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.  This role is focused on customer-specific pull-through through use of marketing tools and resources, including application of Value-based Healthcare, promotional, B2B, brand and other relevant resources for key accounts

• Acts as a key liaison to cross-segment MCCO (Managed Care & Customer Operations) account management teams and as MCCO liaison to relevant brand teams
• Consults and prioritizes with MCCO field leadership on most important accounts
• 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
• Works with various MCCO account management teams to develop and communicate the managed care marketing strategy for assigned managed care customer segments
• Provides strategic consultation to account management-led account planning
• Identifies and recommends account-tailored marketing opportunities
• Effectively and efficiently applies VBH, promotional, B2B, brand and other relevant resources to accounts, as appropriate 
• 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 wi...

MSL-Oncology

The states covered are Arizona, New Mexico, San Diego, Orange County, and Southern Nevada

Main Purpose of the Position:
The Genentech, Inc., Medical Science Liaison (MSL) functions as a field based member of the Medical Affairs organization. MSLs are scientifically trained professionals with strong clinical and / or scientific backgrounds. MSLs are expected to facilitate and implement the clinical strategies of Medical Affairs through:
* Relationship development
* Clinical trial support
* Scientific/clinical education and communication

Job Duties/Responsibilities:

General:
*Adhere to corporate compliance in all activities, including those related to clinical trials, scientific presentations, and responses to unsolicited requests for information.
*Maintain clinical, scientific, and technical expertise in specific therapeutic areas; review scientific journals, attend scientific and key technical meetings.
*Represent the Medical Affairs organization to investigator community
*Maintain ongoing long-term collaborative relationships with investigator and thought leader communities

Clinical trial support: MSLs interact with Genentech Medical Directors and their designees to determine and coordinate health care practitioner, researcher, and investigator activities.. MSLs act as the conduit between external customers and the Genentech Medical Directors.

Customer/Investigator support:
*Respond to and document unsolicited requests for information on our marketed products and products in clinical development
*Represent Genentech products at medical information exhibits during scientific symposia.
*Facilitate investigator and thought leader interactions with GNE Medical Directors

Commercial support:
*Provide internal clinical input and training to Commercial functions within regulatory guidelines
*Provide clinical and scientific support for Advisory Boards
*Content development/scientific review of content and presentation materials, upon request

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

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

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

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

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

Provides clinical oversight for a variety of projects, in consultation with his/her Medical Director or Senior Medical Director :

·         Works with a host of internal and external partners and stakeholders in the implementation of clinical trials for assigned drugs/indication

·         Provides scientific input into and/or coordinates the development of specific clinical trial documents for review and discussion with Medical Directors* (e.g., protocols, charters, safety monitoring plans, process documents, etc.) including disease and/or treatment registries

·         Participates in the identification of appropriate external investigators

·         Oversees the clinical trial implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators and Clinical Operations. Active Member in Study Management Team for assigned drugs/indications

·         Develops and cultivates relationships with external partners such as clinical investigators, clinicians, scientists and KOLs, as well as cross-functional partners in Clinical Development, Commercial, Legal and Regulatory.

·         Supports his/her manager in developing clinical components of presentations* for clinical trial investigator meetings

·         In collaboration with his/her manager, coordinates the preparation and reviews data outputs for reporting documents* where appropriate (e.g. clinical study reports, analysis plans, etc.) with the CRO, the Medical Affairs Biostatisticians and his/her Medical Directors

·         Monitors project progress and is expected to proactively identify any issues or challenges and recommend and implement strategies to effectively resolve such once approved with his/her manager

·         Works closely with his/her manager, the publication team and Clinical Operations to complete associated publications, reviews draft publications*.

·         Keeps all partners abreast of projects progress throughout all applicable intervals

·         May also participate/coordinate collaborations with external stakeholders

(e.g. cooperative groups, other companies, etc.) on development and implementation of

approved clinical projects.

·         May coordinate, liaise with internal and external providers for data mining activities

·         Helps his/her manager provide data outputs requested for safety and/or other relevant sections of IND annual reports, if these sections and reports relate to assigned drugs and/or indications*.

·         May interact with NCI or other agency, as appropriate, with supervision from his/her manager

¿ Stays abreast of internal and external developments (scientific, clinical, commercial, competitive, legal, regulatory and like) as such developments may implicate or otherwise impact the implementation of the medical plan of the assigned drug(s)/indication(s). Includes attendance at major scientific conferences, participation in competitive intelligence activities, and review of published literature

3 positions available for locations in SSF. Washington DC or Basel

Main Purpose of the Position:

·        Provides objective and uniform assessments of quality and compliance risks across global network, including independent expert review of (1) the internal GMP auditing program and (2) correspondence to global health authorities regarding GMP issues.

·        Supports support liaisons and interactions with external bodies and committees to influence on technical quality issues through articles, speeches and participation on committees

Job Duties/Responsibilities:

·        Performs independent expert assessment to determine global uniformity and conformance to appropriate regulatory standards for (1) internal GMP audits and (2) correspondence to global health authorities regarding GMP issues, including written responses to inspectional observations.

·        Advise senior management across PT Global network on best practices, regulatory intelligence, key opportunities, and possible threats in the areas of quality and compliance. 

·        Provides up to date regulatory and compliance information and trends, specializing in specific regulatory authorities and regions, providing timely information to the PTQ organization.

·        Contributes to expert GMP compliance opinions for PT Global network, including Manufacturing, Quality, and Regulatory Affairs.

·        Participates as a key member of teams throughout the global Technical Operations Quality organization for strategy and policy, external interactions and influencing activities as they relate to Quality and GMP/GDP Compliance

·        Supports the overall efforts for strong health authority relationships in the areas of Quality and Compliance through effective communications, interactions and participation in meetings, conferences and committees with focus on respective region or area of expertise.

Crystallography Post Doctoral Fellow - Hymowitz Lab

Responsibilities:

A position is available for a postdoctoral fellow with expertise in crystallography to join the Department of Structural Biology at Genentech, Inc.  Active areas of research include the structure and function of intracellular signaling cascades involving ubiquitin as well as the structure and function of protein complexes relevant to human disease. The successful candidate will be involved in all aspects of crystallography, including expression and purification of proteins, crystallization, data collection, structure determination and analysis of protein structures.

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.

• 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.

Level: E4/E5
The position is for a recognized expert and leader as it relates to process and cleaning validation and operations with the ability to gain alignment, advise, coach and train.  This includes expertise in the principles and approaches of process and cleaning validation, and is responsible for leading the continued development, implementation and execution of the process and cleaning programs meeting health authority requirements.  The Principal Technical Manager will develop solutions to complex Quality system and governance issues and initiatives with inter-organizational impact following cGMP regulations and Roche standards.
• Recognized expert and leader as it relates to process and cleaning validation and must have the ability to gain alignment, advise, coach and train Validation and Operations personnel with respect to process and cleaning validation requirements.
• Expertise in the principles and approaches of process and cleaning validation, leading the continued development, implementation and execution of the process and cleaning programs meeting health authority requirements. 
• Develop solutions to complex Quality system and governance issues and initiatives with inter-organizational impact following cGMP regulations and Roche standards.
• Identify and implement solutions to complex Quality system governance concerns and improvement opportunities with multi-site and inter-organizational impact. 

Key Accountabilities:
• Provide Process and Cleaning Validation and Operations expertise to develop, implement, and sustain PQS requirements in accordance with worldwide GMP regulations and Roche standards.
• Act as Global Coordinator for the development, deployment and implementation of the  PQS Product and Process Lifecycle and associated global standards and processes.
• Adhere to Roche’s Quality philosophy and utilize PQS business process and applicable Quality systems, i.e., CAPA and Technical Change Management tools.
• Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address a broad range of complex problems.
• Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
Who You Are:
• Collaborative Leadership – Looks for opportunities to help others.  Works well in a collaborative team environment and communicate effectively with customers, peers, and senior management.  Demonstrates respect and appreciation for a diversity of perspectives.  Maintains professionalism in presence of conflict.
• Technical Leadership – Demonstrates ability to provide technical leadership and teamwork in a GxP environment across functional and organizational boundaries.
• Ownership and Accountability – Takes accountability for actions, drives results, and learns from mistakes.  Holds oneself accountable to fulfill assigned tasks and achieve results within timelines.  Initiates additional assignments and assumes responsibilities as appropriate.  Determines methods and procedures on new assignments.
• Communication – Is thorough in capturing all relevant information in communications. Conveys concepts and positions clearly, with straightforward language, both verbally and in writing.  Readily grasps the main points in communication from others.  Asks questions for clarification.
• Planning/Organization – Responds to new requests with appropriate urgency and with an organized approach.
• Problem Solving – Identifies problems, defines problem statement clearly and accurately, and applies structured and disciplined methodology to identify root causes.  Is effective in solution development, risk mitigation, stakeholder buy-in, and execution.
• Customer Focused – Partners with customers and looks ahead to predict future customer needs.  Manages expectations.
• Technology Platform Experience – Has exposure to and expertise in multiple GxP environments.  Executes work in collaboration with multiple technical disciplines.

Summary of Position:

The non-interventionalprogram (NIP) Coordinator is the specific point of contact for requestsregarding NIPs.  The NIP Coordinatorensures that all NIPs conducted by Genentech are approved, tracked, andconducted in accordance with relevant regulations and company internalprocesses and procedures.

Job Duties/Responsibilities:

• Liaison with the BusinessUnits to ensure a proactive review and assessment of all proposed NIPs.
• Provide support to scopestaff handling NIPs by answering questions or providing advice on good NIPpractices as defined in laws & regulations, codes and internal guidelines& SOPs
• Ensure timely involvementof line management in case of violation of good NIP practices
• Create and maintaintraining for good NIP practices, regulations, codes and internal guidelines& SOPs
• Ensure scope staffawareness of ongoing changes to regulatory or local requirements, and new proceduresand policies on NIPs. Co-ordinate in-house and external provider training byliaising with other departments, external trainers, or running courses,including functional orientation/induction program for new employees
• Identify the need forcreating additional or updating existing SOPs or processes/working guidelineson good NIP practices
• Responsible for tracking of NIPs under their scope of responsibilityinto NIP database(s)
• Ensure each NIP has a program outline which details the nature of the program and safety data collection and reporting processes
• Proactively reportsconcerns/issues to the NIP Coordinator Lead toensure compliance with safety SAE and non-serious AE reporting requirements are met
• Ensure a quality control and reconciliation process is in place for on-goingNIPs and conduct a NIP risk assessment at least once a year as per globalSOP(s)
• Liaise with other NIPcoordinators and be a proactive member of the global NIP network (identify newNIP requirements, develop preventive and corrective measures against NIP risks,maintain and promote good NIP practices across GPS and affiliates)

Purpose:

This Principle Technical Manager will manage the Quality oversight related to sterile diluents manufactured at a Contract Manufacturing Organization (CMO) located in North Carolina.  This person will be a key member of the CMO governance team to support right to operate and supply of diluents packaged with several critical Genentech/Roche products.

Responsibilities:

·         Influence and drive Right to Operate and continuous improvement to achieve compliant and reliable supply of diluent for Roche products.

·         Establish and monitor CMO Quality goals and metrics to drive continuous improvements

·         Recommend, implement, and drive strategic objectives and goals of the CMO relationship

·         Facilitate issue resolution and problem solving within CMO site, with Roche/Genentech functional departments supporting Contract Manufacturing, and through the agreed project governance structure as appropriate.

·         Manage the release of product, including batch record review, investigations, change controls

·         Partner with the CMO to ensure proper aseptic control during Roche operations

·         Observe end-to end production activities that include filling, terminal sterilization, visual inspection, and labeling

·         Work with CMO to align requirements for visual inspection of diluent

·         Make decisions if issues arise during production

·         Support validation activities, product complaint investigations, creation of Annual Product Reviews, and other quality functions as required

·         Develop/maintain quality risk management plans and risk logs; utilize risk management tools to identify and mitigate CMO quality and compliance risks 

·         Ensure that CMO meets Roche Pharmaceutical Quality Standards (PQS)

·         Participate in regulatory inspections and GNE compliance audits

·         Develop and negotiate Quality Agreement with CMO

·         Support any regulatory filings for diluent manufactured at CMO

·         Present quality topics to varying governance bodies, such as Quality Review Boards, Operational Review Meetings, and Roche/CMO Steering Committees

·         Serve as the Quality representative on cross-functional and multi-site teams

Senior Manager, Internal Communications, Corporate Relations

The Position

The Senior Manager, Internal Communications, reports to the Director of Internal Communications within the Corporate Relations function. This position is responsible for providing internal organizational communications consultation and support to (1) Genentech’s Chief Financial Officer and (2) the Senior Vice President, Secretary and Chief Compliance Officer, Genentech and head of Legal Affairs, North America. In addition, this position is responsible for consulting on communications initiatives from these and other G&A functions to our approximately 12,000 employees, and will play a key role in developing business communications for leaders and for key best companies submissions. This individual will interact with the company’s senior executives as well as with peers in Internal Communications, Corporate Relations and internal communicators throughout Genentech and Roche.

Responsibilities

• Prepare and maintain strategic, annual organizational communications plan for the Finance and Legal groups
• Provide communications channel analysis and usage proposal
• Draft, coordinate written communications & presentations for leaders
• Partner on content and theme development for each department's employee forums (e.g. leadership conferences and town halls)
• Advise on layout and develop content for department intranet sites.
• Partner with Finance and Legal leadership teams and HR on major announcements affecting organization/organizational change
• Consult on and/or prepare and execute communications plans for G&A initiatives that influence how our approximately 12,000 employee experience working at Genentech (e.g., IT, Procurement, Site Services, EHS, Security, etc.)
• Prepare written communications for senior leadership (C-suite).
• Write original content for several best companies submissions.

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

Finance Manager, FP&A

Reporting to the Associate Director, FP&A, the Finance Manager will support the corporate planning processes, including forecast, budget, and long-term planning.  This position will be responsible for both delivering forecasts/budgets to local management as well as submission of the plans to Basel.  This role will require significant interface with other finance and planning groups across the organization.

Job Description:

• Manage and coordinate planning exercises to meet corporate reporting schedules and goals
• Review and analyze planning data and develop presentations for senior management review
• Act as the primary liaison with Basel (Global HQ) and functional finance teams (at South San Francisco) for all planning-related issues
• Lead ad hoc analyses as assigned to support senior management strategy discussions and decisions
• Proactively identify, design, and implement enhancements to existing planning processes and systems 

The incumbent in this position willbe responsible for managing Device Development Quality areas includingdevelopment of Design Controls and associated documentation, documentationcontrol system implementation, as well as coordinating educational forums for projectteams. Quality System areas of accountability include Risk Management, DesignHistory Files, and other aspects of Design Controls. With respect to DesignControls, responsibilities include participation in cross-functional initiativesto develop, influence and globally align the Design Control strategy whileensuring consistent practices are adopted and followed. The incumbent will alsoserve as the primary liaison / spokesperson between Quality and the DeviceDevelopment Leadership team. He/she will work with Device Teams to create,oversee maintenance and continuously improve Design Control processes forteams, and drive consistency in approach and documentation content across thepipeline portfolio to streamline development. Regular interaction with DeviceTeam Leaders is required. The position requires working with teams to developand implement Risk Management plans and Design History Files ensure theapproach is consistently applied across projects. The incumbent will supportinternal and external audits of the department, and is accountable for ensuringthat the department is in compliance with regulatory requirements forcombination products. The incumbent will regularly interface with thosefunctions contributing to execution of the Device Strategy including but notlimited to Clinical, Development, Manufacturing Collaborations, Quality andRegulatory Affairs.  The incumbent willalso support the continuous improvement of business processes related tocombination product development and commercialization, providing linkagesbetween the Design Controls and device business processes. The incumbent willalso serve as a departmental representative for commenting on global regulatoryauthority draft guidance and proposed rules.

Primary Purpose of Job (Job Summary)

> Lead and execute on Organizational Communication and Change Management activities in support of projects for the GPP projects.

Principal Roles & Responsibilities/ Accountabilities – Major functions of the position

Management Roles & Responsibilities

* Responsible for the assigned tasks on GPP projects globally

Functional Roles & Responsibilities  

* Lead organizational communication and change management related activities across key GPP projects.

* Assess the needs of change management for specific projects and provide recommendations to address the changes and ensure realization of the project scope and objectives

* Align with and utilize Business Process Excellence (BPE) resources and methodology throughout the project life cycle(s). Ensure that objectives and critical success factors are identified, met and measured.  Strive to develop a well-rounded BPE skill set. 

* Identify risks, anticipated points of resistance and potential lack of sponsorship and develop plans to effectively mitigate these 

* Develop actionable change management plans, including risk assessments, stakeholder engagement, communication, and training plans for any assigned projects

* Coordinate with team members, sponsors, Business process managers, local end users/customers, and stakeholders to ensure alignment with project  and GPP vision, goals, and objectives and understand the needs of customers and stakeholders 

* Work with Team members to integrate change management and communication activities into the overall project plan to secure effective and lasting adoption.

* Facilitate meetings, workshops and other events where communication and change management are required. 

* Actively participate and facilitate at all team meetings as a full member of the assigned project team, 

* In partnership with the Business Process Owner (BPO)/Sub Process Owner ensure an effective business review process with all relevant input about prioritization, impacts, cost/benefits, vision and objectives associated with project deliverables and change management/communication.

* Coordinate with Technical teams and business end users across the project lifecycle in all areas associated with communication and change management

* Work individually and in groups with project team members and stakeholders as needed

* Engage and coordinate with training managers and planners. Make sure the Training Materials and information sharing tools consistently reflect updates with regards to change management and communication (e.g. Roche Wiki, Procurement Manual) 

* Build strong collaborative networks with key stakeholders and ensure communication is concise, consistent and compelling

* Ensure alignment of change management approach and stakeholder outreach across related Infrastructure projects, optimizing stakeholder involvement.

* Ensure compliance with global business process guidelines, policies, and governance.  

* Drive for continuous improvement and scalable and sustainable solutions to meet global needs

* Engage as a fully vested member of the GPP team and support all goals and objectives of GPP

Membership in Decision Bodies and Major Internal Working Groups or Alliances

Decision body, working group

Chair

Member

Guest/ affiliated

Global Pharma Procurement Leadership Team

Procurement Services Leadership Team

Procurement Services BPE Leadership Team 

Procurement Services Infrastructure Leadership Team

GPP Communication, Procurement Academy, Change Management Teams

Project Teams/Related Initiative Teams

Working Relationships

Key internal interfaces:

* Site/Function Procurement Heads

* PMs/ Local Systems Managers / Site Champions/BPm

* Business Process Excellence Leaders/Teams

* Finance and Audit

* Informatics Teams (PGSD / PGST / FPSE)

* Business Process Owner / Sub Process Owner 

* End Users/Impacted parties and stakeholders

* Training Resources/Coordinators and Procurement Academy Leaders

* Project sponsors and steering committee members

* 

Key external contacts:

* External resources for training and coaching as required