The MCCO Solutions team in Genentech’s IT Americas organization is looking for a motivated Sr. Software Quality Analyst to lead all aspects of Quality Assurance and QA Testing of technology projects in support of US Commercial Operations.  The Sr. SQA will be responsible for managing the work of assigned Quality Assurance (QA) resources, effectively building and tracking QA Plans and Strategies, and ensuring end-to-end quality in all phases of the project lifecycle.  

Duties:

• Plan and execute functional, performance and stress testing on applications and systems using automation and manual testing
• Maintain an understanding of leading tools and technologies for development of mission critical web, database and related applications. (Mercury Suite, Selenium, Segue, etc)
• Lead the development of SQA Test Plans, Test Procedures, SQA lab standards and tool requirements
• Identify opportunities for process improvements that streamline development activities while minimizing risk
• Mentor other team members in testing processes & testing tools in order to execute Test Plans as required
• Manage work of onsite and offshore SQA testers as required 

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.

The Clinical Pharmacology Department at Genentech, Inc. is seeking a Ph.D. level Associate Scientist or Scientist who is driven to understand the clinical pharmacokinetics and pharmacodynamics of novel drug candidates in the area of Biologics.  This individual will be primarily responsible for the clinical pharmacology activities of Biologics in clinical development. This person will have responsibility for the Clinical Pharmacology strategy in order to ensure that appropriate dose/route/schedule decisions are made using the state of the art modeling and simulation strategies that are aligned with project needs. This will be accomplished by working in close partnership with Clinicians, Biostatisticians, Clinicians and project teams.  Responsibilities will include planning and reviewing study designs, analysis plans, data analysis, interpretation of PK/PD as well as planning, implementation and organization of regulatory filings (worldwide) and presentation of data at cross-functional teams, department meetings, conferences and regulatory meetings (worldwide). Additionally this individual will also be directly involved in leading project sub-teams and representing the function at cross-functional project teams.

This position may be filled at the Sr. Business Systems Analyst or Principal Business Systems Analyst level.
 
The Sr./Principal Business Systems Analyst position is dedicated to business process analyses, design and optimization to enable the routine delivery of exceptional performance. This position sits within the MCCO Data Governance and Management (DG&M) department, which is charged with assisting the Strategic Pricing & Contract Management (SPCM) organization to achieve its goals and objectives.
 
This individual will be responsible for leading cross-functional process improvement projects, representing the department as the change agent, partnering with customers, leading internal efforts within the team, communicating and coordinating with key stakeholders, resolving conflicts within the team, and delivering real value-add sustainable cross-functional solutions. This individual will mentor project team members and staff in industry best practices, process improvement methodologies, and will be accountable for following/improving upon the methodology in alignment with Genentech values and behaviors.
 
This position will lead cross-functional project teams to:

•  Implement practical and sustainable business processes
•  Maintain department scorecards
•  Update and prioritize multiple project portfolios
•  Deliver project goals on budget and on schedule
•  Analyze business, process and systems performance, and identify improvement opportunities
•  Identify opportunities for team members to develop, evaluate and manage business case and cost/benefit analyses
•  Make recommendations to Senior Management based on business case and analyses
•  Lead decision making support and make recommendations regarding best options
•  Communicate proactively with stakeholders and senior management regarding progress, issues and plans for resolution
•  Develop and use project plans to coordinate participants and track and report progress
•  Leverage industry research and analysis
•  Serve as advocate, mentor & role model for integrating best practices into the organization
•  Ensure improvement methodology and tools are utilized effectively to maximize benefits
•  Operate with a high degree of autonomy and professionalism; successfully prioritize workload in accordance with business goals

Regulatory Program Management is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Roche’s global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. Like others in Regulatory Program Management, Program Directors are assigned their responsibilities by therapeutic area, and are assigned projects for different product development phases, as business needs dictate. Regulatory Program Management Program Directors provide regulatory leadership for one or more regional or global development projects. Regulatory Program Management Program Directors are responsible for the development and implementation of regulatory strategies to facilitate the development and approval of Roche medicines for human use. Program Directors are expected to lead more complex projects and represent PDR to cross-functional teams and groups with increased independence. Regulatory Program Management Program Directors are responsible for working cross-functionally and coordinating regulatory-related activities across PDR functions and with other internal partners.  Regulatory Program Management Program Directors serve as the principal interface with primary reviewers from health authorities and for other interactions with relevant regulatory-related external parties; managing the strategies for and execution of these interactions.

DUTIES & RESPONSIBILITIES:

• Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.  Briefs teams and management, as appropriate
• Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices
• Provides regulatory expertise and leadership to site, regional or global cross-functional teams and other groups
• Stays abreast of therapeutic area product development and other related business strategies and plans 
• Serves as the primary PDR representative on one or more regional or global projects at any one point in time; typically complex projects
• Analyzes data, the regulatory environment and business objectives to recommend priorities
• Leads teams in developing, implementing and delivering the cross-functional regulatory strategy for each project or related assignment.  Plays a lead role in helping ensure effective balance of time, cost, quality and risk so that regulatory strategies meet the needs of patients, prescribers, payers, regulators and Roche
• Plays a key role in assuring business objectives are understood and taken into account during regulatory strategy development
• Identifies and aligns cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment
• Works with others to ensure timely and appropriate cross-functional alignment and appointment to RAFT for each assigned project
• Presents and obtains approvals for the cross-functional regulatory strategy to various teams, committees and senior management
• Serves as the site, regional or global principal interface with primary reviewers from regulatory authorities or for other regulatory-related interactions with other external parties. Establishes effective working relationships with regulatory authorities and directs regulatory interactions for internal site, regional and/or global teams
• Provides internal teams with direction on regulatory authority interactions
• Manages ongoing RAFT meetings. Including providing ongoing leadership of regulatory deliverables and guidance on compliance, timing and other relevant matters.  Manages RAFT resources
• Ensures cross-functional perspectives and expertise are incorporated into regulatory plans prior to decisions being made
• Manages decision-making and conflict resolution surrounding regulatory issues within cross-functional teams, including coordination between other business teams and RAFT team. Ensures appropriate escalation to team leaders or functional management, as necessary 
• Oversees, coordinates and provides a first-line of internal approvals for regulatory submissions and other relevant regulatory documentation
• Responsible to ensure all PDR deliverables associated with each project or other assignment are completed within defined timelines and...

The Advisor PEM advises and supports the Medical Unit Head of Operations. The Advisor PEM has the operational responsibility for the performance of assigned Medical Teams. This is a leadership role with responsibilities for providing input into design, development and execution of post-marketing activities; supporting medical teams in the mitigation of risks and the delivery of successful outcomes.  Advisor PEMs are assigned PEM responsibilities for multiple and/or complex or large-scale multiple molecules/products with potentially multiple indications. Advisor PEMs are also expected to take a leadership role in gMed initiatives, when needed, act as a substitute for his/her manager, assist his/her manager and others with on-boarding, training and coaching new PEMs, and if appropriate, have 1-2 direct reports.

Responsibilities:

The areas of major responsibility include, but are not limited to the following:

• Responsible for the day-to-day operations of the designated Medical teams.

o Works closely with medical directors and other cross-functional partners /teams to support the development of short and long-term medical strategy, plans, tactics, budgets and other resource plans for multiple and/or large-scale or highly complex molecules

o Co-leads and facilitates all medical team planning and decision-making

o Identifying and initiating problem solving strategies when operational issues arise and escalates issues if unresolvable.

o Plays a lead role, working with finance, legal and other partners to evaluate medical plans, develop budgets and determine any legal or other administrative implications or requirements necessary to execute projects.

o Works with team members and other stakeholders to ensure alignment of gMed strategies, plans and objectives with Genentech strategies.

o Co-leads process to develop the medical plan vision, strategy, scope, milestones, risk assessment and management strategies, project investment requirements and success metrics 

o Supports medical directors and/or plays a lead role in development and delivery of critical presentations to communicate, obtain inputs into and approval for medical plan strategies, objectives, tactics and resource requirements 

o Works with cross-functional medical team members and other partners/stakeholders to implement project plans to ensure timely, on-target, and within-budget execution

• Builds and maintains relationships with key internal/external customers, partners and other stakeholders, includes global partners, external strategic partners, etc.

• Works with manager and other team members on key departmental projects, including standardized gMed and/or MU specific Planning & Execution SOPs, other protocols, processes, systems, tools, etc. 

• Oversees all project/program phases to help ensure on-time, on-target and within-budget execution 

• Conducts proactive risk assessment and change control for all assigned projects/programs

• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

The DAS is responsible for the specifications, acquisition, loading and delivery of non-CRF data including IxRS, laboratory, pK and other data.

Responsible for the production of non-CRF data collection specification documentation 

Defines the study specific non-CRF data handling strategy

Collaborates with SMT to agree on vendor expectations for the collection and transfer of data 

Reviews and refines the technical requirements with service provider to establish the transfer of non-CRF data  

Responsible for establishing appropriate transfer methodology with external data provider

Provides transfer methodology training and documentation on non-CRF data for external vendors.

Responsible for configuring the data loading tools based on data collection specifications

Receives, uploads, confirms and communicates status of test data transfers to validate and accept file format and database structure

Performs verification and resolves data transmission, file format and loading errors with data providers  

Proactively checks all inbound non-CRF electronic data for any potentially unblinding data as defined in the protocol and ensures study integrity by sequestering unblinding data until data release is authorised

Delivers data to external recipients and review bodies via established transfer methodologies

Represent CDM on IxRS sub teams and works with the Study Management Team to develop IxRS specifications and implement the system

Coordinates and plans subfunction activities to meet program-level deliverables and timelines

Develops and maintains the subfunction standards for the studies in a program

Collaborates with Data Modeling Specialists to define study data collection standards for new assessments and collaborates with them to implement new standards

Effectively communicates ideas, project goals and status of work and can present to senior management 

Proactively develops solutions to complex problems requiring the regular use of ingenuity and innovation

Sets targeted timeframes for  deliverables and anticipates potential scenarios that may result in timeline delays; able to influence and negotiate a positive outcome

Proactively develops contingency plans to reduce impact of risks that may occur, to analyze effectiveness of strategies and to monitor and review risks 

• Adhere to all applicable compliance and safety requirements, cGMPs, SOPs, and other manufacturing documents
• Lead efforts to provide on-going technical support for production at internal and external contract and partner sites. Includes monitoring process performance, resolving manufacturing deviations, participating in quality investigations, and providing technical approval of document and automation recipe changes to support continuous process improvement
• Lead and/or participate in global initiatives and cross-functional investigational and project teams
• Work collaboratively with site Manufacturing Science and Technology (MSAT) groups to develop and communicate best practices for process and equipment design and operation to ensure consistency and compliance across the biologics manufacturing network
• Support product impact and root cause assessments for process discrepancies and Quality investigations
• Travel within the Roche network and to contract manufacturing sites will be required
  

The DMPK group is dedicated to enabling the discovery, developmentand commercialization of safe and effective medicines by elucidating theabsorption, distribution, metabolism, excretion and pharmacokinetic propertiesof small molecule drug candidates. We accomplish this through the applicationof state of the art technologies and sciences of bioanalysis, drug metabolism,drug transport and pharmacokinetics. The DMPK group works in close partnershipwith disciplines such as medicinal chemistry, pharmacology, toxicology,pharmaceutical sciences, clinical pharmacology and regulatory to optimizeleads, select clinical candidates, conduct preclinical development studies,support clinical evaluation and contribute to IND and NDA filings.

We are seeking a candidate to support both in vitro and in silicoADME.  The candidate will work with anestablished team on various in vitro assays and will collaborate with otherscientists in the group to perform hypothesis-driven studies to address ADMEquestions.  On the in silico side, thecandidate will apply ADME models to support projects and maximize the value of existingADME data. They will work at the intersection of modeling ideas, modelgeneration and experimental investigation to support/build SAR and meet projectneed.  A key part of the role will becontinuing education in the department on use of predictive DMPK and championinguse of in silico tools. The candidate will be a highly effective and energizingcollaborator and will work scientists from multiple disciplines including computationaland medicinal chemistry, safety assessment and pharmaceutical sciences.

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

The AE&O Senior Project Manager scopes, plans and manages local, regional and global IT projects consisting of one or more delivery streams. He/she works with solution owners and project sponsors within AE&O (Architecture, Engineering & Operations) and SP&A (Shared Platforms & Applications).

As part of a team of project management professionals he/she reports to one of the Team Leads of Project Management within AE&O Project & Portfolio Management and is supported by portfolio analysts of the AE&O PMO and SP&A PMO (if applicable).

The Senior Project Manager is responsible for scoping, planning, managing and controlling global IT projects and reporting in a timely, accurate and transparent manner following standardized methods to allow accurate portfolio management and project execution control within AE&O and SP&A.

The senior project manager works closely with a responsible portfolio analyst from the PMO in AE&O (or SP&A) to ensure timely and accurate project reporting on project scope, schedule, cost and resources, as well as project risks, issues, action items, and dependencies.

In addition the senior project manager needs to collaborate closely with the Finance, Quality & Procurement departments as required. Also the involvement of other Pharma IT areas outside of AE&O and SP&A (as internal project workforce) might be required (e.g. Roche’s Shared Service Center in Warsaw).

Major Responsibilities include:

• Project Scope Management - Formulating and defining scope and objectives of the project in collaboration with the responsible Solution Owner and ensuring communication of project goals, schedule baselines, and business direction to all identified stakeholders
• Project Stakeholder / Communication Management - Identifying all relevant project stakeholders and establishing and implementing an appropriate communication plan to manage their requirements
• Project Delivery Primarily - Delivering the project on time, on approved (baseline) budget, within quality limits, and with the expected benefits, as defined at project entry and project baseline gates and through controlled and documented change management throughout project delivery, as needed
• Project Risk, Assumption, Issue and Dependency (RAID) Management - Actively managing risks, assumptions, issues and dependencies (RAID) by carefully assessing potential impacts in collaboration with the respective project teams and proposing appropriate mitigation actions. Is also responsible for identifying, actively managing and integrating with any dependent projects or activities.
• Project Planning, Tracking, Control & Reporting - Creating baseline project schedules and tracking the completion of project deliverables, tasks, activities and milestones. Providing accurate, timely and fit for purpose project status reports using established norms and reporting tools of the portfolio
• Team Building & Leadership - Organizing and supervising the appropriate involvement of project resources and actively managing and addressing the resolution of conflicts within the project team.
• Compliance – Directly accountable for ensuring compliance with project management, portfolio management and CSV policies, guidelines, process tools and reporting standards of the portfolio. These norms will include all system qualification/validation state documentation, project documentation and resource forecasting/tracking, financial forecasting/tracking and governance procedures of the portfolio for the specific projects assigned

This South San Francisco, CA-based position has the responsibility for operations support of all Pharma and Diagnostics Contact Center infrastructure in the North America (NA) region.  This includes 39 contact center groups across two (2) main campuses and six (6) additional sites, handling over 5 million calls in addition to a large number of fax, email and other interactions per year.  This individual is a thought leader and strategist and will have a deep understanding of contact center technologies and processes.  He/She will work on unusually complex technical problems and provide solutions, which are highly innovative and ingenious. This individual will serve as technical lead on large-scale enterprise project teams, that will transform how our contact centers are currently doing business. He/She will work with IT Architecture to evaluate and analyze emerging technology associated with delivery of voice calls and other interaction channels and corresponding data as well as influence the development of contact center roadmaps and strategies in order to meet the business needs within the NA Region. It is critical that this person understand the individual needs of each line of business within the NA Diagnostics and Pharma contact center business units.  This position requires a solutions-oriented individual who can be dedicated to serving the business by leveraging technical expertise, strategic planning, clear business understanding and excellent communication and collaboration skills to deliver first-class voice and contact center infrastructure and support.

This position will help consolidate the current disparate NA Contact Center solutions into a single regional, centrally supported platform that will meet the current and future needs of the business.

You will have the following key responsibilities:

• Operate as the SME and process owner for Contact Center Solutions in NA
• Key contributor in strategic planning and development of annual goals, budget and objectives for NA Voice Services
• Key contributor to TAF Roadmap and technology for NA Enterprise Voice and Contact Center systems and related solutions
• Collaborate with architecture and engineering on technical aspects of Telephony and Contact Center infrastructure and solutions
• Work with the Global Head of Voice Services and appropriate team members to define, develop and implement Global, Regional, and local standards and SOPs 
• Provide leadership and visibility for Voice Services NA Region within the Global IT Architecture, Engineering & Operations organization 
• Provide deep technical expertise over a broad set of current technologies and mentoring of other team members in these areas
• Create collaborative partnerships across IT and the business
• Ensure regular on-going communication is happening in all areas of responsibility with critical stakeholders to create awareness and set expectations 
• Act as an advocate and serve as a trusted advisor to the business
• Work with Commercial Marketing on FDA Drug approvals and launches and new programs and special toll free number assignment 
• Work closely with the business to understand portfolio and prioritization of business requirements
• Develop and maintain clear project process and engagement models and communicate through proper channels to ensure alignment with the business for successful implementation and delivery of contact center projects
• In an operational setting, oversee the deployment of software enhancements, troubleshoot production systems, ensure root cause analyses (RCA) is performed for all outages and adheres to established SLAs all while providing excellent customer service
• Provide leadership, vision and mentoring to the Voice Services and Telecom vendor on-site staff
• Monitor legal and regulatory compliance of all voice systems, including adherence to HIPPA and California State standards for voice systems 
• Participate in leadership activities to promote the achievement of all goals and objectives
• Look for new opportunities for infrastructure consolidation and centralized management

The Network Services Operations team is responsible for project deployment and 24x7 operations support of our North America enterprise wired and wireless networks which serve over 22,000 users and are comprised of wireless access points, switches, routers, firewalls, load balancers, proxies, VPN concentrators, and optical network devices.  

We are looking for a results-driven analytical thinker with strong technical and process management skills who can provide imaginative, thorough, and practicable technical solutions to a wide range of difficult problems.  This person will work closely with our architecture and engineering teams as well as vendors to maintain 99.99% availability while successfully deploying emerging network technologies to new and existing Genentech buildings and data centers.

Candidate must have good business acumen and possess strong communication and teamwork skills.  We are looking for an individual with strong time management skills who can work autonomously making sound decisions that are consistent with organizational objectives.  You must have a proven track record for delivering excellence thus enabling us to meet the scientific demands of our biotechnology revolution in information technologies.

This positon may be filled at an Associate Contract Manager or Contract Manager  level.

The Managed Care Contracts Group manages the contracting process from development of an account-centric contract strategy through execution of an agreement. The Associate Contract Manager, Managed Care Contracts develops, drafts, analyzes, negotiates and gains the necessary approvals for the assigned managed care accounts and contracts.

• Works closely with Contract Managers and other internal partners in reviewing customer contract needs, requirements, etc. in alignment with GNE contracting strategies, business objectives, and other contract conditions
• Conducts various analyses and modeling of appropriate contract terms and reviews with key internal partners/stakeholders
• Obtains all appropriate and required internal reviews and approvals for contract terms and provisions
• Develops language and drafts contracts and related documentation
• Responds to various partner/stakeholder questions, inquiries, requests for clarification, etc. regarding contracts and terms/conditions or other items
• Ensures execution of approved and finalized customer contracts; including timely and accurate hand-off to other internal partners/stakeholders
• Monitors existing customer contracts using approved performance methodologies, tools, etc.; includes identifying and recommending opportunities for improvement
• Ensures all contract data and information is appropriately entered into relevant systems/databases
• Complies with all laws, regulations and policies that govern the conduct of GNE activities
• Business travel, by air or car, may be required for regular internal and external business meetings

The AE&O Senior Project Manager scopes, plans and manages local, regional and global IT projects consisting of one or more delivery streams. He/she works with solution owners and project sponsors within AE&O (Architecture, Engineering & Operations) and SP&A (Shared Platforms & Applications).

As part of a team of project management professionals he/she reports to one of the Team Leads of Project Management within AE&O Project & Portfolio Management and is supported by portfolio analysts of the AE&O PMO and SP&A PMO (if applicable).

The Senior Project Manager is responsible for scoping, planning, managing and controlling global IT projects and reporting in a timely, accurate and transparent manner following standardized methods to allow accurate portfolio management and project execution control within AE&O and SP&A.

The senior project manager works closely with a responsible portfolio analyst from the PMO in AE&O (or SP&A) to ensure timely and accurate project reporting on project scope, schedule, cost and resources, as well as project risks, issues, action items, and dependencies.

In addition the senior project manager needs to collaborate closely with the Finance, Quality & Procurement departments as required. Also the involvement of other Pharma IT areas outside of AE&O and SP&A (as internal project workforce) might be required (e.g. Roche’s Shared Service Center in Warsaw).

Major Responsibilities include:

• Project Scope Management - Formulating and defining scope and objectives of the project in collaboration with the responsible Solution Owner and ensuring communication of project goals, schedule baselines, and business direction to all identified stakeholders
• Project Stakeholder / Communication Management - Identifying all relevant project stakeholders and establishing and implementing an appropriate communication plan to manage their requirements
• Project Delivery Primarily - Delivering the project on time, on approved (baseline) budget, within quality limits, and with the expected benefits, as defined at project entry and project baseline gates and through controlled and documented change management throughout project delivery, as needed
• Project Risk, Assumption, Issue and Dependency (RAID) Management - Actively managing risks, assumptions, issues and dependencies (RAID) by carefully assessing potential impacts in collaboration with the respective project teams and proposing appropriate mitigation actions. Is also responsible for identifying, actively managing and integrating with any dependent projects or activities.
• Project Planning, Tracking, Control & Reporting - Creating baseline project schedules and tracking the completion of project deliverables, tasks, activities and milestones. Providing accurate, timely and fit for purpose project status reports using established norms and reporting tools of the portfolio
• Team Building & Leadership - Organizing and supervising the appropriate involvement of project resources and actively managing and addressing the resolution of conflicts within the project team.
• Compliance – Directly accountable for ensuring compliance with project management, portfolio management and CSV policies, guidelines, process tools and reporting standards of the portfolio. These norms will include all system qualification/validation state documentation, project documentation and resource forecasting/tracking, financial forecasting/tracking and governance procedures of the portfolio for the specific projects assigned