Sr. Strategy Manager

The Sr. Strategy Manager, Strategic Pricing & Contracting develops pricing and contract strategies for the assigned segments that optimize the value of Genentech’s portfolio, which includes leading cross-functional segment strategy development teams, building effective relationships with account core teams, internal teams across MCCO (Managed Care & Customer Operations), scenario analysis/modeling for overall financial and legal viability, and ongoing pricing and contract performance assessment/analysis.

This opening would be primarily focused on leading launch preparations for octreolin, a recently in-licensed compound for the treatment of acromegaly. Acromegaly is a disease affecting 20,000 people in the US. This is a long-term condition in which there is too much growth hormone present resulting in body tissues enlarging over time, ultimately leading to various co-morbidities and a shorter lifespan. We are excited about this opportunity for Genentech as we feel that octreolin could represent a significant advance for patients with this devastating condition. The potential launch timing is Q1, 2015.

This supervisor role would oversee the Growth Franchise (Nutropin and Octreolin) and will have one or more direct reports and will also share some of the other departmental management activities with their manager, e.g., reviewing the work of other managers, developing training/development programs and initiatives for team members, preparing and delivering senior management presentations on strategic or complex issues, leading strategic projects, etc. Given the nature of this group’s work, most management and staff in this department have considerable responsibilities for regular communications, interactions, coordination and development with partners in the broader Roche organization, and communicating with, influencing, and securing approval from senior management.

• Typically manages pricing activities and contract strategy performance analysis for more complex, high-volume or high strategic value products
  • Participates in various Genentech business planning meetings and processes
• Regularly leads strategic pricing & contracting analysis and assessment for the assigned segments, franchises and products across all stages of the lifecycle
• Acts as segment subject matter expert for assigned account segments
• Works closely with Account core teams to devise appropriate strategy for decision-making, terms and negotiation.  Executes all needed analytics to influence MCCO Governance or related field leadership teams on winning strategies
• Stays abreast of macro trends in the healthcare environment that could potentially impact pricing and contracting opportunities and/or risks
• Conducts or commissions market research and competitive analysis working with other internal or external partners as necessary
• Develops detailed quantitative and qualitative analyses and modeling of pricing and contracting strategies and recommendations
• Synthesizes market and business analytics in presentations and communications
•  Works with brand pricing and contracting strategy leads to align brand or overall segment strategy with account-based needs
•  Tracks and communicates all relevant pricing and contracting trends and issues in assigned segments to internal partners/stakeholders
•  Prepares internal reports and presentations and reviews with key internal partners/stakeholders; has frequent presentations to senior management
•  Identifies and recommends metrics to assess pricing and contracting strategy effectiveness for all assigned segments
•  Tracks and monitors account performance, including post-hoc analysis of account level strategy and implementation results
•  Works closely and collaboratively with a host of internal partners/stakeholders including, but not limited to operations departments to understand operational considerations and constraints related to strategies and representing this input to the core teams
•  Recommends on contract group clustering to ensure appropriate consistencies as well as provide maximum leverage, efficiencies, and effectiveness
•  May support manager in building pricing and contracting models and other tools for department-wide analysis and assessment
• Translates research, analysis and modeling into documented pricing and contracting strategies.  Works with manager to ensure integrated cross-segment consistencies and efficiencies
• Evaluates immediate-, medium- and longer-range business and financial impacts of pricing and contracting strategies
• Identifies and supports others in planning for operational and tactical requirements to support pricing and contracting strategies for existing, new, in-line and/or pipeline stage products
• Partic...

Product Manager or Sr. Product Manager - Launch Strategy - Bio-Oncology 

This position is in the Managed Markets Launch Strategy group within Managed Care Marketing (MCM). MCM supports Genentech’s business by designing managed care marketing strategies, plans and tactics that enable Genentech’s goals to be met across US managed care segments (payers, channels, practices). Managed Markets Launch Strategy develops, implements and manages the managed markets marketing strategy, plan and tactics for Genentech’s pipeline. The team supports molecules as early as Phase II drug development, and involvement extends to approximately 6 months post-launch. Each Senior Product Manager has the opportunity to work on molecules at various stages of development.

Key activities for this role include:

• Representation of Managed Care Marketing in product launches. Builds, implements and manages the managed care marketing launch plans, including market readiness activities, launch readiness reviews, account segmentation, key message development, promotional development, field training, and competitive readiness (if relevant for pipeline products).  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. Creates and manages appropriate marketing budgets. Ensures appropriate and timely implementation of approved managed care marketing plans and tactics under his/her responsibility
• Coordination of overall Managed Care and Customer Operations (MCCO) pre-launch activities. Leads MCCO launch team to drive cross-functional alignment and support creation of strategies, plans and activities that support optimal formulary positioning, reimbursement, access and overall market share. Provides managed care perspective to Brand and other partners, participates in Brand-led launch core team, launch readiness reviews, leadership updates, etc
• Strategic planning for relevant molecules to contribute to Phase III drug development investment decisions, trial design, and overall value proposition. 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. US and Global cross-functional partners include health economics, pricing & contracting, market planning, competitive intelligence and government affairs
• Expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year strategies and tactical plans. Participation in US Commercial pipeline and launch teams as well as international payer strategy teams (IPSTs)
• Contribution to creating a center of excellence for launching new molecular entities (NMEs) and line extensions, where appropriate, in managed markets, by consolidating all pipeline activities into one group
• Compliance with all laws, regulations and policies that govern the conduct of GNE activities
  

Product Manager / Sr. Product Manager – Managed Markets Launch Strategy, Growth Disorders

This position is in the Managed Markets Launch Strategy group within Managed Care Marketing (MCM). MCM supports Genentech’s business by designing managed care marketing strategies, plans and tactics that enable Genentech’s goals to be met across US managed care segments (payers, channels, practices). Managed Markets Launch Strategy develops, implements and manages the managed markets marketing strategy, plan and tactics for Genentech’s pipeline. The team supports molecules as early as Phase II drug development, and involvement extends to approximately 6 months post-launch.

PM/SPMs in the Managed Markets Launch Strategy group are generally responsible for multiple molecules at various stages of development. This opening would be primarily focused on leading launch preparations for a compound treating a growth disorder, which could represent a significant advance for patients.

Key activities for this role include:

• Execution of Managed Care Marketing deliverables for product launches. Builds, implements and manages the managed care marketing launch plans, including market readiness activities, launch readiness reviews, account segmentation, key message development, promotional development, field training, and competitive readiness (if relevant for pipeline products).  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. Creates and manages appropriate marketing budgets. Ensures appropriate and timely implementation of approved managed care marketing plans and tactics under his/her responsibility
• Coordination of overall Managed Care and Customer Operations (MCCO) pre-launch activities. Leads MCCO launch team to drive cross-functional alignment and support creation of strategies, plans and activities that support optimal formulary positioning, reimbursement, access and overall market share. Provides managed care perspective to Brand and other partners, participates in Brand-led launch core team, launch readiness reviews, leadership updates, etc.
• Strategic planning for relevant molecules to contribute to Phase III drug development investment decisions, trial design, and overall value proposition. 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. US and Global cross-functional partners include brand marketing, health economics, pricing & contracting, market planning, competitive intelligence and government affairs
• Expert managed care marketing insights and perspectives into long-range business plans and other relevant 3-year and 1-year strategies and tactical plans. Participation in US Commercial pipeline and launch teams as well as international payer strategy teams (IPSTs)
• Contribution to creating a center of excellence for launching new molecular entities (NMEs) and line extensions, where appropriate, in managed markets, by consolidating all pipeline activities into one group
• Compliance with all laws, regulations and policies that govern the conduct of GNE activities
  

This position may be filled at a Contract Manager  or Sr. 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 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 partners in field Account Management across MCCO Channel and Payer Field teams as well as GNE Government Affairs, 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
• As needed, supports field Account Management partners in negotiating contract terms and conditions
• 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
• Helps garner maximum return on investment and customer satisfaction from all contract responsibilities
• 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 Genentech activities
•  Business travel, by air or car, is required for regular internal and external business meetings
  

Contract Services Manager 

Contract Services Managers are responsible for contract services (including contract set-up, membership and affiliation assignment and maintenance) and/or customer payments in accordance with accuracy and compliance requirements. Customer payments may include responsibilities, as assigned, for processing fees, rebates, discounts and chargebacks, as per the terms of each contract. Additionally, Contract Services Managers act as subject matter experts (SMEs) on SPCM Contract Operations processes, collaborating with Contract Operations partners and stakeholders in various meetings, initiatives and projects. Expertise in the processes, calculations, systems and Standard Operating Procedures (SOPs) that support contract services and customer payments is critical to success in this position. Contract Services Managers, by comparison to Associate Contract Services Managers, also have responsibilities for developing complex analyses and reports, reviewing from the work of less experienced team members, performing contract set-up and structure for other team members, managing Internal Control Over Financial Reporting (ICFR) tracking and monitoring activities, and leading projects to improve processes and procedures.

• Acts as a lead SME for assigned contracts, other activities, SPCM Contract Operations systems, processes and SOPs
• Plays a lead role in cross-functional initiatives involving new/updated pricing and contracting strategies, terms, conditions, language and the like 
• Proactively seeks out complex information on changes in laws, regulations and other external factors and dynamics. Works with manager and other internal partners/stakeholders to interpret the information and assess its effect on current contracting models, pricing, discounts, rebates, chargebacks, compliance and the like. Develops appropriate responses, including recommending changes in complex pricing and contracting strategies, programs and contract administration
• Plays a lead role in development, education, communication, implementation and ongoing maintenance of Contract Operations SOPs, systems, processes, data, reporting templates and the like. Includes serving as a liaison for technology-related projects to ensure systems or enhancements are designed to meet the operational needs of Contract Operations and supporting testing for new or updated systems 
• Works with manager and others to establish appropriate performance metrics for monitoring, evaluating and reporting on contracts, contract performance and other business, legal and regulatory requirements
• Plays a lead role in development and delivery of Contract Operations training; including conducting training for other staff members and, as appropriate, others outside of the department
• As assigned, leads or otherwise participates in and supports other special projects
• As assigned, may perform some or all of the following:
• Enters contract information into departmental systems and databases Performs contract set-up and maintenance. Includes 340B Program Integrity support and assigning customers to appropriate contract groupings and class of trade (membership and affiliations), coordinating and managing contract term reviews
• Collaborates with other departments to determine appropriate pricing eligibility for new managed care customers; identifying customer entities, class of trade and appropriate contract pricing
• Implements departmental changes arising from such things as complex pricing strategies, updates to operating procedures, or internal policies affecting Contract Operations
• Uses relevant contract terms, conditions and other regulations, policies, etc. as well as appropriate systems and tools to evaluate, calculate, validate and process customer payments 
• Prepares payment packets as per the terms of each assigned contract. Ensures packets are routed through to all appropriate partners/stakeholders for review and approval
• Works with Customer Finance and other partners/stakeholders to track customer payments and ensure accurate and timely payments are made to customer accounts. Helping ensure penalties are avoided 
• Develops and evaluates contract performance using approved financial modeling templates
• Completes ICFR tracking and reporting, as per business and legal requirements and departmental policies & procedures
• Prepares, obtains approval for and ultimately publishes departmental scorecard reports, customer business review reports, various compliance and other ad hoc reports
• Performs ongoing membership and affiliate maintenance. May include updating membership/affiliation on an exception basis in accordance with business rules 
• Responds to questions/inquiries; may include policies, pricing, payment calculations, contract performance, complianc...

This position  may be filled at a Strategy Manager or Sr. Strategy Manager level. 
 

The Strategy Manager is responsible for maximizing the value of Genentech's portfolio through the development of integrated pricing and contracting strategies for a specific therapeutic area or product(s). The role involves leading cross-functional strategy development teams, building effective relationships across all GNE franchises, scenario analysis/modeling for overall financial and legal viability, as well as ongoing contract performance assessment/analysis. Position involves extensive cross-functional collaboration with brand teams, Market Planning, MCCO Account Managers, Government Affairs, Health Economics and Global Pricing and Payer Planning.

• Conducting detailed analysis and constructing presentations to support recommendations to senior management on specific pricing actions for new and in-line products.
• Provides a leadership perspective on GNE pipeline pricing assessments for inclusion into payer planning activities, revenue forecast development, and decision-making.
• Works with internal/external partners/stakeholders to conduct regular market research
• Evaluating macro-trends in the healthcare environment that could potentially impact pricing and contracting opportunities and/or risks
• Provides business partners/stakeholders with in-depth analyses, modeling and optimal scenarios needed to determine the best contracting strategies to meet GNE objectives
• Works closely with partners in field Account Management to understand payer/channel customer needs, expectations, challenges, etc.
• Complies with all laws, regulations and policies that govern the conduct of GNE activities

Associate Calculations Manager

Associate Calculations Managers support the calculation of complex government pricing calculations to determine government pricing in accordance with strict accuracy targets, timelines, laws, regulations and Government Pricing & Reporting’s (GP) methodology. Associate Calculations Managers also support the peer review process and are responsible for supporting government contracting.

• Acts as a subject matter expert on government contracting, pricing, pricing calculations and reporting
• Participates in the development, education, communication, implementation and ongoing maintenance of Government Calculations Standard Operating Procedures (SOPs), systems, processes, data, reporting templates and the like. Supports development and maintenance of effective GP systems; including suggesting business requirements, potential enhancements and, when applicable, supporting testing processes for new or updated systems
• Creates and implements standard reports
• Supports development and implementation of Government Calculations-specific training; including conducting training for other staff members
• Responsible for ongoing and consistent adherence to all applicable laws, regulations, corporate and business unit standards  Develops and cultivates professional relationships internally and externally
•  Ensures proactive and regular communication with internal and external partners/stakeholders
• Administers federal government contracting; including IFF, VMI and FSS
• Performs assigned government calculations to ensure timely and accurate completion; including monthly and quarterly AMP, BP, ASP, NFAMP/FCP, PHS and state reporting
• As assigned, supports BP restatement processes
• Validates accuracy of calculations for appropriate government pricing
• Enters relevant data and information into respective departmental/company systems and databases
• Ensures pricing calculations are routed through to appropriate stakeholders and partners for further review, approval and processing  
• Collaborates with Finance and others to reconcile monthly direct sales following prescribed guidelines and timelines; ensuring that any data integrity issues are resolved prior to beginning government pricing calculations
• Prepares and delivers monthly/quarterly data submissions to various internal and external parties, such as government agencies, to meet all compliance and reporting requirements
• Prepares, obtains approval for and ultimately publishes various departmental scorecard reports, customer business review reports, various compliance and other ad hoc reports
• Responds to questions/inquiries regarding assigned government programs and payers
• Reviews the work of less experienced staff members and coaches them on how to administer government contracts, perform and validate government calculations; including explaining SOPs and other requirements
• Supports internal and external audits
• May train and educate others outside of the department in departmental systems, processes, data, reports and the like
• Complies with all laws, regulations and policies that govern the conduct of GNE activities

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

This position may be filled at an Audit & Analytics Manager, Contract Services or a Senior Audit & Analytics Manager, Contract Services

Audit/Senior Audit & Analytics Managers play a leadership role in assuring Contract Operations full and consistent compliance with business, legal and regulatory requirements that govern contract services and customer partners for all commercial and relevant government programs and contracts. Audit & Analytics Managers perform internal audits and manage external contracted customer and 340B entity audits. In addition, Audit & Analytics Managers gather, analyze, synthesize and provide partners and stakeholders with compliance and audit related-data to support ongoing business operations and decisions, which includes identifying and interpreting trends that emerge from internal and external audits and communicating these findings and implications to partners/stakeholders. Given the nature of their work, Audit & Analytics Managers act as subject matter experts (SMEs) on SPCM Contract Operations processes, collaborating with Contract Operations partners and stakeholders in various meetings, initiatives and projects. The audit responsibilities of this position are critical to ensuring the integrity, accuracy and compliance of Contract Operations processes and activities and external contracted customer compliance. Senior Audit & Analytics Managers are expected to play a leadership role in guiding overall compliance operations and practices across Contract Operations. As such, Senior Audit & Analytics Managers may have one or more direct reports and they also share some of the other departmental management activities with their manager, e.g., reviewing the work of others, representing Contract Operations compliance to cross-functional teams, partners and stakeholders, preparing and delivering senior management presentations on strategic or complex issues, and leading strategic projects.

• Acts as a lead SME for Contract Operations and customer audit compliance and SOPs
• Proactively seeks out complex information on changes in laws, regulations and other external factors and dynamics. Works with manager and other internal partners/stakeholders to interpret the information and assess its effect on current Contract Operations systems, processes and practices. Develops appropriate responses, including recommending changes to general and/or auditing and analytics practices to assure Contract Operations’ ongoing compliance and accuracy
• Plays a lead role in development, implementation and ongoing maintenance of Contract Operations SOPs
• Develops, recommends, implements and educates others on performance metrics for Contract Operations general and audit-specific practices
• Oversees and ensures timely and targeted development and delivery of Contract Operations Compliance & Analytics training; including conducting training for other staff members and, as appropriate, others outside of the department
• Leads other project initiatives
• Serves as the primary point-of-contact for SPCM Contract Operations’ compliance and auditing. Includes all compliance-related initiatives and representing Contract Operations’ and customer compliance and audit activities to internal and external partners and stakeholders
• Serves as an expert on all applicable laws, regulations, corporate and business unit standards and requirements and helps drive cross-functional operations to assure compliance, accuracy and achievement of all other key performance metrics for Contract Operations
• Works with other audit managers and internal process SMEs to ensure proper process controls are in place
• Oversees or otherwise supports internal and external audits by organizing, compiling and storing necessary data and creating reports and presentation materials
• Oversees and conducts timely and targeted internal auditing and validation to ensure compliance, as per Contract Operations SOPs and other business, legal and regulatory requirements
• Partners with 340B field account management teams to provide auditing, analysis, reporting and communication support for 340B Program Integrity
• Provides expert post-auditing guidance and advice to cross-functional partners and stakeholders and, where applicable, plays a lead role working with SMEs to identify root cause and develop process-driven solutions and corrective action plans
• Where applicable, closely monitors corrective action plan implementation to assure timely, thorough and compliant follow-through
• Oversees or otherwise performs analyses and provides reporting to identify trends and interpret data related to Contract Operations and customer compliance and auditing activities 
• Plays the lead role in presenting audit and corresponding analytical findings, insights and recommendations to stake...

Associate Group Manager, Government Calculations

The Associate Group Manager, Government Calculations leads and oversees the function and specialist team of calculations managers who process all Government Pricing & Reporting (GP)-related calculations and are accountable for compliance with strict accuracy targets, timelines, laws, regulations, government contracts and GP’s methodology. In addition, the Associate Group Manager is responsible for effective deployment of and improvements to GP Standard Operating Procedures (SOPs), systems, technologies, and data. The Associate Group Manager regularly engages with relevant partners and stakeholders to resolve operational issues. He/she may also lead cross-functional projects from a GP calculations, systems, process or data perspective.

• Acts as the subject matter expert for content and interpretation of various, often complex, government programs, contract strategies, contract issues or terms, e.g. pricing and payment calculations, contract performance, compliance, etc.
• Proactively reviews and assesses existing government programs, contracts, contract administration practices, policies, guidelines, systems, performance tools, etc. versus new, extended or enhanced opportunities. Plays a leadership role in recommending new opportunities; including leading in the development and implementation of such
• In conjunction with Managed Care Contracts Manager, collaborates with the renewal of Federal Supply Schedule Contract
•  Plays a leadership role in GP-wide annual and longer-range strategic and tactical planning
• Leads Government Calculations input into GP annual and longer-range strategic and tactical plans. Includes developing and recommending budget requirements for the work of Government Calculations
• Coordinates with Government Analytics & Compliance on stakeholder meetings and planning initiatives. Provides expert recommendations and perspective to ensure, from the government contracting process and calculations perspectives, effective and efficient policies and contracting strategies
• Develops and cultivates professional relationships internally and externally; including external vendor partners supporting or otherwise involved in work relevant to Government Calculations
• Works with Legal, Government Analytics & Compliance and other groups to evaluate legal and regulatory requirements with government payer pricing and contracting strategies to ensure full and exacting alignment and compliance for Genentech; including all relevant government contracting and calculations processes, monitoring and reporting practices, systems, data and other tools
•  Supports as needed, or otherwise participates in the development of new, enhanced or extended government pricing and contracting strategies
• May present pricing certification decks to senior executives
• Leads development, education, communication, implementation and ongoing maintenance of Government Calculations SOPs, systems, data, reporting templates, and the like. Accountable for development and maintenance of effective GP systems and data
• Plays leadership role in development of performance metrics for monitoring, evaluation and reporting of government payer contracts and programs
• Collaborates with Government Analytics & Compliance to create GP-wide training
• Manages development and implementation of Government Calculations-specific training and ensures team members are provided such training in a timely and thorough manner
•  Leads GP project initiatives specific to GP operations
•  Leads department and team to ensure the highest levels of performance for government contracting processes and price calculations, to include maximum efficiencies and compliance:
•  Manages team to ensure accurate and timely completion of pricing calculations  according to the varying legislation, regulations and terms of contracts for government payers and programs
•  Responsible to ensure ongoing and consistent adherence to all applicable laws, regulations, corporate and business unit standards and requirements 
•  Reviews and approves pricing calculations from team members. Ensures pricing calculations are provided to other Government Pricing & Reporting partners to ensure timely and accurate processing
•  Regularly monitors compliance to internal and external policies
•  Manages any issue resolution 
•  Responds to questions from team members and other partners/stakeholders regarding complex issues that may require interpretation
•  Ensures team prepares and delivers routine and ad hoc reporting, as per departmental guidelines, standardized work practices, or otherwise as needed
• Self and team participate in internal and external auditing; including...

• Acts as a subject matter expert and specialist point-of-contact for internal staff and management and external vendors involved in the distribution and/or administration of Genentech promotional goods:

• Receives and reviews all incoming requests/inquiries
• Reviews incoming promotional goods requests or other inquires in accordance with governing rules, regulations or other policies and procedures to ensure consistent and full compliance
• Provides timely responses and other information to internal and external customers, partners and other stakeholders
• Enters all requests and other information into appropriate departmental or other systems or databases
• Responsible to ensure that departmental systems and/or databases contain current and fully accurate information
• Performs routine and ad hoc analyses and reporting

• In partnership with Vendor Manger, visits promotional goods vendors and
• performs compliance and other operational audits
• Performs routine and ad hoc audits on promotional goods distribution managed by Genentech field staff and management
• Produces audit reports. Reviews with manager and others. Distributes to various parties.  Identifies and communicates potential or existing issues and recommends steps and activities to mitigate risks of non-compliance or other potential concerns
• As and when appropriate, participates in various meetings or conference calls to determine promotional goods needs, requirements, and/or communicate new or updated regulations, policies, procedures or other changes
• Supports manager and other team members, as and when/how needed, to cover for any staff shortages within the department
• Works with manager and other team members to continuously review department processes, procedures, tools and other resources to ensure best practices, optimal efficiencies and effectiveness
• Supports his/her manager and other team members in ongoing training, mentoring and coaching of less experienced analysts
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

Sales Compensation Administration - Analyst / Manager

The Sales Comp Administration - Analyst / Manager role is to support the Sales Operations Incentive Compensation team for all business units / sales forces in administering Sales Incentive Compensation Programs which includes ad hoc analysis and reporting. As such the Sales Comp Administration - Analyst / Manager will be responsible for all sales compensation administration aspects including the maintenance of all sales force reference data, variable pay information, and compensation plan information within the compensation systems (TrueComp) and Incentive Compensation platforms. Additionally they will work with the Business Unit Comp Managers to collect plan design information and be responsible for the oversight of development and testing of compensation plans and rules in TrueComp. He/She will support and maintain the monthly sales and goal validation process, which requires critical thinking and problem solving skills. Candidate will also manage department SOPs, prepare department activity timelines, maintain documentation for various purposes such as program policies, eligibility, auditing & OCM purposes. Candidate will also support multiple supplemental incentive programs including the management of processing guidelines to ensure accuracy and consistency including application design & management. He/She will also help manage awards program documentation, criteria, history, inventory, etc. He/She will maintain content on IC Portals and facilitate process/data management with vendors. Candidate must have SQL skills for querying data and a basic understanding of sales compensation philosophy. Candidate will proactively coordinate with internal partners to ensure data accuracy, optimize operational processes and meet aggressive timelines. Provide adhoc support and analysis, including running queries and producing reports (using Access, Brio, Toad or other sql tool). Strong technical, stakeholder manager and communication skills are required.

Key Responsibilities:

- Primarily responsible for the administration and management of all sales incentive compensation administration deliverables including oversight of system configuration for IC plans, reference data (e.g. eligibility), timely and accurate payout processing, supplemental incentive programs, reporting and reference data management for all brands.

- Partner with Sales Operations Managers, Vendors and/or the Information Technology team to define data and reporting needs in support of the IC payout process and supplemental incentive programs.

- Collaborate with various internal and external stakeholders to ensure fairness and consistency in the implementation of and adherence to program policies.

- Communicate with field sales management in support of the sales incentive program payout process and provide supplemental incentive programs summaries.

- Development communication and reporting materials to support IC administration activities and status reports.

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

This position may be filled at a Product Manager or Sr. Product Manager 

Senior Product Managers in Managed Care Marketing develop, implement and manage the managed care marketing strategy, plan and tactics for the assigned managed care segments in the U.S. and related territories. 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 in the assigned managed care segments and may also have matrix responsibilities to represent Managed Care Marketing for one or more products or franchises, as assigned.
 

• Plays a key role in development and delivery of the Genentech & Product Value Proposition
• 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 for assigned segments
• 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
• Responsible for expertly creating and managing 3-year and 1-year managed care marketing strategies, plans, and tactics for assigned managed care segments
• 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
• Collects customer insights through advisory boards, strategic councils and focus groups, develops key portfolio resources for MCCO (Managed Care & Customer Operations) field such as disease state/product marketing materials, B2B strategic talking points, eMarketing planning and execution, and training the MCCO field in all such tools
• 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

Job Purpose:

The Team Lead for CSV auditors in PDQA is responsible for recruitment, management and leadership of department audit staff.  Through their leadership and direction, they ensure consistent implementation of PDQA processes and procedures and execution of the audit strategy related to Computer System Validation

Primary Responsibilities and Accountabilities:

• Provide leadership and direction to the PDQA CSV audit team in the execution of the department strategy
• Recruit, manage, train and develop staff
• Motivates and manages team members through setting of individual goals, provides on-going feedback and performance evaluations
• Oversee staff expenditures
• Collaborate with other Team Leaders to resource and manage the audit program in line with PDQA Strategy 
• Manage resources according to department strategy
• Review staff deliverables (audit plans, audit reports, quality plans, etc)
• May participate on audits as necessary (staff evaluations)

• 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

• Supports Head of CSV Strategy and TL, Validation Analysts to establish and implement global CSV strategy, goals and objectives for team
• Participates on IT/CSV projects and task forces to provide quality management oversight

• Ensure consistent execution of PDQA strategy, processes and procedures
• Oversee execution of department strategy, processes and procedures
• Provide CSV compliance advice to staff 
• Ensure audits are conducted and reported in compliance with departments procedures
• Support regulatory authority inspections
• Escalate compliance issues/risks to PDQA Management
• Maintain knowledge of HR Corporate policies and procedures
• Maintain knowledge of current regulatory, GCP, GLP, CSV and/or PV regulations and guidelines and company policies, SOPs and procedure

There is an opportunity in the Technical Regulatory organization at Genentech at the Product Manager level.  This position requires use of regulatory and technical knowledge to develop, execute and oversee regulatory initiatives and strategies.  This individual will work with cross-functional project teams to develop regulatory strategy and ensure the success of regulatory filings through submission of high quality documents supporting the company’s development product portfolio.  Responsibilities will include accountability for IND, IMPD, and BLA/NDA/MAA applications as well as informational and pre-submission meetings with global health authorities, partners, and industry experts.  Additional responsibilities include leading departmental business process initiatives, and proactive communication with Regulatory and cross-function personnel and partners.  Candidates with a combination of broad technical, process and product development, and CMC regulatory experience are desired.

Position Purpose

The Inspection Specialist supports the Roche/Genentech Pharma and gRED/pRED organizations by coordinating, managing, and preparing for Good Clinical Practice (GCP), Pharmacovigilance (PV), and Investigator Site inspections conducted by global health authorities.

Major Responsibilities and Accountabilities

• Coordinates scheduling and logistics for inspection related activities.
• Collaborates with other Pharma / gRED / pRED functional areas for activities related to inspection preparation.  Activities include, but are not limited to, preparation of relevant materials and conducting inspection related training.
• Participates in pre-inspection visits of investigator sites ( approximately 20% travel).
• Participates in health authority inspections and helps ensure that roles and responsibilities have been defined and assigned for each inspection.  Assumes a role as required by the scope and nature of the inspection.
• Provides guidance to inspected parties regarding the completion of inspection corrective and preventative action plans (CAPAs).
• Assists in the preparation, conduct and management of mock inspections conducted of Roche/Genentech functional areas.
• Assists in developing and maintaining policies, standard operating procedures (SOPs), and guidelines for preparation and conduct of inspections within Roche/Genentech Pharma.
• Assists in preparing periodic summary reports and trend reports related to Roche/Genentech inspections.
• Develops and maintains expertise in international GCP regulatory requirements, international PV regulatory requirements, and policies, SOPs and project-specific procedures within Pharma applicable to the clinical trial methodology and Pharmacovigilance processes.
• Monitors trends in health authority inspection activities to proactively identify potential areas of risk for Roche/Genentech.
• Responsible for the coordination of Inspection Readiness (IR) modules and if required provides a country-specific / function-specific summary report.
• Provides support to the IR Program Manager.
• Provides support to and communicates with Inspection Readiness Key Contact (IRKC) personnel globally.
• Assists in identifying needs for updates to training materials, IR modules and all documents required for the IR program.

• Is a standing member of the site and/or regional Regulatory Technology Leadership Team
• May lead the site or regional Regulatory Technology management team. Drives best practices and operational excellence within the department and cross-functionally and ensures timely communication and information dissemination across the department and beyond
• As needed, ensures appropriate appointment of staff members as ad hoc members in Regulatory Affairs Functional Teams (RAFT); driving and ensuring effective and efficient support for cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution
• As assigned, self and staff may act as standing or ad hoc members of other teams for special or ongoing initiatives and projects

• Develops and manages annual and/or longer-range departmental budgets and resource plans
• Tracks departmental expense budgets to ensure compliance with agreed parameters
• Where applicable, self and team may participate in the negotiation with and commissioning of external vendor partners to support the work of Regulatory Technology
• Accountable for appropriate resourcing decisions for assigned Regulatory Technology function and staff
• Cascades strategic and other relevant goals and objectives as well as budget and other resources to direct reports
• Leads recruitment, hiring and on-boarding for his/her staff member positions. May include, as needed, short-term contract personnel
• Plays a lead role in creating and maintaining a positive work environment by encouraging mutual respect, innovation and accountability at all levels (global, site, functional, projects/programs)
• Ensures that performance of assigned Regulatory Technology management and staff is proactively managed and that management and staff are appropriately trained, developed and coached to maximize their contribution and ensure compliance with Roche and regulatory guidelines and standards. Accountable to ensure assigned management and staff consistently complete their deliverables and other responsibilities on-time, on-target and within-budget
• Conducts ongoing performance management and completes the required steps of Roche’s performance management process and cycle. Includes individual development plans/career discussions and actively contributing to performance calibration, talent management and succession planning processes
• Actively participates in management and skill development programs for continued professional development
• Leads routine and ad hoc meetings with assigned Regulatory Technology management and staff
• Identifies, recommends, assigns or otherwise undertakes special projects that further the success and effectiveness of Regulatory Technology and/or PDR overall
• As needed or otherwise appropriate, acts as a substitute for his/her manager in various meetings, communications or other forums
• Consistently complies...