IT Project Manager Consultant – Process Development and Tech Transfer Delivers project management support and oversight for the Process Development and Tech Transfer System Project, which involves the implementation of a Process Intelligence system, and all other projects as needed by the business.This includes the all work associated with the RFI and RFP processes, requirements definition,...

Regulatory Finance Project Coordinator   Budget Activities: Internally tracks variances from budget Refines budget models Liaises with GRA contract responsible parties to ensure accurate cost codes and invoice receipt Compiles presentations on variances to GRA leadership Seeks process improvements by working with Finance and Outsourcing Helps to manage inputs from global affiliates...

Pharmica seeks a Safety Scientist to support the Pharmacovigilance department at our client site in the Basking Ridge, NJ. This is a 6-month contract position, requiring a full-time (40 hours/week) on-site presence. Duties:  The Safety Scientist, Pharmacovigilance main role is to process and evaluate adverse events (AEs) received from clinical trials and/or post-marketing sources to support...

Overview: The Executive Talent Acquisition Coordinator (ETAC) is a vital and integral role supporting the Talent Acquisition function. The ETAC contributes to the overall success of the team and candidate experience by providing a high level of customer service, administrative support, and project coordination throughout the recruitment process. This position will require you to develop an...

IT Project Manager Duties: Develop and manage detailed project plans inclusive of key milestones, critical path tasks, deliverables, and resource allocation Continually identify, prioritize, and mitigate risks of the program based on a balanced approach of best practice for Identity Access Management (IAM) solutioning, criticality of the requirements, and the impact to the key outcomes ...

With limited supervision conducts site evaluations/initiations and closeout visits in addition to routine monitoring visits, as required. Assures site compliance with the routine protocol and regulatory requirements and quality of data. Assists in the setting and updating of study timelines. Assists in CRO or vendor selection. With guidance from supervisor coordinates CROs or vendors. ...

Position Summary Incumbent will independently manage and coordinate complex drug development activities for cross functional development projects, including the project management of clinical and regulatory activities. Manages strategy development, project planning, execution and delivery oversight. Works across research, development and commercial departments to establish strategy and drive...

Position Overview: The Sr. Project Manager is responsible for the planning and execution of IT projects that includes any and all phases of the project life cycle while incorporating system development life cycle. The Project Manager is accountable for delivering projects on time, within budget, and with high quality. This position focuses on the implementation of projects within the area of...

Support the Associate Director, Integration & Innovation to implement a roadmap for emerging digital technology (e.g. artificial intelligence, electronic health record, etc.) to drive client into next generation technology. Facilitate in the development of a strategic roadmap for enhanced data mapping from source to reporting in both data visualization platforms and in delivery to the Quantitat...

Knowledge Demonstrated knowledge of business use of regulatory technologies, including Publishing, EDMS, Submission tools, regulatory information management (RIM), and Identification of Medicinal Product (IDMP), and related regulatory requirements. Working knowledge of pharmaceutical industry regulatory-related laws, regulations, and guidance. Solid understanding of the FDA, EMA, and Health...

IT Manager III   Specific Responsibilities and Skills • Work with application teams to determine prioritized automation requirements for projects • Analyze requirements to break down into features and organize features into sprints • Develop, test and deploy automation to implement requirements • Maintain automation as new functional and non-functional requirements are determined •...

Essential Duties and Job Functions: • Work collaboratively with global and regional regulatory product leads in supporting global clinical and nonclinical regulatory strategy development, planning, and implementation for multiple complex programs across the Gilead liver franchise • Provide regulatory guidance and critically review documents to ensure alignment of rest of world submissions and...

The Regulatory Document Specialist II, Submission Operations, is accountable for managing the routine and non-routine submission activity for client's portfolio. The Regulatory Document Specialist II, in collaboration with the Regulatory Lead, designs and executes high quality global submission plans, ensuring client delivers compliant submissions to global health authorities within required...

Responsible for managing service delivery of core commercial applications; Veeva CRM, Veeva Align, Salesforce Service Cloud, Veeva PromoMats and other applications supporting these core applications. He/She will manage a team and work closely with IT Business Partners, Commercial Operations and IT development teams to ensure service delivery for projects, enhancements and production support....

Drug Development Project Manager Pharmica is seeking an experienced Drug Development Project Manager to help our client, in San Francisco. This is a full-time position, managing 2 pre-clinical gene therapy programs.   Responsibilities: Provide project leadership and management to pre-clinical programs and work collaboratively with global, cross-functional team members Assist in defining...

We are seeking a highly motivated individual to join us as a Program Manager, Medical Communications. This role is responsible for creating and managing core scientific content and for leading medical affairs advisory board meetings and congress activities. The Program Manager, Medical Communications will work with in-house medical directors to execute advisory board meetings and investigator...

Global Clinical Supply PM Position Summary The Program Execution Team Leader is the key program & project manager and operational/tactical team leader for the Global Clinical Supply and Global Program Strategy Group (GCS/GPS) for one or more early or late stage development asset. He/she provides global project management support to the Global Program Strategy Team(s) (GPST) in Global...

Responsible for the management and implementation of strategic plans and projects within the Global Medical Communications organization. The Project Manager will coordinate and collaborate with the Global Medical Communications leadership team on execution of core projects as well as on the implementation of systems and operations in support of the Scientific Communications (Publications /...

Duties: - Receive and process requests within the company eDMS for controlled document creation, changes, or withdrawal (Document Control, Change Requests). - Maintain tracking and processing of controlled documents relating to company Periodic Review process. - Maintain the system for records and retention using a standard categorization system in accordance with internal and regulatory...

The project manager of data analytics will be the point person for several data analytics projects. The PM will interview stakeholders, develop project plans, develop change management plans, etc. The DA PM will work with the PMO to report status and issues. Required Skills at least 5 years of pharmaceutical experience experience with data analytics is helpful experience with marketing or...

The Global Project Manager (GPM) is the operational leader for the development programs and provides project management support to the Global Development Teams (GDT). The GPM is responsible for management and delivery of the integrated development plans for their programs. In collaboration with the Global Development Team Leader (GDTL) and the GDT, the GPM drives development plans to ensure that...

Experience Partner with the business to understand SharePoint sites and what needs to be migrated Work with business to move custom sites to out-of-the-box sites in SharePoint. Develop solutions to satisfy requirements and articulate to the business Lead junior SharePoint Migration consultants on what to do pre-migration and review sites post migration Develop SharePoint sites as needed ...

Experience Work with business to move custom sites to out-of-the-box sites in SharePoint. Develop solutions to satisfy requirements for the business Collaborate with senior SharePoint Migration consultants on what to do pre-migration and review sites post migration Develop SharePoint sites Provide training as needed Qualifications Migration experience is very helpful at least 2 years...

Drug Development Team Project Manager Pharmica is looking for an experienced Drug Development Project Manager to support global, clinical-phase, Oncology programs. Responsibilities Provide project leadership to global, cross- functional teams in all phase drug development projects or sub projects designed and coordinated to achieve the organization’s strategy. With minimal direction from...

Pharmica is hiring a Regulatory Project Coordinator in the Princeton, NJ area! This individual should have 1-3 years experience in the field. Drive Global Regulatory Affairs (GRA) projects, initiatives and innovation activities Actively engage and collaborate with the Innovation/initiative leads and other GRA leaders to achieve the goals set out in the innovation agenda Coordinate cross...

We are looking for a Regulatory Project Manager to drive global Regulatory Affairs projects, initiatives and KPI generation. Actively engage and collaborate with the Innovation Lead and other GRA leaders to achieve the goals set out in the innovation agenda Lead and coordinate cross-organizational innovation initiatives and ensure that team members are aware of and meet all expected...

Job Description: The Clinical Systems Analyst role supports activities pertaining to data strategy, systems, reporting and analytics in Global Clinical Operations (GCO). This includes supporting a wide range of dashboard development, running of recurring reports, ad-hoc analyses and oversight of operational data quality, as well as key processes related to data capture/output in clinical trial...

Senior CMC Product Manager Pharmica is seeking a Sr. CMC Product Manager to help drive the overall success of development & commercial programs within Manufacturing & Technical Operations at our client site in South San Francisco. Responsibilities · Work collaboratively with the Technical Leads and CMC Sub-teams to plan, track and report the diverse activities managed by Manufacturing &...

Duties: Case Processing: Interacts with vendors, CROs, and partners on a daily and as-needed basis. Escalates issues and develops resource strategy with senior management. Vendor Case Management: Lead for PV CRO/vendor projects and ongoing management oversight. Monitors CRO/vendor reports (daily, weekly, monthly as required by project) to ensure quality completion of deliverables.Responds to...

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...

A Principal Clinical Data Manager (PCDM) has a keen attention for detail and is responsible for overseeing the start-up and execution of several trials with a CRO or in-house to ensure data quality and integrity. PCDMs will independently lead multiple, high volume and extremely complex studies within a development program. The individual will perform a variety of complex tasks to ensure complete...

The Project Manager must generally be steeped in the business of drug development with the ability to take on work from the client team and advance agreed upon deliverables with a high degree of independence.They must be comfortable working with teams and articulate both verbally and in written communications. MS Project is the key medium by which timelines are developed and any candidate must...

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,...