The Product Manager will play a pivotal role in shaping global marketing strategy for assets in various stages of development. In collaboration with the global brand team, this individual will play a key role in shaping the market and building brands by developing launch/pre-launch strategies for priority assets with the goal to transform lives around the globe. This role works closely with the...

This role will provide help with the data review exercise in support of an upcoming database lock Key Responsibilities: • Review of detailed clinical study data for two pivotal UC Ph 3 trials during ongoing data cleaning initiative • Look for potential missed AEs • Ensuring consistency between clinical significance and potential AEs • Confirming inclusion/exclusion eligibility •...

An experienced project manager to help the Cyber security organization deliver new capabilities and/ or remediate existing issues. The ideal candidate will have direct experience managing project in the cyber security space. Job Description: • Managing the timelines, budgets, resource scheduling, vendor, procurement management needed to deliver new or enhanced systems and capabilities •...

Business Analyst – Argus Drug Safety System 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 &...

Essential Duties and Responsibilities • The Senior Manager, Quality Assurance will work directly with senior leadership to execute, manage, and enhance QMS across the organization. • This is a highly-visible role within the organization and the incumbent must be solution-oriented in their approach to handling Quality and compliance challenges. • This is a broadly-focused quality role,...

Remote Case Management Specialist Pharmica is looking for a Case Management Specialist to provide case processing support. The position can be performed remotely, but all candidates must be West Coast based. This is a global a team, and candidates will need to be flexible to support across all time zones globally as needed. Job Description: • The Specialist will participate in the set-up and...

Drug Safety Associate Pharmica is looking for a Drug Safety Associate with case management and quality check (QC) experience. This is a global a team position, based in the US and can be performed remotely. All candidates must have flexibility to work within PST and EU/ Oxford, UK time zones as needed. Job Responsibilities: • Responsible for performing a wide variety of tasks related to drug...

Managing, overseeing, and integrating/coordinating clinical functions, CROs, and vendors for the operational planning, execution, and reporting of clinical studies Contributing to the Clinical Development strategy by providing Clinical Operations and Project Management expertise: generation of aggressive (but realistic) clinical study operational plans in alignment with asset development...

Senior QA Engineer  The QA Engineer is responsible for the planning, management and execution of testing for Intrinsic software. The position works closely with ICS clients, architects, developers, testers and the project team to successfully test Intrinsic products. We are looking for a QA Engineer that can understand, write and test complex concepts and explain to clients and internal team...

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...

We are looking for a part-time CMC project manager with a strong technical drug development background to support its Chemistry, Manufacturing, and Controls (CMC) teams. The successful candidate will work closely with the CMC teams to: provide project management support for ongoing development programs as well as coordination of regulatory filing activities, management of documentation, tracking...

The Project Manager, GPV Strategic Management is a position responsible for a portfolio of planned, active, on-going strategic projects and governance programs. This portfolio offers opportunities for PV innovation and technical development (i.e. business process automation, database upgrades), affiliate/alliance partner integration, process development and improvement, improvement in compliance...

Pharmica is seeking a talented CMC Project Manager to play a key role in a client's Pharmaceutical Sciences function in the Boston, MA area . The role will report to the Technical Operations (TechOps) Lead, and we are seeking an experienced individual to drive the delivery of pipeline assets and technical projects. The CMC Project Manager will be responsible for Clinical-staged programs and...

The Study Start-Up Manager will own key deliverables on the clients late-stage clinical trials and serve as a primary point of contact interfacing between functional groups, investigator sites and vendors. The Associate Director, Clinical Operations will report to the Head of Clinical Operations. Responsibilities: • Under direct supervision of the Head of Clinical Operations, manage the...

The Acquisitions Integration Project Manager will be responsible for leading the integration efforts of acquired companies processes and systems. This role works very closely with the different stakeholders to successfully drive integration activities. This position represents the company as part of the overall company acquisition integration team and will interact heavily with our finance &...

As a Precision Medicine Planning Coordinator, you will plan and coordinate working providing oversight and project management related to our Precision Medicine and Clinical Laboratory Operations deliverables. This will support several clinical studies within a critical, fast-paced and high visibility clinical program. This role will support all functions within Precision Medicine, liaise with...

Drug Safety/Pharmacovigilance Specialist Pharmica is looking for a Pharmacovigilance Specialist to provide vendor oversight and case processing support. The position is based in the Princeton, NJ area but due to COVID, the work will be performed remotely, until the offices reopen in 2022. This person will be responsible for QC’ing vendor entries into the ArisG database, confirming that all cases...

Manager, Data Management   Position Summary: Maintain a project-level perspective on data management issues, activities and deliverables. Oversee the Contract Research Organization (CRO) and third-party vendor processes involved in developing data collection systems, data cleaning and providing data deliverables conforming to global CDISC standards. Provide strategic input into protocol design...

Description of Role Reporting to the Director/Associate Director of Device Development and Technology, Device Development Manager is the technical expert in the field of combination products & drug delivery devices who can effectively navigate and balance complex engineering, regulatory, quality and commercial needs while developing the best product for the user and patient. Primary expertise...

Materials Management Project Manager Our client is in the midst of enrolling over 100 materials through their vendor qualification/material enrollment process and are requiring support and oversight of this work. This project needs daily oversight, brain storming solutions with the project team, weekly dashboard maintenance, and driving tasks/process forward to ensure they have the materials...

Manager, Medical Information and Education (MI&E)Duties: • Write scientifically sound, and fair-balanced Medical Response Documents (MRDs) and conduct in-depth medical review of MRDs authored by others (Oncology therapeutic area). • conduct comprehensive literature searches across multiple databases and identify and analyze relevant data for inclusion in MRDs • manage MRDs through the...

Clinical Trial Manager III Duties: · Lead and manage integration of all project team activities, leveraging resources, expertise and knowledge, along with optimizing CRO resources to deliver the assigned clinical study on timelines, within budget and with acceptable quality. · Provide strategic input and execution of clinical trials from protocol design to the final clinical study report for...

R&D IT Project Manager - Regulatory The Research & Development (R&D) IT Project Manager will oversee the project(s) assigned to them developing and implementing IT tools that support the activities of the project team. The Project Manager has responsibility for the health and success of these projects within a matrixed organization that has direct relationships with various groups in the GSRS...

Senior Specialist, Quality Assurance - Clinical GMP Overview:  The Sr. Specialist of Quality Assurance, Clinical GMP will work within a phase appropriate system to provide quality oversight for clinical manufacturing and supply chain activities for clinical trial material. The position’s responsibilities span early-stage activities from Drug Candidate (DC) selection though all clinical phases...

This position will be responsible for managing projects assigned by the Director, IT RD-PDM as part of the Client's Research, Drug Development and PDM department. The role will be responsible for facilitating, directing, reporting and managing the implementation of specific projects such as Rave EDC, Study Builder, ClinPharm solutions and other assigned projects. This position will also manage key...

Our client is looking for a part-time remote CMC Project Management consultant. This consultant must be familiar with the following: • Understanding of overall CMC workflows and dependencies • Familiarity with Microsoft Project and/or SmartSheets • Ability to work semi-independently with CMC/manufacturing team and other stakeholders to synthesize information (timelines/read-outs) ...

Project Manager Consultant – ValGenesis and OSI PI Data Historian Integration with Instruments • Delivers project management support and oversight for the ValGenesis (computer system validation software) System and Data Historian (OSI PI) Projects, which involves the implementation of a ValGenesis system and OSI PI Data Historian application, and all other projects as needed by the business....

IT Project Manager Consultant – Veeva Quality Management System (QMS) • Delivers project management support and oversight for the Veeva QMS Program, with the initial implementation being CAPA/Deviations, and all other projects as needed by the business. This includes all work associated with the RFI and RFP processes, requirements definition, configuration, validation, cutover to production...

IT Project Manager Consultant – Veeva Regulatory Information Management System (RIM) and Clinical Data Management System (CDMS) • Delivers project management support and oversight for the Veeva RIM and Veeva CDMS projects, with the initial implementation being upgrading the existing Regulatory Information Management system and implementing a clinical data management system, and all other...

Project Manager: Global Regulatory Inspection Preparation We are seeking a Project Manager Consultant with experience working on global regulatory inspection preparation, readiness, and inspection support. Primary responsibilities will include project management expertise and support for one or more inspection preparation teams. Objectives are to ensure project plans are fully developed and...

GCP Quality Assurance Contractor We are seeking a GCP Quality Assurance Contractor (Assoc. Director Level) to support a fast-growing global specialty pharmaceutical company that discovers and develops novel oncology medicines. This is primarily a remote position; however, some onsite presence may be required, and it is preferred that the contractor be located on the East Coast or in the Central...

The Consultant Epidemiologist is a scientific role that involves supporting the development, coordination, and execution of cutting-edge, effective, and impactful research for rare disease epidemiology at a global level. The Consultant Epidemiologist will support the aHUS registry, especially analyses using registry data, and other hematology/nephrology indications. The Consultant Epidemiologist...

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,...

Summary: Serve as project management expert and provides professional services to global drug development programs. Manage clinical stage development projects and ensure projects are delivered on time, budget, and quality. Provide cross-organizational support to accomplish annual business plan goals. Essential Functions: • Budget Management: creation of accurate budget estimates, monitoring...

• Accountable for developing plan for Epidemiology deliverables (e.g. systematic literature reviews, database studies, analysis within primary observational studies / disease registries) within assigned therapeutic area to support company objectives. • Accountable for executing deliverables in accordance with the plan, either personally or through oversight of other Epidemiologists, or...

Drives development of the program execution team goals that enable the delivery of post approval clinical and commercial supply and commercial product lifecycle initiatives. Monitors and reports on progress of the program goals. Leads generation and alignment of a program specific Execution Plan across functional lines. Drives end to end program execution down to the task level to ensure...

Resource Management Project Manager Need someone to lead a project to develop structure and processes for a new resource management capability. Person needs to be solid project manager with very good knowledge of resource management, especially organizational structure, and key processes. Also needs good working knowledge of the pharmaceutical industry and how to develop timelines and resource...

Duties: • Participate in study team meeting, align with study details and collaborate in meeting study objective, Provide supporting information to the teams, in particular RA, RACMC, Clinical ops, and GPMs. • Design packaging requirements; based on a general understanding of the technical aspects of packaging in order to evaluate patient kit design and potential solutions to provide patient...

Essential Functions required for the job. List both technical and managerial requirements if applicable. • Manage PMO team calendar/inbox and individual calendars for PMO team • Manages PMO project workshops, events and meetings • Order and prepare session materials and AV equipment/support for project events • Book rooms and order food from internal and external catering for events...

Position Summary The Sr/Specialist, CMC Systems, Analytics and Reporting is key role in the CMC Program Management team that helps drive business decisions by analyzing data sets and reporting on metrics or key performance indicators at the program and portfolio level. The successful candidate possess critical thinking skills and the ability to understand and manipulate data to provide insights...

Clinical Outsourcing Specialist Primary person responsible for managing the process of obtaining external services to assist continued development of products as well providing supplemental support for other requirements within the organization. • Manage study/program specific clinical outsourcing, vendor sourcing, vendor selection/award process, and negotiation of contract terms in complianc...

Project Manager will be responsible for leading complex cross functional projects as well as managing the department's overall portfolio of projects. Responsibilities Include: • Define project scope, goals and deliverables • Create project charters • Define tasks and required resources • Develop and manage project budgets • Allocate project resources • Create schedule and project...

This position is responsible for managing program development, delivery, project management, assessment, and event management for more than 20 initial projects.  As part of the grant program, this role manages various activities necessary for the grant program's success including events that increase the quality of proposals the client receives as well as events that highlight its impact. ...

1. Summary of Purpose:   SAS programming support for ongoing and planned clinical trials analysis and reporting for 2021/2022.   2. Deliverable Overview The specific duties assigned to the Clinical Programmer Contractor are as follows: - Independently develop/validate programs that generate SDTM and analysis datasets based on ADaM specifications - Prepare/QC ADaM datasets documentation:...

Resource Management Project Manager This is a resource management project manager role. The resource management project manager is responsible for the planning, management and execution of Intrinsic projects for clients as well as liaising with IT for technical tasks for clients and internally. The position works closely with ICS clients, architects, developers, testers and the project team to...

Job Description Pharmica Consulting has several leadership roles in drug development project management. The consultant will act as an associate director, director or senior director of drug development project management and work cross functionally managing an asset with no direct reports. The senior leader ensures that concurrence between the team and management is achieved for program...

Global Medical Affairs - Publication Manager II   Duties: • GMA Publications Manager will help develop, deliver, and drive the execution of internal and external scientific communication strategy and related tactics including global publications (e.g., abstracts, posters, manuscripts) and scientific materials • Support standardization across the geographies • Work with agency partners...

Position Summary The Senior Safety Scientist plays a leadership role within Global Drug Safety organizing and mentoring safety scientists to actively evaluate, manage and strategize risk in collaboration with the GDS Medical Directors and cross-functional team members within the global regulatory framework Job Duties & Responsibilities • Proven skill set for strategic leadership in a cross...

The Program Manager serves as a key driver on 2 or more development programs focused on strategic planning and oversight of operational execution. In this role, the Program Manager ensures team and Sr. Management alignment on program objectives, deliverables and timelines to support the organization’s overall goals; works with teams and management to create the development strategy, establish...

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...