Project Manager Consultant – Process Intelligence and Data Historian Delivers project management support and oversight for the Process Intelligence System and Data Historian (OSI PI) Projects, which involves the implementation of a Process Intelligence system, Data Historian application, and all other projects as needed by the business.This includes the all work associated with the RFI and...

Project Manager Consultant – MES Delivers project management support and oversight for Manufacturing Execution System (MES) Projects, which involves the implementation of the MES system for electronic logbooks and all other projects as needed by the business.This includes the all work associated with the RFI and RFP processes, requirements definition, configuration, validation, cutover to...

Job Description The Drug Development Project Manager acts as a central contact for information on a particular program and manages activities to develop programs. Ensures that concurrence between the team and management is achieved for program objectives and meets these objectives to achieve goals. Works with management staff and teams to create the development strategy, establish objectives,...

The project manager is responsible for project management, roadmaps, analysis, communication and documentation, reporting, budgeting and other tasks.   ROADMAPS: Partner across business teams to sustain the PSE JJOS deployment roadmap in CASCADE tool ANALSYSIS: Adhoc, Excel based analysis (trending, paretos, pivot tables, etc.) of process data (inventory levels, cycle times, failure modes,...

The Medical Affairs Project Coordinator responsibilities will include, but are not limited to, facilitating complaint investigator-sponsored study (ISS) and grant processes within the Medical Affairs management system, supporting global expansion of the Medical Affairs management system, coordinating departmental budget & forecast activities, and playing key role in operational process improveme...

The PV Coordinator will work on the Pharmacovigilance team and support a group of Project Managers. Responsibilities include: Provide analysis on PV data Help with process improvement efforts Understand PV data, conduct analysis, provide recommendations Comfortable using systems Manage projects to completion Work with PV Project Managers to complete deliverables for projects Required...

QMS-LMS-DMS Implementation Business Analyst  Provide implementation support for Quality Management System, Learning Management System and Document Management System Partner with the Quality team to clearly document business requirements Engage with additional stakeholders in Quality Assurance to identify and understand their requirements Model current and to-be business processes with...

Pharmica is seeking a Medical Affairs Project Manager. Responsibilities: Partners with US Medical Affairs Oncology and stakeholders to manage the creation of the Medical Strategy and Objectives Collaborates with functional owners in Medical Affairs to define and maintain a detailed project plan in alignment with overall Medical Strategy and Objectives Reports the progress of Medical...

Pharmica Consulting is looking for a SharePoint Project Manager.  Description Meet with functional stakeholders to understand process improvement opportunities Use SharePoint and the Microsoft stack to implement process improvement projects Collect requirements, develop prototypes, review prototypes, make recommendations to team Implement projects by emphasizing best practices, training,...

Roles/Responsibilities: Develop an in-depth understanding of the contingent workforce strategy. Partner with Financial Planning and Analysis, Strategic Sourcing, Legal and other Business Partners to ensure a robust understanding of the Contingent Workforce ecosystem across the client. Consult and advise on contingent workforce process. This will include overall strategy, quarterly and...

Responsible for the management of one or more medium to large sized, moderately to highly complex projects. Manage the effort end-to-end with oversight of both internal and external resources. Responsible for scoping, planning, executing, and monitoring the project. Will need some level of expertise in one or more of the following areas: Project Management, Resource Management, Finance Managemen...

Key Responsibilities: Independently prepare for and conduct clinical investigator site audits and external service provider (ESP) audits of CROs, SMOs, laboratory, and directed audits both domestically and internationally Assist with other external audits (bioanalytical laboratory audits, software vendor audits, packaging facility audits) as assigned Independently conduct internal systems...

Summary of Key Responsibilities R & D focused project management for global regulatory filings Support development of detailed regulatory project plans and timelines in close collaboration with Regulatory Operations Leads and filing sub-team leads Maintain real-time filing timelines and track deliverables for components or modules of NDA/MAA submissions from filing through registration ...

Duties: Clinical Project Lead (CPL) is responsible for and manages study deliverables through internal and external resources and is the primary point of contact and interface between these functional groups, investigator sites and vendors. Direct the execution of clinical trial activities in accordance with Client SOPs, ICH Guidelines, and Good Clinical Practice (GCP). Ensure compliance of...

The Project Coordinator should have the skills to take meeting minutes, edit MS Project timelines, edit and organize electronic files, understand and edit budget spreadsheets, and generally interact with Project Managers and team members to plan and organize the work.   Required/Preferred Capabilities: ·Ability to work with teams to record meeting minutes and track action items ·Strong...

Position Summary Leads preparation, review, and update of content for the development and maintenance of labeling and labeling components. They will demonstrate a high-level understanding of labeling content requirements, regulations and guidance in support of labeling strategies. May be assigned additional responsibilities as deemed necessary. Develop and maintain Target Product...

Brief Description: Remote position Strong experience in safety signal detection Experience with FDA Sentinel Initiative - especially with CDM 7.0 and CCS 2.0 Experience with AE reporting and analytics Ability to provide subject matter expertise on all of the above in order to help client build a system that will give them insights based on Sentinel, EHRs, etc. Requirements: Minimum...

Global Labeling Operations Manager Position Summary The successful candidate will be results-oriented with concerns for quality and collaboration. They will show initiative and want to continue to develop and acquire new expertise. Responsibilities of this position will include collaborating across the company, affiliates and alliance partners on an effective and efficient process for the...

Principal Clinical Data Manager IV The Senior Manager of Global Clinical Data Management (GCDM) is responsible for directly and independently managing internal staff and vendor relationships to ensure that budgets and timelines are developed by utilizing proactive strategies based on metrics and forecasts in order to deliver high quality data on time and within budget scope. This position is...

This Project Manager is responsible for facilitating the medical safety review team meetings and the global quality regulatory safety team meetings (MSRT and GQRST). Person must facilitate global meetings in a scientific/safety discussion. This person reports to the medical safety lead in Japan. 5-10 years of clinical PM/study PM experience. Excellent communication skills Experience...

The Clinical Trial Transparency lead will be an expert on listing clinical trial protocol and trial results on public websites (ClinicalTrials.gov, EudraCT, EU PASS, Germany and company webpage). As the CTT lead, he/she will oversee all work outsourced to the vendor and is responsible for ensuring compliance with legal/regulatory requirements (e.g. US Final Rule) and industry commitments (e.g....

Project Manager is responsible for developing a true project management capability within the client's study management group Responsibilities: Manage overall project plan and lead project team. The end goal of the project is to ensure that studies are managed using a true project management framework, including tools and templates to facilitate standardized and consistent study management ...