Business Operations Project Manager We are looking for a Business Operations Project Manager to join the team in a highly collaborative, ever-changing startup environment.Our startup is a spin out of a successful life science commercial and strategy advisory firm that collaborates with companies' management teams and identifies solutions to successfully navigate the commercialization spectrum...

Responsible for development and implementation of strategic publication plan for assigned product Supervise execution of the publication plan to produce abstracts, posters, oral presentations, manuscripts and slide decks Plan, develop, and implement educational plan, and other scientific programs (including symposium) that communicate important information to the medical community. Manage and...

Looking for an experienced ServiceNow developer who know the Governance, Risk, and Compliance (GRC), SecOps and Vulnerability Management modules. The primary responsibilities will be the delivery of key security and privacy related functions related to performing Privacy Impact Assessments (PIA), vendor security assessments and security policy exception management. The IT Security and...

Specific Responsibilities and Skills: The Business Continuity Consultant reports to the Director, IT within the IT Program Management Office (PMO) group based in Foster City, California. This person is responsible for implementation of the Business continuity strategic and operational roadmaps, contributing to the annual Business Continuity Program goals and objectives required to achieve...

Responsibilities (include but are not limited to): • Support preparation and maintenance of Risk Management plans • Contributes to development and execution of Risk Evaluation and Mitigation Strategy (REMS), including the associated Elements to Assure Safe Use (ETASU), as applicable • Participates in cross-functional teams (e.g., Working Groups, Committees, etc.), involving interactions...

In partnership with CPMs, provides guidance and daily oversight for the successful management of all aspects of international clinical trials within designated program budgets and timelines. Coaches members of a work team and ensures adherence to established guidelines. Provide input to program budget and timelines to ensure successful management of all aspects of international clinical...

Supports the medical affairs area head with the following tasks: • drive the development and execution of the cross-functional product and disease strategy • Provide operational oversight on evidence generation activities under the medical affairs function in close collaboration with cross functional team • Provide strategic input and excellence in execution on launch plans for the disease area...

Technical Writer Quality Record Management - AGILE System   Demonstrates strong knowledge of current Good Manufacturing Practice (FDA, EU and ICH) requirements and Quality Systems, with the ability to assess compliance risks. Can work under tight deadlines while delivering a high-quality output. Demonstrates analytical problem-solving skills. Demonstrates ability to explain complex...

The SR Specialist/Lead, Materials Management will report to the Senior Manager of Materials Planning. In this role you will assist in product receiving and shipping at the 3PL warehouse within Oracle ERP system, and ensuring inventory accuracy and timely supply of materials to manufacturing production facilities. Managing and executing project to increase capabilities and functionality within the...

Study Manager The Study Manager will lead the planning and manage the implementation of late phase clinical research studies, including creating and managing study timelines, budgets and study management plans in a fully outsourced model. This role provides oversight of Clinical Research Organizations (CROs) and other vendors and may author, review and approve various study related documents...

Intelligent Automation Delivery Manager 1) Continue the build of the IA Center of Excellence (IA COE) Governance Refine Governance process and manage the end-to-end governance, from Demand intake through delivery and ongoing benefits measurement Define and build the ongoing templates to be used to manage governance processes 2) Manage the IA COE operations Oversee the completion of the "Cost...

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: ...

Pharmica seeks a PV Strategic Partner Manager to support the Pharmacovigilance department at our client site in the Basking Ridge, NJ. This is a 6-month contract position requiring 40 hour/week of on-site presence. Job Duties Manage Strategic Partnerships and contracts including vendor outsourcing agreements, partner contracts PV Agreements (PVAs) [Safety Data Exchange Agreements (SDEAs)]. ...

Clinical Supply Planning and Logistics Mgr Duties: Develops and updates Study Supply Plans in close communication with CSO project Managers. Responsible for the Clinical Label Development process which includes creation of master label text, translations, and label proofs. Manages CMO documentation reviews (i.e, packaging Batch Record) review and approval process with Quality Assurance and...

Pharmica seeks a Medical Writer with experience supporting Oncology programs to support the Regulatory Operations department at our client site in the Basking Ridge, NJ. This is a 12-month, 40 hour/week, contract position with the possibility of working remotely. Manage/Assist documents through the review process (coordinating document review meetings, collate and reconcile comments from...

Job Responsibilities: -Works on problems of moderately complex scope where analysis of situation or data requires evaluation of identifiable factors. -Responsible for planning and implementing activities related to the material purchase, material control, inventory control, and shipping/receiving and stores functions. -Frequently interacts with functional peer group managers. Interactions...

The Senior Manager, 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 Senior Manager will drive the scope of work, oversee CROs and will proactively manage patient safety and data integrity to ensure inspection readiness and compliance. The Senior Manager,...

Assists the development and implementations of robust global sourcing strategies for marketing and sales goods and services that link to core business deliverables while leveraging knowledge of the marketplace and supplier community. Takes a holistic view of spend and identifies category level demand management, leverage, and LCC opportunities. Contributes to defining and modifying the...

Position Summary · The successful candidate will be results-oriented with concerns for quality and collaboration. They will show initiative and want to continue to develop and acquire new expertise · Responsibilities of this position will include collaborating with company affiliates and alliance partners on an effective and efficient process for the global distribution and tracking of...

Drug Development Project Manager This is a Senior level Program Management (PM) role. The Program Manager will partner with the Program Team Leader to co-lead one or more Program Teams in the planning and execution of program development goals. This position will play a critical role in facilitating and managing cross-functional program teams from IND submission through Phase 2/3 clinical...

Pharmica is looking to hire a Government Affairs Project Manager! Job Responsibilities Political and Grassroots Management POA booth and development of materials Managing vendors Maintaining records for company spend and coordinating with contacts in Finance, Legal, and GA Managing outreach and on boarding of new members Pull through of GOTV (Get out the Vote) activities in coordination...

The Leader of Early Assets Development Market Research role is a leadership position designed to support the customer insights and strategy needs of the Global Marketing team’s development of pipeline assets.This position is responsible for the primary market research and competitive intelligence for assets in early development phases prior to launch of the brands.The Market Research Leader is...

The Director of Nephrology Market Researchrole is a leadership position designed to support the customer & market information/insights needs of the Global and US Nephrology Business Unit and Brand Teams.The position is responsible for leading the market research, competitive intelligence, and select business analytics and reports into the Senior Director of Commercial Strategy & Insights.The MR...

Medical Writer II The Quality department resides organizationally within Regulatory Documentation and Submissions (RDS) and provides various services including, but not limited to: quality reviews (data/content verification and consistency, style application, editing), audit readiness support, process improvement support, and compliance monitoring to support a wide variety of regulatory...

The Systems and Process (S&P) team is a dedicated, centralized group that provides strategic consultation, technical consultation, and internal customer service for the Development Operations team. The team promotes excellence in standards, processes, analytics, and business intelligence for the benefit of the company and patients everywhere. This position will serve as a Business Process...

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,...

Principal Responsibilities Drive project management processes (including scope, schedule, risk, issue, resource and budget management) Develop and maintain integrated project plan, status reports, risk and issue log, and other project related artifacts Facilitate the definition of the project scope, milestones, tasks, deliverables and resource requirements Continually identify, prioritize...

Job Responsibilities Collaborate with internal business partners (Marketing, Finance, Quality) to develop and manage a product manufacturing and distribution plan that provides continuous supply to customers. Review/analyze external reporting and maintenance of records, charts and tables for monthly reporting. Prepare release documentation in conjunction with Quality Management and entering...

Regulatory Finance Project Coordinator   Budget Activities: Internally tracks variances from budget Refines budget models Liaises with GRA contract responsible parties to ensure accurate cost codes and invoice receipt Compiles presentations on variances to GRA leadership Seeks process improvements by working with Finance and Outsourcing Helps to manage inputs from global affiliates...

Overview: The Executive Talent Acquisition Coordinator is a vital and integral role supporting the Talent Acquisition function. The ETAC contributes to the overall success of the team and candidate experience by providing a high level of customer service, administrative support, and project coordination throughout the recruitment process. This position will require you to develop an understand...

IT Project Manager Duties: Develop and manage detailed project plans inclusive of key milestones, critical path tasks, deliverables, and resource allocation Continually identify, prioritize, and mitigate risks of the program based on a balanced approach of best practice for Identity Access Management (IAM) solutioning, criticality of the requirements, and the impact to the key outcomes ...

Support the Associate Director, Integration & Innovation to implement a roadmap for emerging digital technology (e.g. artificial intelligence, electronic health record, etc.) to drive client into next generation technology. Facilitate in the development of a strategic roadmap for enhanced data mapping from source to reporting in both data visualization platforms and in delivery to the Quantitat...

Essential Duties and Job Functions: • Work collaboratively with global and regional regulatory product leads in supporting global clinical and nonclinical regulatory strategy development, planning, and implementation for multiple complex programs across the Gilead liver franchise • Provide regulatory guidance and critically review documents to ensure alignment of rest of world submissions and...

Responsible for managing service delivery of core commercial applications; Veeva CRM, Veeva Align, Salesforce Service Cloud, Veeva PromoMats and other applications supporting these core applications. He/She will manage a team and work closely with IT Business Partners, Commercial Operations and IT development teams to ensure service delivery for projects, enhancements and production support....

Duties: - Receive and process requests within the company eDMS for controlled document creation, changes, or withdrawal (Document Control, Change Requests). - Maintain tracking and processing of controlled documents relating to company Periodic Review process. - Maintain the system for records and retention using a standard categorization system in accordance with internal and regulatory...

Experience Partner with the business to understand SharePoint sites and what needs to be migrated Work with business to move custom sites to out-of-the-box sites in SharePoint. Develop solutions to satisfy requirements and articulate to the business Lead junior SharePoint Migration consultants on what to do pre-migration and review sites post migration Develop SharePoint sites as needed ...

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...

Pharmica is hiring a Regulatory Project Coordinator in the Princeton, NJ area! This individual should have 1-3 years experience in the field. Drive Global Regulatory Affairs (GRA) projects, initiatives and innovation activities Actively engage and collaborate with the Innovation/initiative leads and other GRA leaders to achieve the goals set out in the innovation agenda Coordinate cross...

We are looking for a Regulatory Project Manager to drive global Regulatory Affairs projects, initiatives and KPI generation. Actively engage and collaborate with the Innovation Lead and other GRA leaders to achieve the goals set out in the innovation agenda Lead and coordinate cross-organizational innovation initiatives and ensure that team members are aware of and meet all expected...

Senior CMC Product Manager Pharmica is seeking a Sr. CMC Product Manager to help drive the overall success of development & commercial programs within Manufacturing & Technical Operations at our client site in South San Francisco. Responsibilities · Work collaboratively with the Technical Leads and CMC Sub-teams to plan, track and report the diverse activities managed by Manufacturing &...

Project Manager is responsible for developing and managing a newly proposed clinical trial Patient Portal Project inclusive of cost, time and scope. Key activities will include developing and maintaining project plan, communication plan, issues/risks log along with allocating tasks, setting milestones, and collaborations with multi-stakeholders and vendor. Responsibilities: Using project...

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,...