The Project Manager role is the liaison with assigned functional area for the purpose of business and digital alignment, business technology strategy support, solution discovery, service management and relationship management. This individual will be responsible for supporting both the Finance and Procurement organization stakeholders and our 3rd party service providers to implement OpenText® for...

IT Program Manager/Agile Coach The Program Manager oversees the execution of projects, is responsible to ensure the business requirements are met, the process is followed, and all issues and risks are well managed. The position requires strong collaboration, communication, leadership, and change management skills as well as experience driving complex projects using agile, waterfall, and hybrid...

GMA Training & Resources Operations Manager    Job Description: The GMA Training & Resources Operations Manager will create and maintain an efficient system of operation to support the business needs of the dept. and be able to effectively multitask and work cross-functionally with different business units & departments.   Responsibilities • Maintain business standards for accuracy,...

Remote GMA Training & Resources Development Medical Writer    Job Description: • The GMA Training & Resource Development medical writer will be responsible for researching, writing, and editing disease state and product materials.   Responsibilities: • The medical writer will develop copy content for outlines, design documents, electronic storyboards, presentations, assessment questions,...

The Epidemiology Associate is a strategic and scientific role accountable for developing, coordinating, and executing cutting-edge, effective, and impactful epidemiology deliverables for their assigned registry. The Epidemiology Associate will lead their assigned registry in project planning, management, and execution of epidemiology deliverables to ensure efficient and accurate completion within...

We are seeking a talented BI Analyst to join our client's Quality Management System (QMS) Metrics and Reporting team, which focuses on delivering a scalable data infrastructure to enable agile reporting of our Quality Data. One of the key objectives for the BI team and this role specifically is to improve the Data Visualization and Reporting services for the Quality organization and its external...

The IT Project Manager will be responsible to manage the project team. The candidate will be working closely with Commercial Operations and I&T teams, as well as our selected 3rd party partners. Activities will include effectively leading and managing the project in alignment with strategic and operational priorities; motivate the project team to achieve project objectives through successful...

Quality Assurance Associate Description: • Ensures GMP compliance for outsourced clinical manufacturing, packaging, labeling and testing activities. • Performs QA review of manufacturing and packaging batch records for OPDC research & development products for accuracy and compliance with Client and GMP requirements. • Reviews and approves analytical test results/raw data to ensure results...

The Medical Affairs Manager will be responsible for overseeing and assisting with digital medicine and digitaltechnology projects, in alignment with the Medical Affairs goals and initiatives. Project work will mostly support commercialized programs. Job Functions include, but not limited to the following: • Supports the provision of medical, scientific, and technical information regarding...

• Overall responsibility for the Program Management of all systems being integrated successfully by year’s end • Overall responsibility to ensure ALL relevant artifacts are created, managed, maintained, and leveraged throughout the entire program • Collaborate across the various business units to ensure alignment is attained, both process and technical • Collaborate across the Enterprise to...

Regulatory Operations Associate The manager Regulatory Operational Excellence supports the oversight of regulatory compliance including procedures and RIM metrics/KPIs. This role will also support service provider management. The essential functions of this role are: The establishment and review of KPIs/metrics to identify and escalate compliance risks appropriately to senior management and...

Commercial Strategy Project Manager Responsibilities • Supports the project teams toward implementation of the strategic and operational plans and tracks progress to goals. • Identifies and tracks risks and issues related to scope, timelines and budget. Escalates as appropriate, to ensure timely resolution. • Manages project information and develops good relationships with colleagues to...

Manager, GMA Oncology-Clinical Trial Management & Resources Job Summary: The Manager, GMA Oncology-Clinical Trial Management & Resources will provide support for all aspects of Global Clinical Operations with high degree of quality in the execution of Externally Sponsored Research (ESR) studies in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food...

The position holder is responsible for both scientific input to clinical development strategies, acting as the primary liaison between the assigned therapeutic area and key stakeholders to ensure translation of the development plan into operational deliverables. Contribution to the scientific content of clinical program documents is a key deliverable and includes study synopses and protocols,...

Associate, GMA Oncology-Clinical Trial Management & Resources Duties: Provide support for all aspects of Global Clinical Operations with high degree of quality in the execution of all Global Medical Affairs medical activities in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and Internati...

Actively develop new technologies for the purification of plasma proteins. Responsible for driving innovation and development of novel technologies in all aspects of therapeutic protein purification. Identify and drive collaborations with external partners, serving as co-author on research proposals and actively evaluating technologies as part of Joint Research Committees. Be technical expert in...

Pharmica Consulting is looking for a Human Resources Policy Specialist for our client in the King of Prussia, PA area. This role will be mostly remote but may require some on site time for the duration of about 6 months. The Policy Specialist is responsible for the development and maintenance of the HR Policy library through partnership with Subject Matter Experts throughout the HR organization. ...

This position has primary responsibility for ensuring that there is appropriate local PV system oversight in the US, including any elements of the PV system that are contracted to a third party. This includes responsibility for ensuring there are processes and systems in place for the management of adverse event (AE) reports which comply with global and local requirements and execution of...

Business Analyst (Argus) Job Description: This position will be responsible for the management of safety data-related activities in the Drug Safety team such as, but not limited to, generating listings from the safety database, peer review of safety database queries, coordinating Argus user access & database changes in collaboration with IT, participation in implementation & testing of system...

Responsible for the management, overall coordination and status reporting of technical projects. Develop project plans to ensure projects are delivered on time, within budget, adhere to high quality standards and meet customer expectations. Work with clients to understand and translate their needs into IT system requirements and solutions. Builds business cases to support recommended solutions. ...

The Global Development (GD) Change Manager is responsible for driving GD change initiatives in order to enhance and streamline the project delivery platform for non-portfolio projects. The GD Change Manager will ensure a standardized approach and application of RGDCM capability across the DO&PM GD Shared Services function. The GD Change Manager will oversee implementation of such in order to...

The Project Manager role is the liaison with assigned functional area for the purpose of business and digital alignment, business technology strategy support, solution discovery, service management and relationship management. • Lead project planning sessions ensuring involvement and presence of required stakeholders from Business and I&T. Manage various sized, diverse and geographically...

The Project Manager manages the delivery of key HR projects in collaboration with sponsors and stakeholders. This role provides coaching and support to “part-time” project managers through project definition and implementation. Leads project planning ensuring the presence and involvement of required stakeholders. Manages diverse and geographically distributed project teams and ensures a healthy...

This role has accountability for infrastructure delivery of assigned Plasma Center Infrastructure activities with a focus on delivery of small-medium size Plasma infrastructure projects and represent the B@B (Brilliant at the Basic Program) and support the Assessment and Remediation workstreams. This role will work with The Group’s I&T Business Partners, Plasma Centers, Plasma Operations and other...

The Stakeholder Engagement Project Manager will play the lead role in analyzing, planning, and implementing stakeholder engagement strategy for Central Quality Systems and Compliance. The project manager will work to convey the voice of Central Quality System and Compliance (CQSC) through various long and short-form communications products (including newsletters, emails, and videos) aimed at...

We are looking for a Lab Manager consultant for our client in King of Prussia, PA. This role will require on site time so must be commutable to KOP.  The Lab Manager will provide development support to Breakthrough Launchpad projects through thorough and meticulous laboratory work. Assist in the development and utilization of new purification processes to purify plasma proteins. Perform routine...

Actively develop new technologies for the purification of plasma proteins. Responsible for driving innovation and development of novel technologies in all aspects of therapeutic protein purification. Identify new opportunities for collaborations with external partners, serving as co-author on research proposals and actively evaluating technologies as part of Joint Research Committees. Be technical...

Strategic Program Manager Support for Digital Therapeutics   PM will coordinate across multiple commercial functions to develop and maintain launch plans, assist in strategic asset planning, and contribute to other core commercial activities. Strategic Project Management and Launch Management responsibilities:   • Determine project management methodology per project, manage project...

Job Summary: The Technical Lead is responsible for managing a development team, while also providing support for our partners on the Client Services team. The Technical Lead creates new product features in JavaScript and comfortability supporting and improving existing features. Essential Functions:  · Design and develop products supporting the Intrinsic Insights Suite. · Manage on shore and...

Trial Master File Manager III Job Description: eTMF Administration • Support eTMF Business Administrator for user account management, create and promote studies in the eTMF, and unblinding • Act as Subject Matter Expert for eTMF management • Ensure suitable reports and outputs are built to support TMF Quality • Oversee the management of ask TMF mailbox and FAQ log TMF Quality •...

The Global Trial Leader (GTL) has primary global accountability at the trial level within the Global Development (GD) organization. The GTL is accountable and provides operational expertise for the successful cross-functional delivery of assigned global clinical trial(s), within agreed timelines and budget, and in alignment with all the applicable SOPs and regulatory requirements. The GTL is...

Oversees the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions. Coordinates inspection of the organization and contract facilities, and develops procedures to ensure regulatory compliance. Requires a bachelor's degree in area of specialty typically requires 5 years experience in the related area as an...

Drug Development Project Manager Position Overview: The Project Manager (PM) works with a wide variety of cross functional teams including development partners to achieve key development milestones for a Contract Manufacturing Organization (CMO). The PM is responsible for management and delivery of integrated development and manufacturing projects and programs, ensuring alignment with line...

CMC Program Manager Position Overview Reporting to the SVP Program and Alliance Management, the CMC Program Manager is responsible for the management of integrated CMC development and manufacturing projects ensuring alignment with line functions and across strategic/operational/tactical plans, in support of the overall objectives and priorities of the program. This position is with a Contract...

Assist the CPLs for the planning, implementation, execution and compliance of operational plans for clinical study/program with multiple clinical vendors in order to maintain inspection readiness. This is a tactical position and involves protocol execution at the site level via established vendor oversight and escalation pathways. Serve as a peer mentor for staff, as needed. Ensure quality of the...

R&D Outsourcing Strategy and Execution partner with teams and leverage supplier market landscape to develop an optimal outsourcing strategy and execute competitive agreements supported by outsourcing excellence that enable speed, quality, business transformation, and efficiencies for R&D categories of services to increase probability of success. This role leverages agile contract management...

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,...

• Partner with management and team members to create clear communications • Ensure timely execution of communications’ initiatives to support internal initiatives • Measure success metrics and monitor change progress • Support change management at the organizational level • Connect with key players in the organization to ensure a successful delivery of messaging • Identify communicatio...

We are looking for a Technical Project Manager for our client in King of Prussia, PA. This consultant will be required on site 3 days a week. The PM is responsible for managing and delivering the I&T scope of IT infrastructure projects for our global IT operations. The candidate will be working closely with the Operations and I&T teams. Activities will include effectively leading and managing the...

• This role is to support their oncology pipeline. • They need project management support with their regulatory submissions – mostly this would cover EU submission activities, but the client team are split between US and EU (Germany). • This is someone who will be embedded with the client’s project team and functional leads • Develop a project plan according to client deliverables •...

Key Responsibilities: • Resource manager for R&D organization. This is a leadership role that will be accountable for partnering with R&D functions, HR, and Finance to maintain and manage a portfolio of open R&D headcount • Ensure full trace-ability of open headcount across R&D, Finance, and HR • Manage the Resource Management Team – this is a forum of operations leads from each of the R&D...

Corporate Affairs Project Manager- Some onsite time required so must be commutable to NJ or DC Summary: This Project Manager (PM) will execute medium to high-level projects in the Corporate Affairs (CA) function. As background, CA consists of four sub functions from which projects may arise: • Government Affairs • Patient Advocacy and Stakeholder Management • Corporate...

We are seeking a Launch Project Manager to support the launch of a new dosage strength and a new indication for marketed products. • Breadth of experience managing key “Launch minus 1 year” activities in Commercial (Marketing, Market Access, Sales), Medical Affairs, Regulatory, and Supply Chain • Partners with stakeholders at both Alliance organizations to manage the creation of the Launch...

The Portfolio Manager partners with franchise leaders to prioritize, plan and execute drug development and in-line portfolio efforts. Projects may be internal or part of alliance agreements with external research and development partners. The Portfolio Manager is a subject matter expert in conducting enterprise wide portfolio reviews to manage cross-functional and cross-divisional product...

We are currently seeking a Project Manager consultant (PM) experienced in Pharmaceutical Drug Product Development with direct experience working on submission timelines and regulatory teams. She/he will serve as a PM supporting the lead Regulatory PM. The primary responsibility will be to provide project management expertise and support to core- and module sub- teams, ensuring that the project...

CW CMC Regulatory Affairs Manager role  Role Description Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure client's products are developed/maintained in compliance with global regulatory requirements and guidances. Primary regions/markets of responsibility include US...

Job Description: The Technical Medical Writer (CMC) is a writing-based position within our Global Regulatory Affairs department. He/she will ensure communications are complete, well organized and scientifically accurate, and that messaging is consistent throughout all technical documentation (Module 2 and Module 3). - Proactively manages writing activities across assigned projects as appropriate...

Position Summary: The Director, Program Management is responsible for supporting the sparsentan development program, currently in Phase 3 development in rare kidney disease indications (FSGS and IgAN) and preparing for product registration, commercialization, and launch. In addition, this position may support other programs, corporate initiatives, or additional products that may be added to the...

The Associate Director, Project Management is an integral member of the Product Development Teams. The incumbent, in collaboration with the project leader and team, generates a comprehensive New Drug Integrated Development Strategy. As a senior, highly experienced team member, the Associate Director, Project Management is responsible for monitoring the execution of the Drug Development Project...

We are seeking a Contract Human Resources Generalist who will be responsible for the day-to-day HR needs of the organization in Hayward, CA. The ideal candidate is HR savvy, personable, detail oriented, highly organized, and eager to learn. As a Contract HR Generalist, at the direction of HRBP leadership, you will create a strong partnership across the business and help to drive great employee...

Change Management, IT User Experience Consultant The Change Management, IT User Experience Consultant will be responsible for helping clients implement the IT projects, which includes the Microsoft stack as well as other types of IT projects. • Help change team with IT User Experience Book of Work focusing on projects with low to medium end user impact • Assist with stakeholder management...