Sr. Product Manager

 Senior Product Managers in Managed Care Marketing develop, implement and manage the managed care marketing strategy, plan and tactics. Managed Care Marketing directly supports Genentech’s business by ensuring managed care marketing strategies, plans and tactics enable business, financial and operational goals, targets and objectives to be met or exceeded across managed care segments within the U.S. Senior Product Managers act as a primary liaison to managed care account management and may also have matrix responsibilities to represent Managed Care Marketing for one or more products or franchises, as assigned.

•  Stays abreast of and continuously develops his/her knowledge regarding internal and external business developments and drivers. Includes in-depth knowledge of the current and evolving managed care landscape and its implications for Genentech -  formulary positioning, reimbursement, access and overall market share

• Responsible for educating internal partners and stakeholders regarding the managed care landscape in the U.S. and related territories and implications of such to current, medium- and longer-term managed care marketing strategies, plans and objectives

• Reviews and assesses cross-functional business strategies, plans and tactics; using to determine and recommend managed care marketing strategies, plans and activities that support optimal formulary  positioning, reimbursement, access and overall market share

• Contributes new creative, innovative opportunities; increasing adoption, pull-through and overall financial results

• Develops the Value-based Healthcare (VBH) strategy and tactics; including driving and shaping key customer partner initiatives in oncology

• Works closely with cross-functional teams to align therapeutic area and managed care marketing strategies, plans and tactics with pricing, reimbursement, contracting, distribution and other relevant business, financial and operational strategies, plans and objectives 

• Contributes expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year strategies and tactical plans

• Conducts field visits with key customers to review Genentech’s breadth of offerings

• Develops key VBH resources for MCCO (Managed Care & Customer Operations) field, collecting customer insights, creating tactics for case managers and training MCCO on resources

• Where applicable, supports product launches. May participate in the development and implementation of managed care marketing launch plans. Includes contributing managed care marketing expertise to other aspects of the overall launch plan and helping ensure launch plan excellence

• Works with cross-functional groups to ensure a seamless and well-integrated message and overall positioning across multiple marketing platforms, e.g., online, direct-to-patient, etc.

• Provides strategic consultation to brands and MCCO groups regarding key brand market events

• Creates appropriate marketing budgets by working with peers, manager and/or other internal partners

• Ensures appropriate and timely implementation of approved managed care marketing plans and tactics under his/her responsibility

• Continuously monitors and measures effectiveness and results from managed care marketing strategies, plans and objectives. Regularly reviews forecasting and other business analyses and uses to make appropriate further recommendations to increase market access, address currently unmet needs, and generally help to improve the overall market strength for Genentech in assigned managed care segments

• Directly manages the implementation of all assigned managed care marketing plans and tactics to ensure timely and quality execution that will meet or exceed assigned targets, goals and objectives

• Works with others to identify, recommend, create and help implement new account management tools/resources that will enable the field to represent Genentech in accordance with the defined strategy and position
  Complies with all laws, regulations and policies that govern the conduct of GNE activities
  

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The USMA Manager of Systems and Processes works closely with the business to define strategies for development, implementation and improvement of core business processes and workflows to support the business needs in alignment with local regulations and corporate policies. This includes defining current processes, establishing mechanisms to identify process gaps and develop solutions, establish quality control measures for processes and system data, and coordination of process and quality improvement projects. The Manager of Systems and Processes is responsible for analyzing, refining and developing processes through to implementation and beyond to support decision making by USMA management.

Job Duties/Responsibilities:

• Organize and facilitate teams to critically review current business processes for quality, simplification and effectiveness and to identify requirements requiring cooperation and support from cross-functional stakeholders/business partners, establishing links between business strategy and process improvement initiatives and use of systems.
• Develop procedural documents, working documents and clinical study manuals in compliance with regulatory requirements and global processes.
• Routinely prepares reports by collecting, analyzing and summarizing information to support portfolio planning and study management activities and decisions.
• Collaborates with local or global reporting teams to create USMA specific reports to ensure accurate data is reported to management and enable good business decisions to drive business success.
• Collaborates with USMA stakeholders and other business partners to ensure appropriate documentation and integration in to process maps.
• Regularly attend cross-functional staff meeting to present system and processes project and process improvement activity status.
• Represents USMA on global systems/processes initiatives contributing to maximize functionality and ensuring alignment.
• Serve as internal advisor to address systems/process related questions and gather information to distinguish requests from true business needs.
• Develops tools, templates and procedural documents to support the tactical application of business processes as required.
• Routinely solicits feedback from users on systems and process enhancements, training and other ways of driving more effective systems/processes integration.
• Provides input to training programs and team effort by accomplishing related results as needed.

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Sr. Planning Manager, Access Solutions  Responsibility & Accounting Quality and Compliance 

The candidate will need to live within the South San Francisco, California area. Relocation assistance will not be provided.

The Quality and Compliance Manager has an advanced knowledge base regarding Healthcare Compliance and Privacy, or Operational Quality. This position is responsible for leading and maintaining all aspects of quality and general compliance within the Access Solutions Organization, keeping abreast of all healthcare and compliance ethics, operational quality measures and the management of external business partners. Additional key responsibilities of this role are: compliance risk management, cross-functional and multilevel partnership, represents the Assess Solutions Organization on compliance related matters.

• Extensive knowledge of organizational leadership and quality models, theories, tools methodologies and processes.
• Deploy change agent strategies in support of organization-wide continuous improvement efforts. Develop teams and participate on them in various roles
• Develop and maintain organizational focus on the importance of quality and performance excellence. Create quality policies and procedures in support of the strategic plan, and integrate those policies and processes into the tactics developed to support the strategic plan.
• Demonstrate management abilities in human resources, financial, risk, and knowledge management applications. Use effective communication methods in various situations to support continuous improvement efforts. Select and use appropriate tools and methodologies to plan, implement, and evaluate projects. Develop, deploy, and evaluate quality plans that can be used throughout the organization. Evaluate and recommend appropriate quality models or systems to implement in various situations.
• Integrate quality and compliance risk/context and business knowledge to address complex problems; provide communications to business partners.  Keep current in the area of healthcare compliance and ethics. 
• Manage, identify and address quality and compliance issues.
• Provide verbal and written communication to internal and external partners regarding clear and concise quality and compliance guidance and context.
• Deliver well organized presentations to leadership the leadership/ senior leadership teams
• Manage outside consultants, vendors, etc., effectively for specific projects with moderate corporate impact within assigned budget guidelines
• Develop resolutions to complex compliance problems, impacted goals, and objectives of business partner groups.
• Act as the subject matter expert for quality/compliance issues/questions.  Represent Access on project teams, multi-disciplinary groups and peers for projects or contracts.
• Interact with business partners on quality and compliance matters of medium to high risks.
• Represent the company as a primary compliance contact on concerns related to Access Solutions.

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The Global Engineering team is responsible for making technology happen for Genentech and Roche global by transforming the “technology roadmaps” into live solutions. The Global Engineering team is present in 4 locations: Basel, Madrid, Shanghai and South San Francisco, covering all time zones with around 100 highly qualified engineers. The Senior Network Engineer, NALA Region position is located at the South San Francisco site. The main responsibilities of the position are:

• Design and develop technology solutions, including evaluation of promising technologies and development of evaluation criteria
• Work with vendors, architecture, operations and solution owners managing the Proof of Concept and testing scenarios
• Perform configuration, integration, functional specifications and development tasks for technology solution and services, including first implementation of the designed solutions
• Develop best practices for technology solution for reuse across the compute environment
• Ensure efforts and solutions align and adhere to the organization’s Technical Architecture Framework (TAF) policies, standards and direction as well as Solution Owner requirements
• Ensure proper training of support teams on the technology solution
• Stay abreast of operational difficulties and issues; work with support team staff to provide escalation support 
• Document and optimize technology solution environment as required
• Ensure Quality standards as per company specifications are followed
• Occasional travel and working outside standard office hours including weekends and holidays

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The senior DBA manager leads and manages a staff of Database Administrator (DBA) professionals for Genentech database environment that includes Oracle and SQL Server. The individual will work with other global IT team leaders to translate the organization's IT strategy into specific database roadmaps and deliverables, measures the effectiveness of the delivery model, and track progress against plan and operational Service Level Agreements (SLA). The individual will provide management and implementation of strategic initiatives for the enterprise databases services in the charge toward efficiency and optimization. In addition, the individual is responsible for developing processes and procedures for overall IT Operations, upgrading and maintaining IT processes,production controls, capacity planning, and system backups and recovery. 

Key Strategic Objectives

* Lead the organization through organizational change, technology transformation, and sustained growth while exhibiting excellent judgment on how to prioritize between operational excellence and financial prudence

* Drive successful creation of a strong team dynamic in a collaborated and risk-taking

culture. Translate the organization's strategy into tactical execution plans replete with key performance measures and monitor the results on regular basis

* Improve Genentech's return on invested capital by having a systematic capacity planning process to maximize the utilization of assets and increase the velocity of infrastructure investment in virtualization and cloud computing.

* Build and develop future leaders of the organizations while advancing Genentech's image as one of the best places to work in America.

Responsibilities:

• The right candidate for this position is well organized, and an exceptional communicator with his/her team, peers, executive management, and the company. 
• This person must be able to lead and manage change. The individual will live by metrics, staying ahead of the tactical while also deeply understanding the needs of various business teams to appropriately plan for growth and change.
• Demonstrated ability to lead and energize multidisciplinary teams with gifted communication and interpersonal skills. 
• Demonstrated analytical, problem-solving and conceptual skills. 
• Ability to analyze project needs and determine resources needed to meet objectives. 
• Demonstrated negotiation skills with vendors or management and ability to influence management regarding matters of significance to the organization. 
• The successful candidate must be able to establish credibility very quickly in organization with shifting priorities. 
• The individual must be a strong leader who can prioritize well, communicate clearly and compellingly and who understands how to drive a high level of focus and excellence with a strong, talented, opinionated team.
• The individual will have a technical aptitude particularly in the database domain and be credible as leader in a technical organization. 
• The individual will be able to articulate with full clarity the aspiration of his teams, and achieve results through influence and leadership rather than direct authority...

The general purpose of the Senior Manager, Commercial Training & Development role is to help structure and directly manage the development and implementation of appropriate and aligned learning & development in support of assigned functions across Commercial Operations. As such, the Senior Manager, Commercial Training & Development manages a team of assigned trainers, and/or instructional designers and other project-based or administrative staff, and does so to ensure the assigned team meets or exceeds their goals and objectives. 

The Senior Manager, Commercial Training & Development may be assigned core sales, product knowledge, marketing, or other core Commercial Operations functional skills development curricula in support of assigned Commercial Operations functions, or he/she may be alternatively assigned core aspects of a Commercial Operations-wide development segment such as cross-functional leadership or management development. Incumbents in the Manager/Senior Manager, Commercial Training & Development role, as all other employees, are fully accountable for compliance with all laws, regulations and policies that govern the conduct of Genentech activities. 

As a manager of others, the Senior Manager, Commercial Training & Development is not only accountable for his/her own compliance, but also for the compliance of all individuals in his/her team. As such, leads the way and leads by example by demonstrating full knowledge and commitment to all applicable policies. Monitors adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required. 

MAJOR RESPONSIBILITIES ¿

* Has a thorough understanding of the applications and benefits of Genentech's products.

* Determines the most effective approach to meet product learning needs of the business. Applies instructional design principles and adult learning principles to enhance content delivery. 

* Performs detailed needs assessments in coordination with Brand Sales and Clinical Trainers. 

* Translates business needs to training products and programs.

* Establishes goals and learning objectives to design appropriate and effective curriculum by leveraging adult learning principles.

* Researches the issues and leverages resources (internal and external) to support the learning objectives in designing and creating training programs and products

* Oversees the preparation of training products and programs such as classes, workshops, learning modules, e-modules, and other job aids and materials for distribution to CT&D partners and program participants.

* Skilled at group facilitation and group learning exercises.

* Implements learning and development programs based on needs assessed.

* Designs and implements metrics to measure training programs and training impact, effectiveness, appropriateness, and utility.

* Filters and distributes educational resources to CT&D partners and other appropriate audiences while remaining

contentious of legal and regulatory parameters.

* Collaborates with all CT&D partners: Sales, Marketing, Development, Medical Communications, Clinical, Legal, Regulatory, Library Services, etc. to ensure training needs are met.

* Collaborates within CT&D to ensure consistency, avoid redundancy and thereby enhance training programs.

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Manage selection, hiring and training of personnel on company and department policies, systems and processes.  Manage and communicate compensation related information per company guidelines.
• Ensure effective training program exists, improve with time, and are managed in compliance with PQS
• Ensure all employees have developmental goals and barriers removed to support attainment of goals
• Drive continuous improvement initiatives which simplify processes, enabling improvement in right-firtst-time, and appropriate prioritization of high compliance risks
• Manage and prioritize resources through IMPACT and in alignment with associated IMPACT prioritization priciples
• Ensure projects and initiatives are completed on time and within budget.
• Collaborate, influence and/or author department policies and procedures.
• At the cross-site and corporate level, provide leadership, vision and direction to:
­ address complex validation issues and influence network direction
­ develop and maintain validation programs  within cGMP regulations and the PQS.
• Monitor and control expenditures against the department budget.
• Immediately escalate potential quality or regulatory issues that may impact product quality or regulatory compliance.

Technical Duties/Responsibilities:
• Provide direction to subordinates in order to provide effective oversight of all validation systems lifecycle deliverables, per PQS.
• Interpret, implement and recommend improvements to validation policies, procedures, processes and workflows to meet quality and business objectives.
• Ensure that the Quality Leadership Team is aware of significant validation issues that may impact product quality or operations.
• Maintain and present validation systems health, representing the health of the program.
• Serve as technical and strategic resource for a range of validation assignments.
• Review and approve regulatory submissions and present validations to regulatory authorities during routine and pre-approval inspections.

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This position is responsible for providing leadership and direction to a purification process development group in Purification Development.  The candidate will lead a team of 12-18 staff comprised of several groups of scientists and engineers and be responsible for the management and leadership of multiple early stage and late stage development and technology projects.  A high degree of initiative is expected to assess new areas and directions critical for Pharma Technical Development and Genentech’s future success.  Strong management skills to lead, motivate, and develop staff in their group is a key requirement for this position.  The candidate is expected to provide leadership to their groups and throughout Purification Development and across Pharma Technical Development.

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The Sr. Finance Manager plays a pivotal role providing financial support for Global Biologics Technical Operations (PTB).  The Biologics Operations manufactures over 70% of worldwide Pharma revenue and is the primary supplier of clinical production.

This position reports to the Head of Finance – FMTB Financial Planning & Analysis and Accounting and supports the financial planning and analysis of 11 manufacturing sites in 9 locations and $2.5B of spending. 

This is a high-profile, global role that interfaces with senior management and cross-functional finance teams such as Supply Chain, Quality and Operations.  

Specific Responsibilities:

• Support forecast, budget and long range planning process for PTB, coordinating with finance teams across US, Singapore and Europe.  Produce executive updates and analyses.
• Provide support to local Genentech manufacturing finance functions in planning activities, such as financial systems interface (TM1) and process management.
• Partner with global finance teams to explain underlying business drivers on variances and alert management on risks and opportunities. 
• Consolidate, analyze and communicate financial performance for global Biologics.
• Collaborate with financial systems team to improve financial models, processes and analyses.
• Business partner with several leaders on forecasting and reporting their cost center budgets. 

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This position is part of the drug product group within Biologics Manufacturing Science and Technology (BMSAT) organization. The successful candidate will work with a team of engineers and manufacturing technical specialist responsible for fill-finish technology transfer to contract/partner manufacturing sites, as well as process transfer between Genentech/Roche manufacturing sites. The successful candidate will also be responsible for providing ongoing technical support for drug product manufacturing processes across the Genentech/Roche network.  Candidate will ensure technical stewardship across the various CMO product transfers as well as ongoing continuous improvement projects. 

• Serve as a technical lead for one or more fill-finish process transfers to contract/partner manufacturing sites, as well as between Genentech/Roche manufacturing sites.
• Provide on-going fill-finish manufacturing support to the CMO or internal manufacturing sites by performing trouble shooting, product impact assessments during deviations and investigations and process improvements. 
• Work collaboratively with the site MSAT groups, Late Stage Pharmaceutical Development groups, Manufacturing Operations, and Engineering to develop in-depth knowledge of the fill-finish processes and to facilitate technology transfers.
• Author and review technical reports, process validation documents, and portions of regulatory submissions to support licensure.
• Identify and communicate manufacturing best practices, and work to ensure manufacturing process consistency across the different fill-finish facilities.
• Lead and participate in cross-site and cross-functional teams responsible for technical oversight of drug product manufacture and process improvements, developing global standards, troubleshooting issues, analysis of cross-site process performance data and implementation of quality standards.
• Lead and/or guide the product technical teams (PTTs), serve as a member of the PTT, collaborate closely with the product supply chain, quality and regulatory lead.  Participate in Joint Management Teams (JMT) for CMO transfers for functional representation and/or team updates.

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Sr. Competitive Intelligence Manager

 

The Sr. Competitive Intelligence Manager (“CIM”) participates actively in supporting Genentech's US commercial planning efforts by providing objective, in-depth information about current and future markets and competitive forces.  The CIM acts as a strategic advisor to the US commercial teams with deep expertise in current and future competitive drivers in the marketplace as well as functional expertise in how to use CI to develop competitive strategies.

• Provide an objective commercial viewpoint based on an in-depth understanding and analysis of commercial, clinical, and scientific competitive information.  Make recommendations on brand strategy that prepare the brand for a competitive marketplace.
• Liaise with global CI counterparts to ensure up-to-date competitive intelligence and assumptions are shared with all appropriate US teams (includes congresses, news flashes, pipeline updates, therapeutic area landscape reviews)
• Collaborate with brand to plan for competitor launches by co-planning local strategy wargames and supporting rigorous competitive readiness plans.
•  Lead competitive threat assessments to develop rigorous team assumptions about key competitors; ensure local assumptions are consistent with global assumptions.
• Provide situational analysis support for quarterly business reviews, brand planning, launch readiness reviews, etc.
• Field intelligence facilitation, including managed care teams
• Work on innovative programs to increase the value of competitive intelligence processes and practice, and analyze the success of these programs.  Liase across the broader Market Analysis & Strategy organization to deliver holistic analytic insights to the brands.  Inform, communicate, and collaborate with MA&S partners.
• Manage one to two direct reports, which will include ongoing coaching and development discussions with tangible action plans for leveraging strengths and addressing areas of growth.

 

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Summary:    

 

This position serves as an important conduit within the broader organization to ensure a culture of compliance through well-thought out, actionable, aligned and achievable compliance related processes. Given the nature of the group's work, incumbent will communicate and interface with a host of internal cross-functional partners, both within gRED and other Roche functions; identifying key performance indicators, areas for improvement and ensuring compliance with current regulatory policy, legislation and guidance. The Quality Specialist will actively contribute to the development and implementation of Standard Operating Process / Procedures, tools, and templates for application in clinical research and provide and interpretative guidance of such within Clinical Operations and the broader gRED community. 

This is achieved through:

• Proactively identify and manage changes in controlled processes and procedures as the organization evolves, industry practices change and/or regulations change to assure high quality standards with applicable laws, regulations, guidelines and Roche policies.  

• Working collaboratively with all internal and external business partners and key stakeholders to assess clinical business systems and processes and provide input on any unique business requirements utilizing strong interpersonal, influencing, and negotiating skills.

• Identifying and anticipating potential problems impacting the ability to meet business goals; developing and implementing methods of improvement and resolution in a pragmatic and effective manner.

• Staying abreast of relevant laws and regulations that affect organizational quality and ability to remain in a state of regulatory compliance 

• Proactively communicating and educating others regarding such laws and regulations

Key Responsibilities:

• Partner with other departments interacting with Global & Regional functions including, but not limited to: Drug Safety, Quality Assurance/ Risk Management, PD Clinical Operations, Healthcare Law, Corporate Group & Risk Advisory, Medical Affairs to ensure appropriate cross-functional SOPs, Policies or Work Instructions are in place. 

• Facilitate SME involvement and partner with global and cross functional teams in the development, review and implementation new/updated controlled documents (Policy/SOP)

• Serve as a key contact for communicating controlled document and policy changes within/across the gRED organization 

• Provide direction, and guidance to study teams to address quality issues, concerns and or potential regulatory compliance risks       

• Participate in the development and execution of GCP, SOP or Policy related training 

• Provide support and guidance during and following internal audits and external regulatory inspections (as required).

• Provide consultative guidance on business initiatives involving new systems, processes, procedures, regulations and innovative tools for use in clinical research activities.

• Facilitate the process of continuous process improvement and support internal and global cross functional initiatives by analyzing “to be” processes; forms, templates and related process documents to ensure alignment, accuracy, and adherence to relevant internal/country/local legal and regulatory requirements.

 

• Liaise with internal stakeholders and global quality partners to ensure strategic quality risk assessments are completed and provide oversight to gRED management and personnel on contracted service providers to ensure services meet business needs (quality deliverables and alignment to regulatory requirements)

• In partnership PD Quality, identify, interpret, and disseminate quality and compliance related trends, expectations and compliance requirements to leadership and respective governance bodies. 

• Challenge inefficient processes and leverage compliance and maintain highest levels of awareness, expertise in international GxP regulatory requirements, and project-specific procedures applicable to the clinical trial methodology

• Serve as consultant to management and internal/external spokesperson for the organization on matters pertaining to its policies, quality plans, objectives and business goals

• Provide regular u...

 Purpose: 

The Genentech Research and Early Development (gRED) Clinical Program Leader (CPL) position is accountable for operational strategy for assigned early development programs. The CPL is accountable for functional management including recruiting, building and maintaining a high quality gRED Clinical Operations organization. 

Primary Accountabilities and Responsibilities: 

Program Management Responsibilities: 

Through appropriate leadership, direction and operational expertise, lead the development and execution of operational strategies for multiple molecules/programs in Genentech’s early development portfolio: 

• Represent Clinical Operations on the Early Development Teams (i.e. Core, Development or Clinical Sub-Teams) 

• Develop program timelines and budgets and manage variance 

• Provide strategic, operational input to clinical development plan (CDP), target product profiles (TPP) and project plans 

• Lead the Clinical Operations team to ensure effective development, implementation and execution of all clinical trials within agreed timelines, resources and budget 

• Develop and present operational plan to management review bodies 

• Identify program risks and develop and implement mitigation strategies for assigned programs 

• Define the resourcing and outsourcing strategy for early development programs 

• May participate in Business Development assessments 

• Work collaboratively, effectively, and efficiently with all internal and external partners and stakeholders 

• Partner with Business Management to identify strategic business needs to support the clinical programs 

• Partner with late-stage development leaders to ensure strategic alignment on the CDP 

Functional Management Responsibilities: 

Identify, recruit, hire, and develop Clinical Operations staff, as well as oversee their work to ensure all department goals, deliverables, and objectives are met. Additionally, contribute to the Clinical Operations organization. These responsibilities include: 

• Manage Clinical Operations staff including development, coaching, mentoring, performance management, and succession planning 

• Ensure that employees are appropriately trained and comply with company and regulatory standards 

• Create a positive work environment by encouraging mutual respect, innovation and accountability 

• Resource projects to enable teams to meet deliverables 

• Create and maintain Clinical Operations as a ‘great place to work’ 

• Participate in and/or lead working groups and/or initiatives within the gRED organization or cross functionally as required 

• Partner with Process and Training Management (PTM) to optimize and continually improve processes; to create and maintain role definitions and standards; and to develop role-based competency and training programs 

• Create an environment supporting innovation and smart risk to help the department continuously evolve, improve and excel *LI-EK1

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Senior Business Systems Analyst 

The Senior Business Systems Analyst will be responsible for supporting Strategic Pricing and Contracting Management (SPCM) systems planning and business process support, including contract development, contract administration and government price reporting operations. This role supports alignment of business processes and systems to provide accurate business monitoring, analytics and operational excellence across SPCM Teams.

The Senior Business Systems Analyst will be responsible for providing leadership on system projects including data analysis, user requirement gathering and documentation, business process documentation, and impact and gap analysis. They will serve as the subject matter expert for contract development, contract administration and government price reporting business processes, and the Veritas applications.

The Senior Business Systems Analyst will need to develop an understanding of the complex data environment in order to enhance standard reports, perform analysis and develop ad hoc queries and reports. This position requires the ability to retrieve data from multiple environments, identify trends, perform analysis and make recommendations. They may also lead or participate in developing data management strategies (including MCCO IT initiatives such as with the Channel, Customer and Contracting Performance, C3PI Initiative) and implementing accurate infrastructure for robust and hight-accuracy analytics. The position also requires strong written and verbal communication skills and an ability to collaborate with management and other functional groups within the Commercial organization. The data analysis will also support the SPCM Operational Excellence program that will be driven by existing and new metrics.

This position will be expected to have an up-to-date knowledge of the enterprise IT strategic direction and be able to influence IT system decisions that will be cost-effective, supportable and scalable. This will require strong leadership on projects and in the prioritization of the overall project portfolio, developing business cases and driving to maximize sIT ROI. This position reports to the Group Manager, Strategic Pricing and Contract Process and Technology.

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Job Description

The Senior Business Systems Analyst position will work in Medical Communications and is primarily responsible for but not limited to the following;

• 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
• Provides consultation to users in the area of business systems and processes
• Applies advanced technical principles, theories, and concepts related to requirements, data, usability and process analysis
• Facilitate strategic initiatives in Medical Communications/US Medical Affairs, as well as business partners across Roche/Genentech
• Conduct ongoing feasibility studies and gap-analysis for improvements through automation and/or business process changes
• Assist business function areas in understanding strategic problems, opportunities, and the big picture for the functions to make informed decisions to support the business long-term
• Propose strategic recommendations for process improvements and streamlining across the organization
• Articulate and communicate project portfolios alignment with overall business strategies to management and key stakeholders
• Assist management to report business health (success/achievements or areas requiring focus) 
• Liaise with IT to ensure accuracy and completeness in user requirements, functional requirements, technical specifications, process flow diagrams; may configure some system settings and/or options; also, partner with IT to drive implementation of technical solutions.
• 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

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Job Title: Senior Specialist (E4/5)

Department: PTQBQ Stability

Job Responsibilities:

·         Key contributor for developing consistent strategies for stability studies performed at different sites, CMOs and partners

·         Manage and monitor milestones and detail timelines for assigned commercial products to ensure the achievement of corporate goals and objectives while providing timely and transparent communication to the PMT subteams and other cross-functional teams.

·         Provide scientific rational for stability study design and propose changes for the Genentech Quality organization

·         Provide scientific and technical leadership in Inspection/ Audit situations, thinking critically and acting creatively while providing information quickly and accurately

·         Author and  provide scientific as well as technical representation of Stability in all stability relevant sections for Submissions, Regulatory Agency responses, APRs and ARs

·         Work closely with other Senior Specialists and senior management to develop strategy for long range operational and resource planning   

·         Serve as a subject matter expert (SME) for stability questions related to assigned commercial products

 

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Note: This position is posted as E3/E4 depending on skills and experience.

 

 

The job takes place in an office environment and requires computer use >4 h/day, prolonged sitting, and repetitive motion (keyboarding, mousing, etc.). Occasionally job requires lab investigation and potential exposure to a number of chemicals, including but not limited to: acetonitrile, chlorine, acids and bases, biologic toxins, microorganisms and potent compounds.

 

 

Main Purpose of the Position:

·         Provide commercial and clinical product support to ensure highest level of compliance, uninterrupted supply to patient, and continuous improvement in business processes and methods.

·         Represent Quality Control in Product Quality Teams

·         Draft Annual Product Quality Report and Annual Trend Report

·         Ensure Quality Control is ready to execute commercial & clinical manufacturing campaigns

·         Ensure effective corrective and preventive actions are systematically identified, analyzed, implemented and documented to prevent recurring problems and improve product and process quality.

·         Perform tasks and work to achieve company goals and organizational objectives.

 

Job Duties/Responsibilities:

 

• Apply extensive theoretical and cross-functional expertise in the context of company objectives to independently address complex problems
• Subject matter expert in test methodology, systems, or operational process
• Review data and assess against established acceptance criteria
• Perform technical review of data derived from complex tests, including those outside their primary area of expertise
• Evaluate data to identify trends and/or establish limits
• Identify and resolve discrepancies. Design and execute quality investigations and CAPA (corrective actions preventive actions) initiatives as needed
• Review and approve technical / investigation reports.
• Identify, troubleshoot, and solve technical problems.
• Independently identify and lead process improvements and develop resolution of complex gaps.
• Provide input to and oversight for assay transfer and assay validation
• Act as a subject matter expert for equipment qualification and maintenance requirements, as assigned.
• Assure and apply cGMP throughout operations
• Design, develop, and/or approve training material. Receive and provide training as necessary.
• Lead collaborations to support complex and/or multi-site projects
• Serve as subject matter expert in internal and external audits and regulatory inspections
• Write protocols, procedures and reports
• Meets scheduled performance of 95% on time.
• Perform other duties as requested by managers to support Quality activities.
• Interacts with senior internal and external personnel on significant matters.
• Represents organization as a prime contact on initiatives and projects.
• May provide guidance and coordinate work activities of other personnel.
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors, including inter-organizational impact.

 

Capabilities Identified for Success:

 

• Accountability
• Attention to Detail
• Communication
• Organization and Prioritization
• Policies, Process, Procedures
• Teamwork

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