Drug Safety Associate (Remote) We are seeking a Drug Safety Associate to support the Pharmacovigilance group at our client in Palo Alto, CA. This is a full-time, 6-month contract position that can be performed remotely from anywhere in the United States. Job Description: • Responsible for performing a wide variety of tasks related to drug safety. • In charge of reviewing and evaluating...

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...

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

Project Manager- Drug Development and Manufacturing The Project Manager partners with the Project Lead to successfully shape and execute the project and drug development strategies in development and manufacturing. The Project Manager is accountable for the cross-functional planning and execution of one or more programs including definition of the operational strategy, management of timelines,...

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...

We are seeking a Procurement Specialist to work as an integral member of the NA Business Operations team, managing the processes associated with purchase requisitions and vendor agreements. Responsibilities will include reviewing all submissions in detail for accuracy and completeness, partnering with internal stakeholders such as Legal, Procurement and Finance, processing agreements and...

Description: The Business Contract Operations Specialist will work as an integral member of the NA Business Operations team, managing the processes associated with creating vendor agreements, including service agreements, work orders, change orders and purchase requisitions. Responsibilities will include reviewing all submissions in detail for accuracy and completeness, partnering with internal...

Client is looking for a Clinical Quality Systems Project Manager to join the Quality Scaled and Digital Services team. 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. Principal Responsibiliti...

The Global Medical Affairs Project Manager will provide support to strategy, operations, and will be responsible for project management. The Project Manager directly reports to Global Head of Medical Affairs Excellence The Project Manager will work closely with Medical Directors and provide feedback to relevant Therapeutic Area Heads regularly, which she/he has assigned in, about daily...

Position Summary Client’s Global Product Development organization is seeking an experienced synthetic organic chemist to establish our process development capability in solid phase peptide synthesis (SPPS). The Associate II, Solid Phase Peptide Synthesis will serve as the subject matter expert for SPPS within Client. Responsibilities include delivering a comprehensive strategy for the...

Position Summary The CMC/R&D Operations Program Manager(OPM) is the 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(s). The OPM provides global program management support to the Operations Asset Team(s) (OAT) in Global Operations, implementing industry-leading Program Management...

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...

The Scientist II is a highly motivated, innovative, and data-driven Medicinal Chemist with broad drug discovery experience and strong technical and problem-solving skills in Organic and Medicinal Chemistry. The successful candidate will join the Medicinal Chemistry team and collaborate in the discovery of high quality drug candidates, provide technical leadership in a flexible, cross-functional...

Position Summary:   Provides strategic regulatory expertise and leadership for global and regional health authority interactions and submissions. Ensures development of drugs are in accordance with global regulations, optimizes the label and obtains shortest time to approval by regulatory agencies. Represents client in key interactions with regulatory agencies and ensures successful negotiatio...

Strong Project Manager needed to track and oversee medical communications slide deck development. Interpersonal skills are critical for helping coordinate content acquisition internally. The ideal candidate will have some understanding/experience with scientific communication decks. Responsibilities: -Utilize project management principles to ensure projects are flawlessly executed. -Provide...

Description: Looking for someone based in East Coast to support EST time zone. The Consultant Medical Safety Physician, Drug Safety, will be responsible, as required, for medical review of individual case safety reports, performing aggregate safety data review and safety surveillance activities for potential safety signals, and review and assurance of medical/pharmacovigilance content and...

Research Project Manager Pharmica is seeking an experienced Research Project Manager to manage novel therapeutic drug development projects from late-stage discovery through IND. In this key role, the Project Manager will manage teams of researchers, consultants, and contractors to facilitate smooth delivery of agreed project plans within time and budget constraints, advancing projects from...

The Regulatory Submissions Project Manager (RSPM) will manage projects involving submission of regulatory applications, such as NDAs and MAAs. This individual will partner with the submissions team leader to manage business deliverables associated with each assigned project and ensure compliance and on-time delivery. The RSPM is accountable for developing and maintaining overall project...

Early Phase Drug Development - Senior Level Project Manager The Project Manager partners with the Development Program Lead (DPL) to lead the Development Program Team (DPT) to successfully shape and execute the project and drug development strategies, in early development. The Project Manager is accountable for the cross-functional planning and execution of one or more programs including...

The Drug Development Project Manager is a key member of the client organization and will partner with internal team leads to provide leadership, management, and oversight of global drug development programs. The ideal candidate is one who is experienced in drug development, has a demonstrated track record of managing cross-functional development teams across the product lifecycle, and understand...

This individual is responsible for working the end-to-end strategic sourcing processes, from analysis through negotiating, and contracting. In addition, he/she would recommend appropriate strategies and tactics to obtain desired results. This position will also work with the vendor management group and Requestors of Service (ROS) who manage the vendor relationships. Responsibilities: Develop...

Position Summary: Scientific function responsible to support a global pharmacovigilance system (both development and post marketing). Scientific functions includes but not limited to signal detection, risk assessment and management, Risk Management Plan (RMP) development, aggregate safety reporting, and clinical safety surveillance.   Key Job Responsibilities: Ensure that the benefit...

Job Description: We are seeking an experienced, well organized professional who will develop, implement and manage RWD and Observational Research (OR) strategies and tactics to demonstrate the value of pipeline and inline products in HIV/AIDS. The role of Real World Data (RWD) has greatly expanded and has been recognized to providing value to determine comparative effectiveness, longer-term...

The Sr. Project Manager is part of the Global IT Portfolio Management & Governance organization. The Sr. Project Manager is accountable for partnering and delivering across multiple patient services projects on time, within budget, and with high quality. This position focuses on projects within the Patient Services team and will provide overall project management including management of scope,...

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...

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...

Senior Project Manager, Business Process Specific Responsibilities: The Systems and Process (S&P) team is a dedicated, centralized group that provides strategic consultation, technical consultation, and internal customer service for our client's Development Operations team. The team promotes excellence in standards, processes, analytics, and business intelligence for the benefit of our...

Project Manager, External Biologics Manufacturing Position Summary The Project Manager will be responsible for supporting Technology Transfer teams, on several biologic drug substance and drug product external manufacturing projects of different clinical phases. The Project Manager interfaces directly with Contract Manufacturing Organizations (CMO) and works with the project teams’ members 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...

Duties: Serve as lead CDM on 2 registry studies Attend internal and external study team meetings Responsible for the study-specific data management tasks from protocol review to database lock to ensure data are collected, reviewed, and delivered with high quality, on-time, and within scope. Responsible for the managing the EDC database migration activities including obtaining update...