Position Summary The Culture Project Coordinator will be responsible for partnering with the Head of Culture to shape and build a culture that enables our business strategy and commitment to patients and makes the client the most rewarding company to work for. This position reports directly to the Head of Culture. Principal Responsibilities Provide project coordination/management, administr...

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...

Associate Director, Translational Medicine Team Leader Summary: Gossamer Bio is seeking a Translational Medicine Team Leader who will be responsible for developing and executing translational strategies for assets in early stage development for the pipeline. The TMTL is be a key interface within the Translational Medicine team, and provide an overall accountability for TM strategy and...

Sr Director, Translational Medicine Team Leader Summary Gossamer Bio is seeking a Translational Medicine Team Leader who will be responsible for developing and executing translational strategies for assets in early to late stage development for the pipeline. The TMTL is be a key interface within the Translational Medicine team, and provide an overall accountability for TM strategy and...

Position Summary 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...

Position Summary 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....

· Leads preparation, review, and update of content for the development and maintenance of Core, US, EU and Canadian labeling and packaging components · Demonstrate a high-level understanding of labeling content requirements, regulations and guidance to guide labeling teams and support labeling strategies · Develop and maintain Target Product Profile, Company Core Data Sheet (CCDS) and local...

Specific Responsibilities: The Systems and Process (S&P) group is a dedicated, centralized team that provides strategic consultation, technical consultation, and internal customer service for the company's Development Organization. The team promotes excellence in standards, processes, analytics, and business intelligence for the benefit of the company and patients everywhere. This position...

Pharmica Consulting seeks a Promotional review/medical PRC reviewer to support our client in the Princeton, NJ area. This is a position requiring 40 hour/week and potential on-site presence, after their facilities reopen.          Experience and Knowledge: Reviewing claims within promotional materials for medical accuracy and completeness OPDP guidelines and understanding of the promotiona...

Pharmica seeks a Case Processing Associate to support our client in the Princeton, NJ area. This is a position requiring a 40 hour/week and potential on-site presence, after their facilities reopen. This position is responsible for processing incoming AE information, including:   Case review, QC of safety data in ARGUS, data cleaning for previous cases in ARGUS, performing literature...

Position Summary & Scope This position will be responsible for gathering Quality metrics, analyzing, trending and developing presentation content for all locations and Quality Management Reviews to evaluate performance, risks and alignment with current expectations. Metrics and Reporting Manager will also serve as a cross-functional lead and/or project manager for key initiatives resulting from...

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...

Role Description – Sr. Associate Compliance Auditing and Monitoring This position will assist E&C's Healthcare Law Auditing and Monitoring function supporting the Chief Compliance Officer in executing an effective compliance program. The Senior Compliance Auditor will assist the Manager, Healthcare Law Auditing & Monitoring and others to execute the annual plan by conducting audits and other...

We are currently searching for a skilled Medical Affairs professional to join our client as a Senior Manager, Global Medical Affairs, Nephrology. The Senior Manager will be responsible for overseeing and assisting with nephrology projects, in alignment with the Global Medical Affairs Department goals and initiatives. Project work will span from early to late-stage and commercialized programs. ...

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

-Provide help with managing key activities to develop budget based on study design – protocol is written -Work with client on two INDs -Develop timelines for two clinical programs -Figure out timing of clinical supplies -Keep trains on track and keep track of all workstreams -Help “tell the story” for series A investors – show plan for executing on studies and programs -Look for blind...

Pharmica seeks aPV Quality & Compliance Manager to support our client in the Basking Ridge, NJ. This is a 6-month contract position requiring 40 hour/week and potential on-site presence, after they reopen their facilities. Duties:This position supports the head of CSPV Quality and Compliance in the establishment, implementation and oversight of the CSPV Quality, Compliance and Training function...

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...

Quality Associate - CW, Global Product Quality R&D 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 company and GMP requirements. Reviews and approves analytical test results/raw data to ensure...

Senior Manager, Pharmacovigilance & Epidemiology The Senior Manager, Pharmacovigilance & Epidemiology is responsible for or supports various pharmacovigilance and risk management/minimization activities for investigational and marketed products Responsibilities (include but are not limited to): • Support preparation and maintenance of Risk Management plans • Contributes to development and...

Job Description for Global Quality Solutions Representative  Responsibilities include but are not limited to: Partner with and support assigned functional groups, departments and regions to achieve the goals and objectives of the Global Quality Team Interact with the various business groups within the Global Quality team and supports their technology needs by partnering with IT to implement...

Clinical Product Quality Complaints Investigator Responsible for receiving and handling (documentation, coordination, investigation, resolution and closeout) of all Clinical Product Quality Complaints for drug products/medical devices/combination products in a manner that complies with regulatory requirements (21CFR Parts 210, 211, 820). Follow-ups with CROs, clinical sites, CSO and...

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/objectives without compromising project deliverables or quality ...

Veeva Implementation Project Manager Delivers project management support and oversight for the Veeva project. This includes the all work associated with requirements definition, configuration, validation, cutover to production through hyper-care activities. Manage the delivery of any open defects, integration work, and/or requested enhancements post launch within the timeline established. ...

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...

Statement of Work An experienced Program Lead/Manager will be able to develop, organize, direct, and coordinate the Clinical Trial Data Transparency program. The CW will is expected to provide strategic guidance to functional lead and cross-functional business partners (where applicable). CW will manage several initiatives in ways that lays the path of program success. The Candidate will be...

Key Words/Experiences: Program Lead, Supply Planning & Logistics: Drug Supply Forecasting Logistics Scheduling Packaging Labeling Process Facilitation Oncology Program Lead, Supply Planning & Logistics Duties:This position is responsible for the on-time delivery of clinical supplies for both medium and high complexity programs with significant technical and geographic complexity...

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...

The CSV Auditor will provide expert advice and hands on capabilities to various types of audits that includes, but are not limited to, supplier audits, computerized systems audits, process audits and data integrity audits in the regulated pharmaceutical and medical device industry. Significant travel in excess of 50% is expected 1.Contribute to and perform all CSV audit activities including...

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 companies Quality System, inspection management, regulatory intelligence activities, SOP and WP management, validation activities, and project liaison activities.Significant travel in excess of 50% is expected 1. Pharmacovigilance ...

Job Description This position is responsible for providing troubleshooting guidance for analytical testing conducted by CMOs for small molecule candidates and raw materials; oversee impurity characterization and control strategy setting; evaluate degradation pathways; oversee reference standards qualification and management; and author/review CMC sections for IND and NDA filings for the small...

Summary Responsible for ensuring continuous product supply while minimizing EEO. Work with commercial/clinical teams and clinical supply managers to ensure alignment of drug substance and drug product demand and supply plans across Global Supply Chain for the Asset. Ensure metrics are in place to drive achievement of team objectives. Work with Asset Team to ensure processes are in place to...

Position Summary Manages the efficient flow of goods, services, and information throughout the clinical supply chain, including product order management and global distribution. Builds relationships with and acts as a key resource and escalation point for internal customers, distributors, and suppliers. Contributes to the creation of strategy for clinical drug supply; translates strategic...

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,...