Position Summary The Clinical Project Lead is responsible for 1) strategic oversight and operational accountability of a financially robust clinical development program and/or 2) direct report management of resources (e.g., Clinical Project Leads). The Director may be a member of the program’s Core Team and as such, will ensure alignment and accountability with other Clinical Development...

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...

Position Summary Supports the CPLs and CTMs for business administrative tasks, especially for trial master file creation, maintenance, closure, and transfer for a single product and multiple studies per company or CRO SOPs. Handles centralized business process tasks, e.g., CDA generation, submission of insurance documentation, safety letter tracking, CSR appendix generation, patient safety cards...

Position Summary The Clinical Project Lead is accountable for the study team and study deliverables and is the primary point of contact interfacing between functional groups, investigator sites and vendors. The CPL will drive the scope of work, oversee CROs and will proactively manage patient safety and data integrity to ensure inspection readiness and compliance. The CPL will provide status...

The Project Coordinator is a role to support administrative/data maintenance duties within the Strategy, Portfolio, & Program Management (SPPM) department. The role may support a Program Manager (PM) or SPPM Therapeutic Area (TA) Lead Schedule meetings, collate meeting materials, and assist with drafting meeting minutes Per PM instructions: Create/update a schedule/timeline Follow up...

Project & Strategic Initiatives Coordinator supports Project & Portfolio Management (SPPM) in both project and strategic initiatives management and execution. Works closely with SPPM leadership on projects and strategic initiatives, providing technical/administrative PM support through in depth project/task knowledge, follow up on action items and assists in up to date maintenance of project...

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 business partners; Supporting Service...

Associate Director, Project Management We are looking for an Associate Director, Project Manager to support a fast growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and develop novel medicines in four areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders. This is a contract position and we are open to remote...

Position summary: R&D Strategic Outsourcing aspires at leveraging supplier market intelligence and competitive landscape to develop and execute optimal outsourcing strategies in collaboration with key stakeholders, that enable speed, quality, business transformation, and efficiencies to increase the probability of success. This position leverages agile category management best practice in close...

Position summary: R&D Strategic Outsourcing aspires at leveraging supplier market intelligence and competitive landscape to develop and execute optimal outsourcing strategies in collaboration with key stakeholders, that enable speed, quality, business transformation, and efficiencies to increase the probability of success. This position leverages agile category management best practice in close...

The Portfolio Analyst is an individual contributor on projects and is responsible for producing high-quality portfolio level reports, quality checking data and supporting the Portfolio Management director on projects. Job Responsibilities: • Data cleaning and updating portfolio level meta data to enhance our data analytics • Producing high quality monthly reports for senior leadership...

Position Summary The Principal Oversight Clinical Data Manager (PCDM) has a keen attention for detail and is responsible for overseeing the data management start-up and execution of several fully outsourced trials to ensure data quality and integrity. PCDMs will independently lead multiple, high volume and extremely complex studies across multiple development programs. The individual will perform...

This role will interface globally with users across Global Operations, Commercial, Research & Development, IT and Quality to support execution and monitoring of the enterprise Quality Management System (QMS) governing Deviation, CAPA and Change Control. Role can be onsite or remote, supporting US East Coast business hours. Principal Responsibilities: • Use deep process knowledge and experienc...

The consultant will be accountable for leading key strategic global operational excellence activities across Research & Development (R&D) functions and regions, including integration of Business Development and Licensing (BD&L) activities, process improvement projects, and quality initiatives. Leads cross-functional assigned project workstream(s) to successfully deliver new process, systems and...

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 Client standards. Provide strategic input into protocol design...

Commercial Strategy Project Manager Responsibilities • Supports the project teams toward implementation of the strategic and operational plans and tracks progress to goals. • Manages and tracks program progress as assigned on a continual basis, identifying and tracking both cross-project and cross-functional risks and issues related to scope, timelines and budget. As appropriate, informs...

PROJECT MANAGER - LAUNCH TEAMS The Project Manager – Launch Teams reports to the Director of Business Unit Operations and will be a member of two launch teams: one a geographic expansion for our approved biologic drug product; the second a fast-track potential launch of a novel therapy for a critical medical need. On a regular basis, the Project Manager – Launch Teams will collaborate with the...

This position will be a member of the GxP Rapid Response team initiatives for Central Quality System and Compliance. The Quality Support Lead will also serve as a cross-functional member for key initiatives in Central Quality Systems and Compliance. The Quality Support Lead is responsible for maintaining and improving Quality System processes to ensure quality initiatives are completed and...

The Strategy & Program Management Group’s (SPM) primary objective is to achieve and maintain sustainable growth by maximizing value and prioritizing resources across the Client portfolio. The Consultant, SPM will play a critical role in driving Client’s success by contributing to this objective. The consultant will be integral to executing on Client’s algorithm and approach to balancing opportunit...

Drug Development Project Manager Job Description The IT Project Manager acts as a central contact for business needs that can be solved using the SharePoint, Power Apps and Power Automate. The project manager will be responsible for client interaction, collecting requirements, prototyping/building/testing solutions and demonstrating the solutions to clients to received feedback and iterate on...

Duties: • Scientific Communications Specialist II will provide support to the Director, Scientific Communications, for the development and execution of the global communications strategy, publications plan and medical education initiatives for the assigned therapeutic area franchise and product. • The Specialist is responsible for managing tactical publications plans and activities,...

Early Phase Drug Development - Senior Level Project Manager 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 objectives and meets these objectives to achieve...

Position Summary  The Sr. Specialist for QA External Manufacturing will be responsible for providing oversight of quality activities associated with drug substance, drug product, devices and finished product manufacturing processes at contract manufacturing organizations. The Sr. Specialist contributes and supports the completion of milestones associated with specific projects and supports...

Responsibilities: • Work as a GQM representative- assigned clinical studies and is responsible for developing and maintaining good relationships with other FAs such that it will foster positive interactions and ultimately support achieving desired outcomes • Perform remote and onsite (as applicable) GCP audits on External Service Providers/Vendors/CROs along with CSV audit co-auditors •...

The Medical Communications Excellence team, an integral part of Global Medical Communications, works to drive strategic, aligned and compelling medical communications across Global Medical Affairs based on best-in-class training, materials and tools, leading on Global Medical Training, Strategic Communications and Digital Innovation. The Project Manager, Medical Communications Excellence will be...

Position Summary Serving as a link among key functions, the Manager, Medical Writing ensures that critical scientific information is communicated with clarity, precision, and accessibility. This position will work cross-functionally with therapeutic teams, including Clinical, Commercial, Marketing, Communications, Regulatory, and Legal, to prepare manuscripts, abstracts, reviews, posters, reports...

Position Summary Reporting to the Director/Associate Director of Device Development and Technology, Device Manager, Human Factors is the technical expert in the field of human factors as it relates to combination products, drug delivery devices and healthcare apps. This position will manage all aspects of human factors in order to develop safe and effective systems for use by patients or...

Good Vigilance Practice (GVP) Auditor The GPV Auditor will lead and perform audits with a focus on Pharmacovigilance activities. Additional tasks are required to support the continuous improvement of the Quality System, inspection management, regulatory intelligence activities, SOP and WP management, validation activities, and project liaison activities.   1. Pharmacovigilance Audits •...

Provides leadership and day-to-day guidance to internal and External Service Provider (ESP) project team for the GMP related documentation and enquires within an assigned products and projects. Ensures timely review and approval of batch records documentation and associated quality records. Collaborates with affiliates, ESP personnel, and OPDC/OAPI internal project teams to assure commercial...

Drug Development Project Manager(Remote) The Project Manager role in Global Portfolio & Program Strategy provides an opportunity to contribute to development and commercialization of innovative cell therapies for the treatment of cancer. The Project Manager works in collaboration with the Product Team Lead, Global Program Lead, and Product Team Members to plan and facilitate cross-functional team...

Description: Provides leadership and day-to-day guidance to internal and External Service Provider (ESP) study team for all protocols within an assigned program. Ensures cross-study consistency in protocol design, data analysis and reporting. Interacts with expert physicians, investigators, ESP personnel, and functional area staff to ensure program strategy and objectives are understood and...

Program manager, CMC Program Management is the key program/project and operational excellence leader for the Global CMC Program and Operations Management group for all early and late stage development assets. He/she provides global program management support to the CMC Sub-team, driving industry-leading PM best-practices to align cross-functional stakeholders. He/she is responsible for management...

Responsibilities Include: • Manage large project involving pharmaceutical records/document management • 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 • Follow up with stakeholders to ensure deliverables are being...

We are looking for an innovative, highly motivated Research Project Manager with a strong scientific background in preclinical drug discovery research and project management. The ideal candidate has a proven ability to manage internal research and drug discovery project teams and drive results forward. Responsibilities include the use of best practices for planning and tracking early to late-stage...

Job Description: The Sr. Medical Writer (Chemistry, Manufacturing & Controls [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. He/she will manage processes intended to increase project efficiency,...

Description: The consultant will have the overall medical safety responsibility for client product(s). This individual will lead completion of key safety related documents including IBs, safety aggregate reports, regulatory queries, safety sections of study reports and ISS’. This individual will also ensure the assessment of individual case reports, narratives and coding as well as lead the cross...

This position will serve the role of Device Engineer III for device development of Client products including continuous product improvement within the Development function of Client. The candidate will support design control deliverables and quality compliance for device and combination products.  Principal Responsibilities • Drive design control activities and deliverables and manage...

Global Regulatory Affairs Project Coordinator   • Drive Global Regulatory Affairs projects and process improvement activities • Actively engage and collaborate with the Global Regulatory Affairs Project Coordination and Compliance Lead and other GRA leaders to achieve the goals set out in the department • Employ solutions to enhance processes, technologies, and activities • Lead...

Description: • End-to-end planning, coordination, and execution of major applications/submissions such as supplementary New Drug Applications (sNDAs) and Marketing Authorisation Applications (MAAs) under the guidance of the Global Program Manager for the asset development program • Support the Client Oncology teams in obtaining internal agreements and buy-in on all aspects of the submission...

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...

Client's Global Product Development organization is seeking an experienced technical professional to expand our solid oral dosage development capabilities in support of an emerging small molecule portfolio. The Associate II, Small Molecule Drug Product Development will couple strong laboratory skills with experience in formulation design, equipment selection, and process scale-up. Job Duties &...

Description: • Leads and performs risk-based validation of GxP systems, develops validation documents using defined CSV process, and communicates project progress throughout the system lifecycle. • Validates system implementations, system upgrades and creates system documentation in accordance with computerized system validation plan and protocols. Deliverables will include Validation Plan,...

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...

Position Summary This role is responsible for driving local and enterprise culture transformation efforts and providing strategic guidance to senior leadership. This highly impactful role is one of leadership and partnership across the enterprise. S/he is a valuable thought leader who will enable Client to achieve its corporate objectives, long-term strategy, and ambition of becoming the most...

The Solution Architect will be responsible for development and technical support of commercial applications - Veeva CRM, Salesforce Service Cloud (Case Management application) and Veeva Vaults (PromoMats and Medcomms for content management & distribution). This person will report to Senior Director, Commercial Applications at New Haven, CT. The ideal candidate will bring hands-on technical...

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,...

We are looking for an individual to work closely with multiple stakeholder groups to plan, develop, update, and control schedules for clinical studies using Microsoft Project in a MS-Project Server environment. On a typical day you might: • Obtain activity status from stakeholders to update and maintain an accurate schedule. • Develop new schedules using a template to identify what is to be...

Biomarker Sample Operation Project Manager, Translational Medicine Summary As a Biomarker Sample Operation Project Manager in our Translational Medicine team, you will be responsible for the oversight of clinical trial biomarker sample testing according to the schedule of events with clinical CRO and multiple bioassay vendors. This position offers the rewarding opportunity to do work that...

Project Change Manager • Prosci Certification is a plus • Project management of projects involving process changes, including change management elements • Enable operational excellence by utilizing project management tools (timelines, minutes, agendas, risk management, etc) and practices to ensure project success • Works independently to drive execution of projects to achieve goals/objec...

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...