15 jobs found

Proclinical is seeking a remote Associate Director, QA Processes and Systems for a leading biotech company. Must be eligible to work or be a citizen in the US. Job Responsibility: Supports the setup and maintenance of the Global Development Quality Management System (clinical QMS). Ensures the implementation and maintenance of processes for Procedural Document Management, Training/Learning Management System and Management of GCP Deviations, including Serious Breaches. Supports the implementation and maintenance of processes for Clinical Risk Management, Health Authority Inspection Management and Regulatory Intelligence. Supports cross-functional enterprise level projects, systems & teams and act as a credible and respected spokesperson on matters pertaining to QMS and management of procedural documents, training and deviations. Assumes responsibility for performance results and establish & monitor Quality Objectives and Metrics. Promotes a pro-active risk-based...

Proclinical is seeking a remote Director Medical Writing for a top biotech company. This position will be a member of the Medical Writing Leadership team and actively contribute to driving the overall strategy and identifying development areas within Medical Writing to ensure that the Medical Writing group works toward the same objectives and as one team. Must be eligible to work or be a citizen in the US. Skills and Requirements: Minimum of 12 years' relevant medical or scientific writing experience in the Pharmaceutical Industry (oncology experience preferred) Have prior people-management experience Strong analytical skills High quality standards Committed to meeting deadlines Essential that you are well-organized, proactive, and flexible, and have the ability to work on multiple complex tasks simultaneously. If you are having difficulty in applying or if you have any questions, please contact Merna Hermiz at (+1) 323-306-2409 or m.hermiz@proclinical.com....

Proclinical is seeking a remote Information Specialist for a top pharmaceutical company. Must be eligible to work or be a citizen in the US. Job Responsibility: Accurate and timely registration of adverse event report from initial receipt to data entry within required timeframes. Performing Quality Review of external provider's reconciliation tasks for Clinical and Post-marketing (Medical Information, Product Complaints and third-party vendor) cases. Clearly and succinctly communicates information to customers verbally and in writing. Demonstrates a high level of customer service to both internal and external customers. Utilizes judgment skills to identify issues that impact the workflow. Skills and Requirements: High school diploma required. Associate degree or bachelor's degree preferred - 6 months to 1 year of similar work experience. Medical terminology knowledge preferred and prior experience in a regulatory / medical setting If you are having difficulty in...

Proclinical is seeking a remote Senior Manager, QA Processes and Systems for a leading biotech company. Must be eligible to work or be a citizen in the US. Job Responsibility: Supports the execution and maintenance of the Global Development Quality Management System (clinical QMS). Supports the implementation and maintenance of one or more of the following processes/systems: Procedural Document Management, Training/Learning Management System, Management of GCP Deviations (including Serious Breaches), Management of Health Authority Inspections, Clinical Risk Management and/or Regulatory Intelligence. Supports cross-functional enterprise level projects, systems & teams and act as a credible and respected spokesperson on matters pertaining to QMS and management of procedural documents, training and deviations. Assumes responsibility for performance results and monitor Quality Objectives and Metrics. Promotes a pro-active risk-based Quality culture by leveraging Quality...

Proclinical is seeking a remote Director, Publishing and Submission Management for a leading pharmaceutical company. This position will develop and apply a comprehensive understanding of global RA regulations and guidelines on different submission types/formats (NeeS, eCTD, Paper, ACTD, eCopy, IMPD, PIP, DMF, ASMF etc.) to projects to enhance probability of regulatory success and regulatory compliance. Must be eligible to work or be a citizen in the US. Job Responsibility: You will partner with project management and functional areas to develop strategic plans for health authority submissions and interactions. You will also monitor global health authority regulations, guidelines, and specifications in- markets such as US, EU, EMEA, Canada, AU, CH, GCC, EAEU and APAC for regulatory submissions to ensure compliance. Offer expertise and guidance to Regulatory Strategy and key stakeholders to support regulatory submissions with global health authorities. Work with other...

Proclinical is seeking a remote Social Excellence Project Coordinator for a leading biopharmaceutical company. Must be eligible to work or be a citizen in the US. Job Responsibility: Work closely with global/regional/local Medical Affairs and Analytics teams to develop and execute an effective, scalable social listening engagement strategy Deliver social listening reports to inform medical strategy around congresses and key events Optimize the utilization of social media listening tools to drive innovation in reporting and insights Support medical teams with incorporating outputs into engagement plans Act as the primary contact for the social listening platform vendor(s) translating medical needs into actionable data and insights Ensure oversight, project management and delivery of social listening projects, setting milestones and digital KPIs to monitor medical impact and value. Skills and Requirements: Bachelor's degree in science or business required...

Proclinical is seeking a remote Quality Systems & Compliance Manager for a top biotech company. Job Responsibility: Manage the GxP Vendor and Audit programs. Provide business administration, management, and user support within the Veeva QualityDocs and eQMS to GxP users. Ensure qualifications and training for auditors is complete and documented. Skills and Requirements: B.S degree in life sciences, chemistry with a minimum of 10 years of experience of quality management system experience with progressive responsibility in a lead or managerial capacity. Extensive knowledge of GxP and Quality principles, practices, and standards Strong knowledge of global regulations (EU, US) If you are having difficulty in applying or if you have any questions, please contact Kelly Guerriero at (+1) 267-281-1277 or k.guerriero@proclinical.com. Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical,...

Proclinical is seeking a remote Clinical Application Specialist II for a top pharmaceutical company. This position will provide support to the Global Epidemiology group in Pharmacovigilance & Patient Safety. Must be eligible to work or be a citizen in the US. Job Responsibility: Contribute to the design and execution of pharmacoepidemiologic studies including those using large insurance claims and electronic health records databases, support characterization of descriptive epidemiology for diseases and indications, contribute to regulatory submissions and responses, and perform literature reviews on topics required for ongoing support and/or development of drugs and devices. Skills and Requirements: MPH or MS with more than 2 years of experience or PhD/MD/PharmD. with experience in the field of epidemiology, outcomes research or related discipline. Demonstrated experience in managing large studies or projects. Understanding of epidemiology methods and study...

Proclinical is seeking a remote Project Manager - Restricted Substances for a top pharmaceutical company. Must be eligible to work or be a citizen in the US. Job Responsibility: Interacts internally, across multiple functional areas, and externally to obtain annual volumes of purchased- and manufactured substances. Data must be well-organized, with long-term retrieval capabilities. Reviews and analyzes component and sub-assembly information, assessing for restricted substances impact Reviews and analyzes site chemical inventory and maintains inventory accuracy. Ensures RSM compliance is considered as part of long-term and short-term planning, including lifecycle management and new product introduction Skills and Requirements: Excellent communication skills Self-starter able to work with minimal supervision; results oriented; strong workload organization- and problem-solving skills Database management Competency with Microsoft software suite (e.g. PowerPoint, MS...

Proclinical is seeking a remote Principal Medical Writer for a leading pharmaceutical company. Must be eligible to work or be a citizen in the US. Job Responsibility: Responsible for formulating writing strategy as well as developing clinical and regulatory documentation. Comfortable representing medical writing cross-functionally with other members of the organization . Report into the Medical Writing Team Lead that oversees an entire therapeutic area. Assist them with the coordination of medical writing activities between internal employees, contract employees, and vendors (on-site and off-site). Responsible for individually contributing high quality regulatory/clinical documentation according to all guidelines and timelines. Skills and Requirements: Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor's degree is required. At least 7 years of experience writing clinical/regulatory documents for a pharmaceutical or...

Proclinical is seeking a remote LMS Deployment Lead for a leading biopharmaceutical company. Must be eligible to work or be a citizen in the US. Job Responsibility: End to end delivery and adoption of Saba Cloud Ensure timely execution of training, communications, and change management Oversee training Redesign and communicate with HR Ensure plans and strategy documents (change, communications, and training) are developed, maintained, and executed throughout project lifecycle Coordinate with Core Team members and Project Leads to consume plans /strategy documentation and align/ensure alignment with overarching deployment strategy Work with the technology teams, engagement lead, project manager and core team Managing deployment related blockers, risks and issues to ensure smooth delivery Measuring the quality and efficiency of the system adoption post migration Skills and Requirements: Bachelor's degree, master's preferred Project experience, Project Management...

Proclinical is seeking a remote LMS Organizational Designer for a top biopharmaceutical company. Must be eligible to work or be a citizen in the US. Job Responsibility: Partner with HRH Deployment Team on SumTotal to SABA change, comms, and training activities. Partner with business stakeholders to agree on adoption and implementation plans bringing them in line with the T&D technology and operating model. Managing demand from the business areas, in terms of readiness needs - work with the technology teams, engagement lead, project manager and core team to agree the overall implementation plan for Partner with HRH Deployment Team on SumTotal to SABA change, comms, and training activities. Partner with business stakeholders to agree on adoption and implementation plans bringing them in line with the T&D technology and operating model. Managing demand from the business areas, in terms of readiness needs - work with the technology teams, engagement lead, project...

Proclinical is seeking a remote LMS Training Manager for a top biopharmaceutical company. Must be eligible to work or be a citizen in the US. Job Responsibility: Ensuring that all training audiences, requirements, and needs are identified, training is developed and/or curated, and successfully deployed in alignment and within a timeline Develop a working knowledge ad current list of Learning Content Owners, their functions and an understanding of their training needs associated with the SumTotal to SABA migration Partnering with a Technical Lead and designated Learning Content Owners Develop training objectives associated with each training audience Development and/or curate training content, including job aids, process documentation, and any supporting tools Partnering with the Change/Communications Lead, develop a training communication plan Participate in users acceptance testing and prepare to address/respond to unidentified training needs Actively participate in...

Proclinical is seeking a remote Regulatory Technical Writer for a global biotech and pharmaceutical company. Must be eligible to work or be a citizen in the US. Job Responsibility: Support BLA/MAA/ROW (emerging markets) expansion effort for a biologics project, including compilation of market-specific requirements and leading information request response preparation Track submission activities and change controls for RACMC and ensure visibility to cross-functional CMC stakeholders Assist with ongoing GXP systems transition, related to change control and regulatory dossiers Ad hoc RACMC support to line manager Assist with post-approval and investigational life cycle management as needed, including but not limited to post approval supplements and variations, annual reports, and investigational (IND/IMPD) amendments, per team and program timelines. The outlined tasks may be subject to change as the workload of the business requires Skills and Requirements: Experience...

Proclinical is seeking a remote Recruiting Coordinator for a top biopharmaceutical company. Must be eligible to work or be a citizen in the US. Job Responsibility: The University Relations Recruitment Coordinator is responsible for developing and maintaining University, College, and professional organization partnerships. They will also be responsible to act as a subject matter expert (SME) for university relations best practices, strategies, processes, quality benchmarks, and standards for recruiting. Provide insights, recommendations, and strategic direction to our University Relations director on the campus environment, digital innovations, and best practices across UR to ensure best in class talent results and increase our attractiveness to the next generation of leaders. Establishes a network of internal stakeholders to create and grow relationships with various associations and schools to grow company presence at these institutions and organizations Skills...