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...

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,...

Executive summary: -Product and project team support - individual who supports team activities e.g. Clinical Regulatory Teams, project sub-teams, review documents e.g. CRO regulatory and ethics submissions plans, Letters of Authorization, protocols, reports, and prepare documents as needed (e,g. regulatory meeting packages, letters for specific health authority issues. -Ad hoc resources for...

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...

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...

Pharmica Consulting is looking for a Pharmacovigilance Business Intelligence Consultant. Position duties include: Responsible for managing PV reports Familiar with PV data Experience with Argus is a big plus Experience with business intelligence tools, such as Spotfire Work with end users to understand report needs then build reports in Spofire Write some basic SQL code (counts, sums,...

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...

Project Manager will be responsible for leading a complex cross functional project. Responsibilities Include: Define project scope, goals and deliverables Define tasks and required resources Develop and manage project budget Allocate project resources Create schedule and project timeline Track deliverables Support and direct project teams Monitor and report on project progress ...

The Program Manager is responsible for the planning and ensuring the execution of interconnected projects within the Securing the IT Enterprise Program. The Program Manager is accountable for delivering projects on time, within budget, and with high quality. The program manager will work closely with the individual Project leaders, IT Business Partners, and Solution Delivery Managers, serving as...

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...

Project Manager is responsible for developing and managing a newly proposed clinical trial Patient Portal Project inclusive of cost, time and scope. Key activities will include developing and maintaining project plan, communication plan, issues/risks log along with allocating tasks, setting milestones, and collaborations with multi-stakeholders and vendor. Responsibilities: Using project...

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....

Brief Description:  Leads safety data management projects Collaborates with internal stakeholders to deliver projects on time and on budget Works closely with vendors to evaluate, select and implement PV software Collaborates with IT and PV to optimize existing systems in PV Works close with other PV project managers to understand the big picture as well as the specifics for your...

The Project Manager for the Global Clinical Trial Public Inquiry Project will support the Head of Clinical Trial Transparency to implement the strategic vision for optimizing how we respond to clinical trial inquiries across the portfolio from various stakeholders (patients, HCPs, etc.) across the globe. This will involve transitioning the current state process to a new department, developing a...

Job Description We are seeking a CMC Project Manager to help drive the overall success of development programs within Manufacturing & Technical Operations. S/he will work collaboratively with the Technical Leads and their project teams to plan, track and report the diverse activities managed by Manufacturing & Technical Operations. This includes, but is not limited to, process development,...

We are looking for a Clinical Quality Assurance (CQA) Project Manager. Duties: Project management to lead program teams through the activities of preparing for worldwide health authorities inspections following marketing applications Managing program team meetings Develop agendas, track actions, and communicate meeting outcomes. Ensure plans are implemented in accordance with timelines...

We are looking for a Clinical Quality Assurance (CQA) Project Coordinator with a focus on inspection readiness.   Duties: Lead some clinical operations sub-teams through the activities of preparing for worldwide health authorities inspections following marketing applications Managing team meetings Develop agendas, track actions, and communicate meeting outcomes. Ensure plans are...

Responsibilities The project manager will report to the Sr. Director of Project Management. The project manager will work closely with the production, analytical and quality teams in San Diego as they prepare for and execute on the production and release of this investigation vaccine. The project manager will partner with the project leader to support or facilitate bi-weekly core team meetings...

·Experience in immuno oncology or rare disease ·On site 4-5 days/week ·Partner with program lead or medical lead ·Influence stakeholders ·Build timelines ·Regulatory interaction and BLA experience is helpful but not necessary ·Clinical experience helpful ·MSP experience ·Expand to other programs. Help other program leaders

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 ...