work with the lead writer to create, manage and communicate the document timeline to ensure all revie

The Manager, Data Management & Operations will bring data management experience and technical skills to manage the end to end life cycle of commercial data. The Data Management and Operations Role function is to set up proactive data quality checks, act as data stewards, focused on the day to day data operations & management tasks. This work will require collaboration wit

Attend multi disciplinary team meetings, representing the CDI&S function. Create or review and approve statistical programming plans at study and project level. Provide input on key study related documents produced by other functions (e.g. CRFs, Data Management Plan, etc.). Create or review and approve CDISC compliant datasets and corresponding documentation for electroni

The Associate Director, Compliance & Ethics Data Analysis and Operational Excellence reports to the VP, Chief Compliance & Ethics Officer and is responsible for managing the data analytics and system modernization efforts to improve the effectiveness of Jazz's Compliance & Ethics program [referred to as I CARE (Integrity, Compliance, Accountability, Respect and Ethics)].

Support the development and deployment of the long term training, policy, and communications strategy for the I CARE program, while performing the day to day tasks required Oversee Jazz's global I CARE policy governance framework Setup and lead a cross functional I CARE Policy Management Network, in collaboration with global business functions and I CARE business partners

Partners with PV system stakeholders in R&D, Tech Ops and Commercial to monitor trends in regulatory inspection activities to proactively identify potential areas of risk, and develop proposals to mitigate against such risks. Collaborates with local site teams (e.g., IT, Facilities, R&D, Administrative Support, etc.) to ensure logistical support during inspections and aud

The Senior Principal Statistician, Biostatistics will be a lead statistician on individual studies, across related studies, and for integrated summaries and will design and report Phase I to IV clinical studies and regulatory filings under the supervision of a more senior statistician. This role is responsible for all statistical aspects of study design, study analysis an

Provide field based scientific exchange and communication of FDA approved and pipeline products In support of FDA approved products, work within the Medical Science Liaison team's objectives Identify, establish, and maintain scientific relationships with opinion leaders regarding disease state and product specific information Facilitate scientific development of pipeline

If you are a Jazz employee please apply via the Internal Career site Jazz Pharmaceuticals plc (NASDAQ JAZZ) is a global biopharmaceutical company whose purpose is to innovate to transform the lives of patients and their families. We are dedicated to developing life changing medicines for people with serious diseases often with limited or no therapeutic options. We have a

Innovative Solution Delivery Conceptualize, create, and implement cutting edge and interactive solutions to enhance customer experience within the Sleep business unit. Data & Analytics Incorporate a robust focus on data analytics and real time solution design within technology solutions. Work seamlessly with cross functional teams to achieve successful outcomes, utilizing

Provide subject matter expertise (SME) in Biologics Formulation and DP process development including lyophilized presentation development. Author and review CMC modules of IND and BLA filings Support tech transfer of biologics drug product processes to commercial scale contract manufacturing organizations (CMOs) Serve as Person in Plant (PiP) during batch production to ac

Essential duties and responsibilities may include all or some of the following The ARM will implement strategies that achieve Business Unit and Corporate goals and objectives. Analyze Data and develop Action Steps. Establish and maintain strategic relationships with assigned providers and provider accounts. Educate and enhance awareness of patient access services and prog

The Statistical Programming Group within the Department of Biometrics is responsible for developing software for the analysis of clinical study data in accordance with departmental SOPs and guidelines. Essential Functions Attend multi disciplinary team meetings, representing the programming function. Create or review and approve programming plans at study and project leve

Provide field based scientific exchange and communication of FDA approved and pipeline products In support of FDA approved products, work within the Medical Science Liaison team's objectives Identify, establish, and maintain scientific relationships withopinion leaders regarding disease state and product specific information Facilitate scientific development of pipeline c

Development of the pharmacometrics strategy of multiple programs Design, perform, interpret and report population PK, PK/PD and exposure response analyses Provide hands on population PK and PK/PD modeling and simulation support for development projects, e.g., dose selection and optimization Clinical study protocol design, data analysis/interpretation, and reporting of stu