The position:

The Senior Engineer in the Process and Project Engineering Group in the South San Francisco Production Technology Department will be responsible for Process Engineering (Process Equipment Design) and Project Management of Drug Product projects for the SSF Production Business Unit.   The support areas include commercial and clinical filling lines, inspection and clinical packaging.  The candidate must also provide mentorship and direction to partner MSAT groups on execution of process engineering design and project management.  In addition, the candidate will provide Process Engineering services such as approval of P&ID changes, IQ, Material of Construction forms, Engineering Design Review and Engineering Change Records.  The candidate will be responsible for development of business systems to support efficiency and sustainability.  The candidate will also help provide strategic direction to transformation of the Drug Product manufacturing capabilities.

 

...

  Responsibilities: This position is for a Validation Engineer  reporting to a Manager of Technology Validation in the South San Francisco Production Technology Department.  The candidate will be responsible for Validation scope supporting the South San Francisco manufacturing plants.  This includes drafting and execution of validation protocols, authoring validation and technical reports and development of project plans.  In addition, the candidate will support technical assessments for quality impact and participate on quality investigation teams.  The candidate will also monitor maintenance of the validated state of basic and some complex equipment and processes.  This includes monitoring operations and resolving moderate validation issues.  The candidate will support introduction of clinical products into manufacturing by participating on campaign/product planning teams and delivering the appropriate validation activities consistent with project timelines.  The candidate may lead cross functional teams or projects.  The candidate will be expected to work effectively in teams, to influence others to generate support for assigned activities or projects and to justify goals to department colleagues.  They will also act as a mentor for those with similar or less validation expertise. ...

Position Purpose:

Epidemiologists work under the supervision of a Global Epi TA Head to review, generate and interpret quantitative evidence on disease from observational data sources to strengthen decision-making and minimize risk throughout research and development.

Major Responsibilities and Accountabilities:

• Works independently using effective epidemiologic principles and methods
• Works effectively in project teams
• Responsible for epidemiologic deliverables to project teams

Primary Skills/Features:

• Contributes to the design of safety signal investigations
• Researches and provides background adverse event rates in order to contextualize observed adverse events
• Designs observational studies and writes protocols under supervision
• Serves as an epidemiologist on observational study teams
• Provides guidance for ensuring data quality during study conduct
• Experienced with principles and techniques of data analysis and interpretation
• Contributes to study reports, analysis plans, and publications for observational studies
• Represents epidemiology and works independently and effectively on cross-functional teams
• Management (projects and/or personnel)
• Manages epidemiology projects for teams
• Identifies and manages contracts for vendors and outsourced projects
• May mentor associate epidemiologists, contract epidemiologists, & interns

Communication:

• Develops agendas, leads meetings, and provides periodic updates to project teams and senior managers
• Seeks appropriate communication channels
• Effectively articulates how epidemiology supports project goals
• May interact with the FDA and other agencies
• Selects appropriate consultants for contract work
• Is highly professional & scientifically rigorous
• Builds an understanding of roles and responsibilities of other functional areas
• Educates teams on epidemiologic methods and principles

...

Responsible for implementing and maintaining the validated state of equipment, IQ,OQ,SIP and cleaning validation programs. Expected to be knowledgeable of and work within GMP regulations. Requires protocol generation, execution, data analysis, troubleshooting skills, deviation investigation and protocol
report closure for the site. Responsible for validation contractor oversight, demonstrating leadership skills and modeling Genentech values and core competencies while working closely with Engineering, MSAT, Quality Assurance and Manufacturing. This position requires strong communication and collaboration skills, the ability to work within teams, facilitate meetings and lead teams.

• Manage and track the Validation program and assigned validation projects and ensure target
• timelines are met and/or issues are communicated / escalated effectively and consistently.
• Generate, review, approve and maintain Validation Project Plans and Summary Reports and other validation lifecycle documents.
• Generate, review and approve a variety of Validation protocols (IQs, OQs, IOQs, PQs, SIP, CV) for equipment.
• Manage protocol execution, perform data review and manage deviation resolution.
• Oversight and management of validation contract resources including work prioritization, execution and contractor budget.
• Strong understanding of commercial production environment and requirements.
• Evaluate and audit the current validated status of equipment/systems temperature mapping and cleaning validation program.
• Proven ability to make suggestions for improvements as well as ensure programs are operating in a compliant and validated state.
• Present validation packages as required for audits and/or regulatory inspections.
• Perform role of subject matter expert and assess change control and discrepancy events for to validated systems.
• Review validation lifecycle documents for compliance with CFRs, corporate policies (QP/QS documents), and site procedures (SOP’s).
• Participate in cross-functional team meetings and where required, lead/facilitate meeting.
• All employees with jobs that require access to the Warehouse must be able to pass the
• Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Ensures there will be integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within their functional area.

...

• Provide project management and administrative support for project team working to determine feasibility of Leadership Energy and Environmental Design (LEED) Certification.

• Work with LEED consultant to set clear performance expectations for team members to ensure successful completion of project objectives.

• Communicates and coordinates among all stakeholders within and outside the GNE organization including but not limited to client groups, service providers, suppliers, procurement to collect LEED Certification data.

• Manage data collected to enable reporting required to generate reports for feasibility or certification processes.

• Organize and develop material for presentation to Genentech and members of the U. S. Green Building Council (USGBC) for LEED Certification.

• Demonstrated success in leadership and organizational management in a technical, team orientated environment.

• Demonstrated ability to anticipate, prioritize, and adapt to changing workload situations.

• Excellent interpersonal and communication skills.

...

Lifecycle management of Enterprise Directory systems (Microsoft, SUN, Kerberos, Radiant Logic VD)

Lifecycle management of Federation systems (Ping Federate, Siteminder, Microsoft ADFS)

Work on projects related with these components

Create and manage Single Sign On integrations (Ping, Siteminder, JBoss)

Support other Identity and Access Management teams: Identity Systems, Access management, on/off boarding (worldwide presence)

Participate in security hardening drills, audits, proof of concept

Work on user requests, incidents and problems

 

• 2-7 years of successful technical experience supporting Enterprise Directories, Single Sign-On solutions and Federation Services for internal and hosted/SaaS applications
• Proven technical operational skills, and capability to create and validate well-structured answers and solutions in area of responsibility
• Proven interpersonal skills to interact effectively with Informatics staff in multiple countries and varying cultures
• Good understanding of Identity and Access Management systems, operations and related processes with focus on Active Directory, Federation Services, Kerberos, SUN LDAP and Password Management solutions.
• Provides 2nd level support related to Enterprise Directories, Single Sign-On and Federation Services.
• Documents the corresponding processes and components/solutions
•  

Problem Management

• Follows ITSM processes for 1st level problem management
• Act 
• s a source for establishing and recommending that multiple incidents should be declared as a problem to the relevant service providers. Tracks problems until resolved.
• Ensures accurate and complete problem tickets logged in ITSM tool adhering to Roche ITSM processes
• Ensures the Knowledge Management System (KMS) is updated with workarounds, known errors and solutions

 

Incident Management

• Follows ITSM processes for handling incidents
• Monitors ticket queues for the relevant workgroup action within agreed targets
• Ensures accurate and complete incident and change tickets are logged in ITSM tool and adhere to Roche ITSM processes
• Manages, meets and maintains service levels where appropriate
• Continuously improves own skills and knowledge base of services provided by Roche

...

The Finance Manager will be part of a team that provides financial planning systems and reporting development, enhancement and maintenance expertise for Roche Canada finance groups and Genentech Commercial finance groups.  The position is located in the United States Eastern time zone and will report to the Finance Manager of Commercial Financial Planning Systems who is based in South San Francisco, CA.  The Finance Manager will be expected to travel to Toronto, Ontario and South San Francisco occasionally – six to eight times per year

The working environment is fast-paced with an ever-changing set of priorities.  The role will interact extensively with the following finance organizations:

• Roche Canada Commercial Affiliate finance
• Roche Canada Informatics finance
• Roche Canada Product Development finance
• Genentech Commercial Affiliate finance
• Genentech Affiliate FP&A finance (embedded in Commercial Affiliate finance)
• Other Financial Planning Systems teams, and Pharma and Global Informatics 

MAJOR RESPONSIBLITIES  
• Design, develop, enhance and maintain financial performance management applications (almost exclusively IBM Cognos TM1)
• Design, develop, enhance and maintain web-based reporting solutions (almost exclusively IBM Cognos BI Report Studio and Cognos Office Connection) whose data is sourced from the performance management applications
• Support business planning processes identified below:
o Current year forecast
o Next year budget
o Long range (strategic) business plan
o Accounting month end close
• Process improvement initiatives

MAJOR SKILLS / TRAITS
• Strong communication and presentation skills and demonstrated success in building partnerships across organizational boundaries
• Commitment to customer service with a strong sense of ownership for projects and results is a must
• Strong work ethic, independent, flexible and demonstrated ability to work autonomously
• Independent self-starter and proactive leader; seeks to continually improve business processes
• Solid understanding of finance and accounting flows as well transaction flows in ERP systems
• Proficient understanding with:
o IBM Cognos TM1, a Performance Management OLAP technologies:
o Master data, transactional data, and data flows within information systems
o IBM Cognos Report Studio, a web-based reporting solution
• Ability to multi-task and meet deadlines in a highly demanding and fast paced environment

...

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 

...

POSITION:

Finance Manager (G&A Finance)

Reporting to the Associate Director, G&A Finance, the Finance Manager will provide strategic and traditional finance support to the Workplace Effectiveness, EHS and Security groups within the Site Services organization.  Workplace Effectiveness includes Genentech Real Estate, Workplace Planning, and SSF Site Engineering.  The role will interface with key stakeholders within Site Services, Finance, and other areas within the Genentech/Roche organization.

JOB DESCRIPTION:

Manage and coordinate planning deliverables to meet corporate objectives and deadlines. This includes annual budget, quarterly forecasts, the 5 Year & 10 Year Business Plans 

• 
  
• Manage the month/quarter end close processes including journal entries, accruals, account reconciliations, reporting, detailed variance analysis of results
• Member of the Workplace Effectiveness Forum - provide financial and non-financial support to assist in strategic decision making
• Build and maintain effective and collaborative business partnership between the Finance team and Workplace Effectiveness stakeholders
• Proactively identify, design, and implement enhancements to existing processes
• Propose and implement innovative solutions to complex business issues through ad hoc analyses
• Effectively communicate financial information with all levels of the organization, including senior management

...

The Position

Senior Finance Manager/ Finance Manager commensurate with experience

JOB DESCRIPTION:

Position is dedicated to supporting the financial management of the Oceanside Product Operations, part of the Roche Biologics Operating Unit (OU). The position will report to the Site Finance Head for Oceanside and is part of the Pharma Technical Operations Finance group, which is charged with the financial stewardship of Genentech's Technical Operations organization.  Beyond delivering on core job objectives, the position will have the opportunity to extend and lead other site and global network initiatives.

MAJOR RESPONSIBILITIES:

Responsible for the financial planning, analysis, and reporting activities of the Oceanside Drug Substance Manufacturing operations.  Act as a key Finance business partner to the functional heads of the operations and quality organization.  Develop strong business acumen and partner with the OU to help guide the business functions and support business and financial analysis.

Planning and Analysis

• Lead execution of planning exercises (forecasts, budgets, long-range plans) and coordinate efforts with business partners to prepare operating expense, headcount, and capital forecasts so that all submission requirements and deadlines are met. 
• Analyze budget forecast proposals for strategic consistency and suggest modifications as appropriate. 
• Provide support for all budget reviews and submissions. 
• Identify and execute opportunities to improve operational results. Partner with OU management to achieve targeted costs and continuously improve. 
• Analyze spending and cost of production monthly and provide direction to OU management to balance risk and cost targets.
• Develop financial decision frameworks for operational issues and lead analysis through final recommendation. 
• Work with OU functions to provide input on the development and tracking of appropriate metrics and goals for planning horizon.
• Lead business case analysis for site and network initiatives.

Reporting

• Perform efficient and pertinent month-end reporting, including investigation of spending and manufacturing variances. 
• Prepare and present monthly financial results to site and financial leadership. 
• Use financial reporting to direct OU management toward areas of improvement or to surface operational issues. 
• Prepare and present quarterly capital spending updates to site and Technical Operations leadership. 
• Support Site Capital Governance Team in Capital Reporting, Planning and Financial Analysis. 
• Business Partnership
• Be a strong business partner to Operations function heads, learn and help navigate the business using finance metrics, results and KPIs as tools.
• Support site team governance structure with standing membership of SMART, IMPACT, JMT teams.
• Drive continuous improvement and risk mitigation projects in partnership with functional leaders.
• Financial Management & Controls
• Perform month-end close activities, including monthly production activity, cost allocations and reconciliation of inventory balances. Identify, investigate, and resolve potential issues within tight time constraints. 
• Manage and control expense and capital transactions through the corporate accounting system (SAP BW) including maintaining and reconciling accrual transactions. 
• Communicate effectively with internal finance departments, including Vendor Finance, R&D Finance, Capital Finance, Corporate FP&A and others to ensure quick and accurate resolution to financial issues. 
• Support and direct Internal Control audits.
• Monitor compliance to corporate financial controls and code of ethics.

MAJOR SKILLS AND BEHAVIORS:

• Demonstrated analytical acumen and problem-solving skills. 
• Independent self-starter and proactive leader. Seeks to continually improve business processes and add value. 
• Strong communication and presentation skills and demonstrated success building partnerships across organizational boundaries.
• Commitment to customer service with a strong sense of ownership for projects and results. 
• Must be able to work in a fast-paced environment that often requires commitment of more than 40 hours week.
• Good business acumen and strategic thinking.
• Ability to work collaboratively as a team with business partners.
• Ability to stand in for Site Finance Head and  work with senior leadership team as needed.

...

The Forecasting Manager/Senior Manager will support Brand Teams and
Commercial Management decision-making by delivering revenue forecasts
on a regular basis throughout the year as well as in response to ad-
hoc customer requests. This individual will play an integral role
with responsibility for ensuring that all forecasts are based on
reliable information and rigorous analyses, including uncertainty
analyses, and that short-term and long-term forecasts are aligned.
He/she will partner with different functional groups (Marketing,
Customer Operations, Finance, Supply Chain, and other groups within
Market Analysis & Strategy) to deliver analyses that enable a
thorough understanding of brand performance and expectations. He/she
will work with multiple Excel-based models as well as other
quantitative and qualitative resources to perform scenario analyses.
In addition, he/she is expected to present findings to key
stakeholders, provide recommendations, and implement approved
recommendations.

...

Position Purpose:

To provide high quality management, coaching and functional expertise to individuals so that they maximally contribute, deliver and develop.

 

To contribute to Study Management function to develop as a Centre of Excellence for either insourced or outsourced studies and ensure effective implementation at the Site.

Major Responsibilities and Accountabilities:

 

1.     People Development and Management

 

·       Manage, coach and develop people in order to maximize their capability and contribution to provide high quality deliverables.

·       Create a positive work environment by encouraging mutual respect, innovation and accountability at all levels (local, global, functional, projects/programs).

·       Ensure that employees are appropriately trained, developed and coached to comply with Company and regulatory standards.

·       Ensure that communication is managed consistently in a timely manner with the appropriate context.

·       Support management and staff in a matrix environment.

·       Conduct ongoing performance management dialogue. Complete the required steps of the performance management cycle.

·       Conduct individual development plans/career discussions.

·       Actively contribute to the performance calibration, talent management and succession planning process.

 

2. Functional Expertise and Oversight

·       Maintain an oversight of execution of work and deliverables.

·        Ensure that standards and processes are implemented locally to create consistency, efficiency and high standards of compliance.

·        Work effectively with the relevant local and global management to ensure that sufficient, appropriately qualified resources are identified, made available and allocated.

·        Lead/contribute to regular functional forums (at all levels) to ensure knowledge sharing and consistency.

·        Advocate/drive changes within the organization and lead by example.

·        Ensure adherence to company and departmental policies, procedures, guidelines and training compliance (including time reporting, travel approvals, expense reports, conference attendance, etc.)

·       Escalate issues when needed and encourage resolution at the lowest appropriate level.

·       Contribute to the development of global standards, processes and functional initiatives.

·       Proactively manage key stakeholders.

...

GCP experience required for consideration

 

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.

...

Job Purpose:

The PDQA GCP TA Strategy Lead is responsible for the development and implementation of a GCP risk based strategy to deliver an audit program and quality oversight model for studies/products within a therapeutic area.  This role provides oversight to the PDQA program contacts to ensure consistent application of risk based strategy for each program within a TA, and provide actionable data to Therapeutic Area Senior PD management based on analysis of data (audit/inspection/risk) and identification of trends.  This role is to influence TAs in the area of risk and quality management so they can proactively identify and address issues.

Primary Responsibilities and Accountabilities:

• Design and implement a global GCP risk-based Strategy for audit and risk assessment activities for each program in a TA
• Develops and performs risk assessment strategy on each program in TA 
• Supports Program Contacts in risk assessment for each study in program and helps define PDQA priority studies list 
• Develop and maintain risk assessment tools
• Monitors risk data and recommends risk mitigation strategies to TA
• Oversee completion of TA and protocol specific Quality plans
• Input program specific information into risk assessments of internal processes and service providers
• Provide back-up support to all Program Contacts for a specific TA
• Assess and adjust the audit strategy for CTC audits (internal and compliance audits)
• Functions as an audit report reviewer for outsourced CTC Compliance audits
• Analyze data/metrics from audits, inspections and risk management activities for compliance trends and risks for all programs within a specific TA 
• Develop and deliver summary reports (audit/inspection/risk metrics and trends) to TA Leadership
• Provide compliance advice to the TA/product teams and PDQA staff
• May lead or participate in GCP audits for TA 
• Support inspection readiness and inspection management activities for products within a TA
• Support regulatory authority GCP inspections for products in Therapeutic Area

• Provides leadership and direction to PDQ/PDQA and our customers/stakeholders on GCP related activities/issues 
• Establish strong partnership/relationship with TA Senior PD Management
• Review and provide feedback on study risk mitigation plans/CAPAs 
• Escalate significant compliance issues to PDQA Management
• Support PDQ Partner Services in the implementation and oversight of QMS for PDG 
• Provide responses to GCP questions received from Compliance Help Desk for TA

• 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 highest level of awareness, expertise in international GCP regulations and internal policies and SOPs

...

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.

...

Primary Purpose of Job (Job Summary)

> Build up and maintain best-in-industry global procurement risk management and business continuity management in close collaboration with GPP Head of Compliance, Sustainability & Supplier Diversity, the Roche Group Risk Advisory Team and the GPP Head of Risk Management.

> Develop risk management strategies, programs, processes, tools and systems that are in line with the Procurement Sustainability program in order to increase the resilience of suppliers involved in the supply of Roche’s medicines and diagnostics to patients and deliver value to stakeholders. 

> Manage and mitigate the risks related to Roche’s suppliers and ensure their commitment to sustainability by including sustainability and risk management into supplier relationship management.   

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

Management Roles & Responsibilities

* Lead Global Pharma Procurement Risk Management and related strategic initiatives

* Deputize Head of Sustainability, Risk Management & Compliance in Risk Mgmt related topics

* Lead the development and roll-out of sustainable procurement risk management  processes, tools, systems and programs in GPP in close collaboration with Group Risk Management and with category, regional and site procurement heads

* Lead the global risk management governance in GPP, including compliance with GPP risk management policies, processes and training of GPP staff

* Align with Diagnostics and IT Procurement on risk management strategy and related topics

Functional Roles & Responsibilities  

* Develop GPP risk management processes, tools, metrics and systems in close collaboration with Roche Group Risk Management, category, regional and site procurement as well as other Group functions involved (e.g., Group SHE, Finance, Legal, Quality)

* Influence Roche overall global sustainability & risk management programs and contribute to DJSI submissions

* Facilitate identification, evaluation and mitigation of procurement risks in close collaboration with Group functions, category, regional and site procurement heads and the related business partners

* Develop and keep up to date training content (including e-learnings) on procurement risk management to GPP staff and collaborate with Dia, IT on this

* Facilitate joint risk assessments of Roche procurement & sourcing teams with suppliers

* Design global business continuity management for GPP including crisis management, incident response plans and war room playbooks and facilitate implementation

* Drive compliance with the GPP Risk Management policies & processes, the Roche Group Risk Management Process and risk-related Roche Group Policies & Directives

* Support the business process managers with identification, evaluation and treatment of procurement risks related to products, materials/ services and/or suppliers in close collaboration with the stakeholders

* Ensure timely communication and reporting about procurement risks with key stakeholders, including Dia & IT Procurement, business partners and external stakeholders

* Build strong network with Group Risk Officer & team, category, regional and site procurement heads and other functions involved (e.g., Group SHE, Finance, Legal, Supply Chain, Quality)

Working Relationships

Key internal interfaces:

* GPP Head Sustainability, Risk Mgmt & Compliance

* Category, Regional & Site Procurement Heads

* Roche Group Risk Officer & team

* Head of PT Integrated Risk Management & team

* Diagnostics & IT Procurement

* Group SHE, Finance, Legal

* Supply Chain, Logistics, Quality 

* Risk Managers in procurement and other functions

...

Global Competitive Intelligence Manager/Sr Manager, Infectious Deceases

Based in South San Francisco or Basel

Global Competitive Intelligence Manager/Sr Manager - Key Activities:

¿ As a member of the Global Strategic Analytics Team, the successful candidate will be an important strategic business partner to the global marketing teams; International Business, Lifecycle, Disease Area Strategy teams and Roche Partnering.
¿ Works in close collaboration with the International Business Analyst, generating synergies within Strategic Analytics for GPS and the Roche organization
¿ Responsible for cross-functional collaboration to determine competitive landscape for both development and marketed products
¿ Defines and frames business challenges and decision requirements with key stakeholders based on a clear understanding of client needs and priorities. Works with key internal stakeholders and International Business Analyst (IBA) to develop, update and answer key intelligence topics and questions
¿ Leads the collection of competitor information and competitive intelligence from internal and external sources (both published and unpublished) and undertakes the synthesis, analysis and dissemination of this information to support strategic decision making.
¿ You will be responsible for conducting international Competitor Intelligence projects using a variety of methodologies.
¿ Monitors key competitors and ensures timely dissemination of critical intelligence and associated recommendations to appropriate stakeholders.
¿ Leads the coordination, planning and execution competitive coverage at conferences
¿ Proactively promote best CI practice within Roche
Creates an environment of strong team spirit, excellent communication, high motivation and inspires other team members to achieve goals in line with Roche strategies

...

Regulatory Technology is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Roche’s global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. Regulatory Technology Directors and their staff are assigned their responsibilities by varying PDR systems projects and systems maintenance support, as business needs dictate. Associate Directors typically have direct and indirect reports and oversee and guide Regulatory Technology management and staff in user needs analysis and requirements gathering, PDR systems project definition, development and implementation, and process design/redesign to support best-in-class PDR operations and compliance. Associate Directors may lead the site and/or regional Regulatory Technology management team and are standing members in the site and/or regional Regulatory Technology Leadership Team. Associate Directors may also have additional responsibilities, as assigned, to perform the role of Site Lead for the assigned function or cross-functionally for PDR. Associate Directors, by comparison to Directors, are either new to the director-level position, or assigned smaller and/or less complex business areas to support.

JOB DESCRIPTION- PRIMARY DUTIES AND RESPONSIBILITIES

1. Cross-Functional Teams

• 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

2. Staff Leadership & Development

• 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...