Solution Architect – Regulatory

The Regulatory team is looking for a highly skilled Solution Architect, able to deal with the multicultural team. We are looking for an outgoing and open minded individual with high communication and presentation skills.

The Position

The Regulatory Information Management (RIM) Solution Architect is responsible for the architecture of our RIM systems including Global Product Registration System (GPRS), Product Information Dissemination (PID), Q&A, XEVMPD, Protocol Reporting System (PRS) and RADAR, as well as a key contributor to develop these systems to a state where they fulfill the current business needs and are well prepared to meet future demands. 

The main responsibilities are:

• Working in a multinational team of employees
• Oversee the technical solutions
• Document the as-is architecture
• Develop the future-state architecture
• Develop a roadmap for the systems
• Support the ongoing projects and design solutions on the existing platform
• Providing guidance in area of expertise to Project Managers and Technical Leads

TheImmunology, Tissue Growth and Repair Diagnostic Discovery Department is seekinga motivated, interactive and flexible Senior Research Associate to perform researchrelated to biomarker discovery and analysis in infectious diseases. 

Theposition will report to a Scientist lead for the Department's new program inInfectious Disease and Host-Pathogen responses. The successful candidate willimplement a variety of in vitro and in vivo molecular, proteomic and cellulartechniques to elucidate disease pathways and identify relevant biomarkers, andwill be expected to make intellectual as well as technical contributions to theteam. Responsibilities: Perform wet lab experiments, generate and analyze dataand communicate findings and interpretations relevant to the Department'smission to identify predictive and prognostic biomarkers for therapeuticResearch and Development programs. Specific responsibilities will include:performing exploratory disease-oriented research utilizing samples & datafrom human infectious disease cohorts, processing and analyzing clinical trialsamples, data analysis and presentation, and contributing to experimentaldesign/planning.

In the position of Senior Regulatory Product Manager in Technical Regulatory Affairs, you will be accountable for the preparation of regulatory submissions and strategies supporting the product’s lifecycle and business needs.  This role within Pharma Technical Regulatory is focused on the development of strategies supporting biologic marketed products.  The successful candidate must have demonstrated leadership capabilities, a proven ability to work cross-functionally, and recognized strengths in collaboration, teamwork and communication.  He/She will be tasked to navigate and lead the preparation of complex global regulatory strategies with support from global team members representing both technical regulatory and various cross-functional representatives. The successful candidate must have an ability to develop and drive innovative solutions to complex regulatory strategies while maintaining compliance with regulations.  With a focus on biologics marketed products, he/she will also be required to provide regulatory support for relevant quality systems such as change control, discrepancy management, and inspection management.  Additionally, he/she will support departmental business processes to document and improve best practices and work efficiencies.

He/she will be responsible for leading a team that delivers timely compilation and of all necessary documentation for regulatory submissions to support technical content of regulatory submissions. He/she will ensure quality; content and format of regulatory submissions comply with applicable regulations and guidelines governing the development, licensure and marketing of drugs and/or biologics.

Job Duties/Responsibilities:

• Perform microbiological, biochemical and analytical lot testing of raw materials, E. coli and mammalian cell banks, commercial and clinical fermentation, purification, and final product samples according to GMPs.
• Review data and assess against established acceptance criteria. 
• Evaluate data to identify trends and/or establish limits. 
• Identify gaps in and potential improvements to systems and procedures. 
• Perform equipment qualification and or maintenance. 
• Prepare and maintain standards, controls, stocks, and cultures per established procedures. 
• Assure and apply GMP throughout all operations. 
• Coordinate with customers to support multi-site operational activities. 
• Present analytical procedures and results during internal and external audits and regulatory inspections.
• Participate in and/or lead projects and process improvements. 
• Perform other duties as requested by managers to support Quality activities. 
• Works to meet schedules, timelines and deadlines. 
• Meets scheduled performance of 95% on time.

Technical Duties/Responsibilities

• Write technical protocols and reports under limited supervision. 
• Identify and propose resolutions for study or project deviations. 
• Provide input to and participate in assay transfer and assay validation.
• Perform technical review of data derived from complex tests. 
• With limited supervision, design and execute quality investigations and CAPA (corrective actions preventive actions) initiatives as needed. 
• Identify, troubleshoot, and propose resolution to technical problems. 
• Identify and propose resolution for discrepancies. 

Senior Project Manager – IT

The Senior IT Project Management position will be responsible for leading the delivery of technology projects in support of US Commercial Operations. The Senior IT Project Manager is accountable for the successful delivery of technical solutions through effective planning and execution throughout all phases of our project management methodology. The Senior IT Project Manager will be responsible for managing assigned resources, effectively tracking budgets and financial forecasts, creating and tracking detailed project plans, effectively leading and facilitating project meetings as well as proactively controlling project scope, risks and issues. This position is expected to provide timely status reports to all stakeholders and escalate issues to the appropriate management level. The Senior IT Project Manager will be accountable for all projects in the Commercial Compliance Solutions portfolio, either through direct management of projects or by sourcing and overseeing contract Project Managers. 

Duties:

* Define, plan, and direct the execution of a broad range of technical projects, while balancing the competing demands of scope, time, cost, quality, resources, and risk

* Identify, acquire, and lead multifunctional project teams

* Manage a portfolio of projects, in addition to individual projects assigned to the position

* Ensure project objectives/requirements are clear and agreed to by all stakeholders

* Manage relationships with various technology and business communities to achieve 

project objectives

* Facilitate project management activities across the entire project management methodology

* Establishes and maintains effective communication for assigned projects and with dependent projects

* Ensure successful and timely completion of deliverables

* Track progress against baseline schedule

* Plan, baseline and control costs to ensure projects are completed within approved budget

* Identify and apply systematic quality activities to ensure that projects employ all 

processes needed to meet Computer System Validation directives

* Suggest improvements where necessary / appropriate to improve operational efficiencies

* Conduct risk management planning, identification, analysis and monitoring on projects

* Formulate risk mitigation strategies and recommend solutions

* Manage the processes required to ensure timely and appropriate generation, collection, distribution, storage, retrieval, and ultimate disposition of project information and documentation necessary for successful communications across all stakeholders and any required updates to living system documents for validated systems

* Other duties as assigned

Position Summary:

Provide Project and Program Management for IT business solutions that have significant impact to the enterprise in North America ERP Demand to Supply, Manage Finance, and Order to Cash solutions.

The position will work closely with the North American ERP organization to plan, manage and deliver process and system initiatives. As a senior project manager this individual will lead the deployment of SAP systems and processes across Pharma in the North American region. Responsibilities include future SAP site implementations, enhancements, functional transformation projects and infrastructure related projects.

This position provides expertise needed to effectively implement projects and continuously improve processes. This individual will also partner with business project managers while working with the Pharma IT organization to drive requirements and successfully complete projects.

The purpose of the department is to a) provide IT services for the NA regional ERP solutions, b) deliver enhancements and projects for the regional ERP solutions, c) ensure the services are delivered to established customer SLAs, and d) provide a local/regional presence for the ERP IT group.

2-3 most important contributions of this department

Understand the local and regional business needs for the ERP solutions. 
Deliver operational services for the regional and local Demand to Supply, Manage Finance, and Order to Cash solutions.
Deliver enhancements and projects for the Regional Demand to Supply, Manage Finance, and Order to Cash solutions.

Main customers are the regional/local Finance group, regional/local Tech Ops group,  Local Order to Cash group.

Main PI collaborations are with ERP Architecture, global ERP Solution Owners, Business Project managers, IT Application Technical Leads,  AE&O.

Major Responsibilities:

• Developing work plans, managing deadlines and coordination of project team and sub-team activities
• Estimating project skill requirements, and then working with resource deployment managers to identify appropriate resources and manage their integration into the team
• Defining and agreeing on deliverables , risk management and milestones
• Setting and controlling scope
• Communicating status and vision to client management and stakeholders
• Create a collaborative environment which promotes communication across the organization, at all levels: including but not limited to the Steering Committee, Enterprise Architecture, Departmental Managers and Information Technology.
• Provides overall team management, including regular evaluations
• Prepares and delivers executive presentations and facilitates workshops/meetings.
• Ensures procurement and sourcing procedures are followed.
• Provides Functional Manager with feedback on team member performance.

The successful candidate will be a key member of the Cross-Portfolio Analysis & Communications (CPAC) team within PPP/Pharma Portfolio Management. The CPAC team provides management with late stage and cross-portfolio information that enables a shared understanding of the portfolio, and robust analytics that offer unique insights on Roche’s direction, strategic alternatives, and ultimately contribute to effective corporate decision-making.

Responsibilities:

• Representative responsibilities associated with the role are detailed below:
• Develop analytics around portfolio spend, future portfolio projections and “what if” scenarios
• Assess Roche’s performance versus competitors across various R&D-related metrics
• Provide guidance to, and participate in, cross-functional initiatives on R&D productivity, cost and valuation metrics, and long-range planning
• Participate in preparation of quarterly reports for senior management on progress of portfolio and implications

Job Skills and Expectations

• A strong understanding of pharmaceutical/biotech industry, drug development trends, and business strategy
• Financial acumen and understanding of commercial and development forecasting methodologies
• The ability to analyze and draw conclusions out of large, complex data sets and articulate the key findings to management and functional leaders
• Strong oral and written communication skills
• Innovative mindset and comfort with ambiguity
• The ability to build cross-functional partnerships and engage in (and at time lead) cross-functional initiatives
• A desire to make a difference and commitment and drive to see things through

The Manager / Senior Manager will support the late stage PPP team as itdelivers on a range of projects in support the late stage oncology portfolio.  Key activities forwhich PPP is responsible include:

• Portfolio Management and Reporting
• LifeCycle Team, Planning, Governance and Decision Support
• Strategic Projects at the TA Level and Cross-Portfolio
• Governance / Support for Late Stage Portfolio Committee

The role requires ability to providestrategic, analytical and systems support to late stage teams, TA heads, andother stakeholders in the Roche organization.

Responsibilities

Representative responsibilities associatedwith the role are detailed below:

• Portfolio Management and Reporting
• Participate on multiple lifecycle teams and ensure that portfolio reflects ongoing investments in programs
• Prepare quarterly reports on progress of portfolio and implications (incl. strategic context) for senior managers
• LifeCycle Team, Planning, Governance and Decision Support
• Consult with lifecycle teams to provide decision analysis and other analytic and strategic support
• Support development of business cases for all investments/changes, including valuations
• Facilitate annual prioritization, goal setting, lifecycle planning and business planning processes
• Advise teams on internal governance processes associated with changes/new investments
• Strategic Projects at the TA Level and Cross-Portfolio
• Support development of molecule, pathway and disease area strategies
• Frame portfolio issues and conduct gap analyses to enable management to make informed and timely decisions, including corporate goal setting and portfolio optimization
• Facilitate TA level opportunity prioritization and strategic context
• Support partnering opportunities at the TA level
• Governance / Support for Late Stage Portfolio Committee
• Work with development teams to ensure that decisions go through appropriate governance
• Advise teams and stakeholders to ensure decisions are aligned with portfolio priorities

Job Skills and Expectations

We are recruiting for the position of Service Provider Strategy Lead to join our international Product Development Quality Assurance (PDQA) team.

Reporting to the Team Lead for Service Provider QA Strategy the ideal candidate will be responsible for the design and implementation of the Service Provider risk management and audit strategy across the GLP, GCP, GPVP areas. The role works in partnership with Procurement/Outsourcing Functions and the PDQA GLP, GCP, PV Strategy Leads to ensure that Risk Assessments are maintained across the inventory of Service Providers engaged globally (gRED, pRED, PD, GPS/gMED) and at Affiliate Level. 

This role monitors activities outsourced to Service Providers through periodic risk assessment, risk-based routine audits and provides ongoing support to mitigating actions. It also provides actionable data to Senior Procurement/Outsourcing functional management based on analysis of data (audit/inspection/risk) and identification of trends.

The ability to influence business partners in the area of service provider risk and quality management is essential to proactively identify and address issues with the skill to ensure that service provider quality issues are addressed in a timely manner and that the relevant management functions in the organizations are kept informed.
Key responsibilities and tasks:

• Design and implement the PDQA Service Provider risk-based strategy for risk management and audit activities
• Define/maintain the “audit/risk universe” of Service Providers based on input from Procurement/Outsourcing functions and PDQA GxP Strategy Leads
• Partner closely with the GxP Strategy Leads, Procurement/Outsourcing Functions to ensure that risk assessments are maintained for Service Providers to determine which audits will be conducted and where risk mitigation activities should occur. 
• Develop and implement a GxP risk based strategy to deliver an audit program and quality oversight model for service providers within service category areas. 
• Assess specific risk areas on an on-going basis, communicate to PDQA senior leadership and propose modifications to PDQA strategy where necessary 
• Develop and maintain risk assessment tools 
• Assess data/metrics from audits, inspections and risk management activities for compliance trends and risks 
• Develop communication tools (reports/dashboards) for audit and inspection metrics and trends
• Escalate significant compliance issues to PDQA Management
• Represent QA on Service Provider sourcing initiatives and Strategic Alliance or Category governance teams, participating in Service Provider due diligence visits where appropriate.
• Support regulatory authority GCP inspections at service providers.
• May lead or participate in GCP audits at service providers
• Provide leadership and direction to PDQ/PDQA and our customers/stakeholders on GxP related activities/issues related to Service Providers  
• Establish strong partnership/relationship with key stakeholders in Procurement and Outsourcing functions
• Review and provide feedback on service category area risk mitigation plans/CAPAs
• Provide quality leadership on complex issues (i.e., CHD) to Procurement/Outsourcing functions and PDQA staff
• Represent QA on Service Provider Strategic Alliance or Category Governance teams.
• Contribute to the development and execution of PDQA goals and initiatives
• Participate in or lead departmental or cross-functional compliance projects and initiatives as assigned
• Assists and/or contributes to the development and/or revision of PDQA SOPs, guidelines and tools
• Maintains knowledge of GLP, GCP, PV regulations and internal policies and SOPs  
• Maintains highest level of awareness and expertise in international GxP/PV regulatory requirements, guidelines, and policies, and applicable Roche/Service provider SOPs and project-specific procedures. 

The Senior Finance Business Partner will support senior leaders in Technical Regulatory and Quality and Compliance (RQC).  Quality & Compliance, the broadest Functional Unit of the PT network, spans the Biologics, Small Molecule and Contract Manufacturing Operating Units.  As a business partner, you will contribute a business perspective as a member of the leadership teams and drive the planning, reporting and ad hoc financial analyses to support each of these leaders and their teams.  This position is focused on global controlling but has significant local controlling responsibilities, too.  The successful candidate will be seen by his/her business partners as a thought leader in financial issues and a “go to” person for financial / business advice. 

This position, based in South San Francisco, will report to the Head of Finance, Quality & Compliance and Technical Regulatory, located in Basel, Switzerland.

MAJOR RESPONSIBLITIES 
• As a contributing member of numerous leadership teams, provide business partner support to South San Francisco based Technical Regulatory and Quality & Compliance leaders and their respective global leadership teams. 
• Partner with RQC leadership to understand and seek new business drivers and key operational issues; actively identify tactical and strategic opportunities; contribute to the development of appropriate financial and performance metrics; recommend decision frameworks and present to senior management.
• Lead RQC global functions’ planning and forecasting exercises.
• Provide accurate and timely monthly management reporting.
• Provide decision-support analysis to management on projects and initiatives.  Leverage technical financial knowledge and available data to ensure analyses are well founded and thorough.
• Develop logic, models and presentation material for demonstrating/communicating value proposition for services provided by Regulatory, Quality & Compliance evaluating business need and significant changes within PT and Roche.
• Work closely with Accounting and Global FMT resources to ensure that RQC global functions’ financial and accounting data are accurate and aligned with principles governing technical operations including GAAP and IFRS (FGAR).
• Work with Capital Planning to ensure RQC needs are communicated and included in the Capital budget, forecast and business plan exercises.

Sr. Finance Manager – Pharma Finance Development (PFD), South San Francisco

Description:

The Pharma Finance Development group has ~ 45 people in multiple locations around the globe.  It is a cross-functional, cross-cultural group that supports the Roche Product Development organization.  This role is based in South San Francisco and reports directly to the Director of SSF Pharma Finance Development. 

The Senior Finance Manager is responsible for providing financial management and decision support to the Product Development organization. 

Major Responsibilities:
•   Provide local financial controlling support to several functions within Product Development (Biometrics, Portfolio Management, Global Medical Affairs, Quality)
•   Provide global controlling support in collaboration with global functional controller for Biometrics
•   Act as internal consultant by providing financial consultation and guidance to business partners as needed;  support business in understanding state of finances and actions required to achieve business objectives
•   Provide support for all budgets & forecasts for respective local and global functions supported throughout the year
•   Prepare and present monthly financial results to functional leadership
•   Participate and drive key strategic projects for PFD in support of Product Development
      o Provide strategic financial analytical support that both measures and drives efficiencies within the Development organization and improves decision making
      o Present analysis to PFDLT and the PDLT sub-functions
•   Collaborate with Global Controllers, Life Cycle Controllers and Global Development Heads on cross-functional projects and to ensure Product Developments meets its business objectives

Senior Finance Manager - Commercial Finance

The Senior Finance Manager is responsible for providing financial management and value-based business decision support to the Nutropin and Pulmozyme Franchises within the Genentech Commercial organization. This position reports to the Director, IMPACT Decision Support within Commercial Finance, and could be a Finance Manager depending on the candidate’s background and experience.

 

RESPONSIBILITIES

• Act as a business partner who adds value by understanding the needs of the business and proactively identifying opportunities that drive financial results
• Act as an internal consultant by providing financial consultation and guidance to business partners as needed; support business in understanding state of finances and tactical/corrective actions required to achieve objectives
• Partner with brand teams on business development opportunities to provide financial/value perspective.  Build Xcel-based financial models to influence and drive negotiations and deal participation
• Conduct forecasting and analysis of marketing and sales expenses in support of business planning deliverables (10-year Business Plan, 3-year Brand Plan, 1-year Tactical Plan/Budget, quarterly corporate forecast submissions)
• Conduct month-end close for brands – review posting of appropriate journal entries by Finance Analysts and provide explanations on variance/performance drivers to Nutropin and Pulmozyme Brand Teams
• Monitor compliance with financial policies and recommend/take actions as needed
• Prepare and present financial reports requiring translation of complex quantitative data to multiple levels of business partners
• Conduct financial data mining and value-based business analysis to provide insights and guidance in support of business decisions and objectives
• Build and maintain effective partnerships with Product Managers, Marketing Directors, Franchise VPs as appropriate, and others within Commercial Finance
• Support strategic projects for IMPACT and Commercial Finance as needed to inform business decisions
• Mentor and develop Financial Analysts (indirect report)
• Participate in process improvement initiatives within Commercial Finance

• Demonstrates theoretical/financial and cross-functional understanding in financial problem solving; works effectively on issues where analysis of situations or data requires in-depth evaluations of variable factors with intra-Commercial impact; demonstrates judgment in selecting methods and techniques to solve routine financial and tactical problems of moderate scope and complexity; contributes sound ideas in developing recommendations for more complex problems; anticipates problems and offers solutions
• Solid experience and facility with distilling business development and M&A situations into key drivers that can be modeled in Xcel
• Interacts and collaborates effectively within workgroup and area of expertise; participates effectively on cross-functional teams; offers views and actively solicits ideas from others in seeking sound business solutions; encourages others in fostering effective teamwork; demonstrates very strong customer service orientation
• Gets point across clearly, with straightforward language, both verbally and in writing; considers the needs and interests of others and incorporates information relevant to them in communications; readily grasps the main points in communications from others
• Plans, prioritizes and reports status on tasks; operates independently with limited supervision, holding self accountable to fulfill assigned tasks and achieve results within timelines; establishes own work priorities and timelines within scope of authority; responds to requests with appropriate urgency and an organized approach; may provide guidance and coordinate work activities of others
• Monitors process effectiveness and efficiency against goals and objectives, taking corrective action as necessary; identifies, implements, and supports complex process improvements
• Understands strategic priorities developed by upper management; recognizes relationship between workplace results and what caused them; able to shift between tactical and strategic perspectives based on audience and project needs

Responsible for the administration and operation of the site’s programmable logic controllers (PLC) and provides instrumentation and control engineering expertise to the Engineering Group. Focus on providing operational support for existing facilities with respect to the instrumentation and control systems for process, utility and building systems. Provides operational support and interfaces with the Siemens Building Management and Emerson Delta V systems as needed. 

Job Responsibilities

Essential
Serve as the site subject matter expert for the various PLC systems
Act as the PLC system super user and ensure system equipment and software are maintained in an operational state
Train personnel to interface with PLC systems on equipment and add or delete users based on training status.
Generate alarm reports, identify trends and review data with Quality.
Perform instrumentation and control engineering design services for existing facility projects, including upgrades and capacity expansions, equipment upgrading and replacement.
Review and approve design drawings, and Process & Instrumentation Diagrams which include all line sizing, instrumentation and control philosophies,
Review design specification testing and perform field inspection services.
Interact with vendors.
Review and approve vendor information packages, including drawings and specifications as directed to ensure validation and control system requirements are met.
Play a lead role in the start-up and troubleshooting of process equipment and critical process utility systems.
Generate controlled documents to support the start-up, operation, validation and maintenance of equipment and systems located in existing facilities. Examples include functional specifications and detail design specification.
Provide input into the validation of process equipment and associated utilities.
All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area.  Fosters a positive safety culture in which no one gets hurt.

Supplementary Responsibilities
Support work of the Engineering Group, which includes research/evaluate instrumentation and control components, review/modify control system concept/logic as a result of troubleshooting.

The Senior Corporate or Corporate Counsel will work as part of the Healthcare Law Group within Genentech's Legal department. 

The position will initially focus on counseling Genentech’s commercial sales and marketing clients, with opportunities to advise medical affairs and development across the lifecycle of products. The position may require counseling medical affairs and development teams with human medicines and companion diagnostics in all phases of development.  

 JOB/POSITION SCOPE:  

•  Manage outside counsel on complex or more advanced matters or projects 
•   Responsible for one or more key client relationships typically at Director level or   higher 
•  May be single point of contact or represent practice group or functional area on significant projects or committees 
• Provide advice, education, training and legal direction on FDA labeling and promotional matters, healthcare fraud and abuse laws, product liability, antitrust, privacy and other laws impacting the commercialization of biotech products;
•  Assist in structuring tactics and related contracts in compliance with applicable law;   
•  Serve as lead legal counsel for global development programs and medical affairs initiatives
• Negotiate agreements with cooperative groups, government entities, study sites, and other parties involved in global studies; and
• Draft and interpret  company policies, and educating clients and colleagues about enforcement trends and discrete legal issues.   
• Act as a subject matter expert on all matters relating to healthcare law and related business operations 
•  Act as a standing or ad hoc member of business or leadership teams and provides legal counsel and expertise into business decisions 
•  Develop an in-depth understanding of assigned departments and functions in terms of their, organizational structure, processes, business goals, strategies and challenges, etc. 
•  Provide  legal advice in matters relating to healthcare law, including healthcare fraud and abuse, FDA regulations on clinical trial conduct, labeling, advertising and pharmacovigilance, product liability, pricing and reimbursement, antitrust, privacy, and other matters relevant to the development, manufacture and commercialization of products 
• Provide  input and legal advice on business strategy, tactical plan development and implementation, and other business issues; including legal assessments, solutions-oriented risk mitigation strategies, messaging, and interactions with healthcare professionals, patients and other external parties 
•  Participate  in, lead  and/or present  to various Company committees or other advisory, project or work teams and provides healthcare and business law expertise and guidance 
•  Review  business materials (clinical trials, brand plans, promotions, medical plans, publications, training documents, etc.) requiring legal input and advises internal clients, partners and stakeholders on compliant strategies, plans and tactics 
•  Provide  transactional support to assigned internal clients. May include drafting, negotiating, and/or reviewing contracts, creating, updating and training on contract templates, negotiating language, developing associated legal/contractual documentation and/or policies & procedures, and counseling on contract disputes   
•  Interact and communicate with Roche affiliates and global partners, as appropriate, to apprise them of relevant Company policies, procedures, practices, important business issues, etc. and share best practices or coordinate legal support 

 PEOPLE MANAGEMENT: 

• May manage administrative personnel 
• Where applicable, lead recruitment, hiring and on-boarding for direct report positions 
• Accountable for direct reports' work to ensure on-time, on-target and within-budget results 
• Ensure direct report(s) are appropriately trained, developed and coached 
• Responsible for performance management of direct report(s)

DEVELOP & MAINTAIN  KNOWLEDGE 

• Stay abreast of evolving healthcare and related legislation and regulations and the enforcement landscape. Advises the Company and colleagues of potential implications to current or future strategies and operations and assures ongoing compliance 
• Develop and implements training to educate internal clients, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal c...

Summary of Position:

The Compliance & Training associate reports directly to the Manager, Compliance & Training. This individual will work closely with the US Drug Safety staff to support all safety-related activities accountable to US Drug Safety.  In addition, interactions US Medical Affairs Compliance will also occur on an as-needed basis. 

Job Duties/Responsibilities:

• Training of vendors and other 3rd parties to drug safety reporting requirements
• Working with commercial organization to ensure monitoring of Genentech sponsored websites for adverse event reporting
• Oversight of US Drug Safety audit and inspection findings and CAPAs
• Oversight of US Drug Safety local procedures and controlled documents
• Management of US Pharmacovigilance & Safety Data Exchange agreements 
• Management of US Drug Safety global pharmacovigilance commitments
• Monitor IT issues
• Management of special projects
• Track US pharmacovigilance metrics
• Conduct vendor assessments for AE reporting compliance
• Interact, where applicable, with US Medical Affairs Compliance to address safety-related issues or concerns

The IT Business Systems Analyst position will be responsible for working closely with partners across lines of business and the IT group in order to understand strategic drivers and tactical needs to ensure that implementation teams can provide solutions that meet the business need with the necessary stability, usability, and scalability. The IT Business Systems Analyst will be supporting projects in the global Laboratory Information Management Solutions portfolio for manufacturing and clinical Quality Control laboratories.

Duties:

• Analyzes business scenarios and identifies opportunities for improvement through automation and/or business process change
• Provides analytical expertise in identifying, evaluating, designing and developing systems and procedures that are cost effective and meet user requirements.
• Develops user requirements, functional requirements and/or technical specifications, process flow diagrams; may configure some system settings and/or options.
• Provides consultation to users in the area of business systems and processes.
• Leads cross-functional analytical teams in the resolution of business or systems issues.
• Leads successful completion of major projects/programs across portfolios. 
• Champions accountability by example.
• Applies advanced technical principles, theories, and concepts related to requirements, data, usability and process analysis.

• Other duties as assigned:
• Conducting 1:1 or group interviews, facilitating workshops
• Facilitating and supporting GMP validation, system and user acceptance testing
• Participating in roadmap discussions and vendor assessments
• Overseeing and mentoring less senior resources on solution or project teams
• Overseeing consultant resources as applicable

All candidates are encouraged to apply, however a preferred candidate has been identified.

The ideal candidate must have demonstrated the ability to handle confidential, complex and sensitive information, and the ability to establish administrative processes and procedures to assist the group with projects and tasks.  Candidate will provide accurate and effective administrative support for Managers within the group and coordinate administrative duties with other Administrative Professionals to provide seamless support for the group.

*Manage multiple schedules with heavy calendaring of complete meetings.  Arrange, coordinate and support meetings, events and activities both on and off-site.

*Identify and anticipate needs of the group and plan work activities accordingly.  Look for areas of activity overlap with co-workers and leverage resources to maximize time, resources and dissemination of information.

*Generate, disseminate and maintain documents and information.  Develop, implement and evaluate department work processes and procedures.  Manage deadlines related to business planning as well as special projects.

*Collaborate with Admin team to support complex projects and deadlines.

*Understand and troubleshoot from a broader perspective and anticipate the impact of office admin problems and solutions on the other areas.

* Understanding and experience with approval processes for vendor contracts, ideally within GNE, is highly desirable. A large fraction of the workload for this position will be administering contracts for HEOR research partners.

General office responsibilities include but not limited to:

 *Schedule and coordinate staff onsite/offsite meetings, assist with special projects, schedule travel for staff, process payment and expense reports, plan, schedule and coordinate WebEx’s and teleconferences, maintain files, order department office supplies, order catering and other supplies for a variety of meetings and events, fully utilize MAC and software applications.  Exercise independent judgment and discretion of sensitive/confidential information.