HER2 Brand Trainer

Brand Trainers in Commercial Training & Development use in-depth clinical and sales knowledge of the relevant therapeutic area and associated disease state(s)/indication(s), as well as general field-related experience, specific product and marketplace knowledge, to facilitate sales and clinical education training sessions for assigned employee/management groups. Brand Trainers work within a core learning & development support team, made up of their managers, instructional designers, and other project or administrative staff. These teams work closely with internal and external partners/stakeholders to ensure best fit and alignment of developed/implemented learning programs and other offerings.

Example Duties and Responsibilities:

• Works with others to assess existing learning & development curricula and specific programs and other offerings and compare/contrast with immediate-, medium- and longer-term business needs, strategic goals, other targets and anticipated results
• Works with others to build appropriate and aligned annual or longer-range learning & development plans that will support business partners and other stakeholders in Commercial Operations in achieving their strategic and operating goals, targets and anticipated results. May individually undertake a detailed needs analysis/data gathering process/project for key learning & development content/topics/subject matter; providing detailed partner/stakeholder input that helps shape the direction, specific offerings, as well as content and facilitation methods/structure for ultimate design and facilitation alignment
• Works with others to conduct internal business partner/stakeholder reviews of learning & development plans, programs or other activities; ensuring up-front internal client input into the shaping and ultimate development of aligned learning/development plans, programs, and activities
• Translates annual or other cycle learning & development plans, programs & activities into a scheduled calendar of specific sessions/dates for facilitation. Supports manager, peers, team members and others however necessary to finalize and disseminate such calendars, as well as respond to any internal client or external partner questions, concerns, or other comments
• As and when requested, supports others in the development and implementation of an aligned learning & development communication strategy/plan/activities to ensure internal partners/stakeholders are fully updated and aware of all assigned learning & development programs and other offerings
• Periodically, as and when needed/requested or appropriate, delivers internal presentations to fully communicate department's offerings and support strategies
• Actively pursues continued education and awareness of field, product, disease state(s)/indication(s) and surrounding marketplace changes/developments, and uses where appropriate to incorporate into program and other learning event/activity facilitation, as well as provide such information to manager and team members for continuous departmental review/assessment of existing learning & development offerings
• Works collaboratively with manager, peers and/or other team members to identify, recommend, and where appropriate/approved, implement new, creative, innovative learning & development offerings, techniques or others
• Uses approved learning & development plans, curricula, schedule/calendar, specific programs and activities for assigned responsibilities to proactively learn program/other activity content and prepare for expert facilitation. Channels questions, other needs or challenges - in advance - to the appropriate partners; further ensuring full and exacting preparation for expert delivery of assigned learning/development content
• As approved, conducts regular field visits, working with field staff and management one-on-one or in teams. Provides field consultation, team and/or individual coaching and development; enabling hands-on learning/development support to the assigned employee/management groups
• Continuously assesses and evaluates impact and overall effectiveness of facilitation responsibilities. Does so by consistently reviewing learning program participant evaluations, as well as soliciting additional or other feedback, extracting key themes, patterns and opportunities and channeling such to the appropriate internal partners or stakeholders
• Works with peers/team members to ensure maximum leverage of existing resources, tools, programs, content, etc.
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

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HCV Sr. Clinical Coordinator
Territory: IL, MN, WI, ND, SD, and part of MI and KY. (Preferred location is Chicago; will consider Minneapolis) 

HCV Sr. Clinical Coordinators are responsible for the active promotion of Genentech's HCV product portfolio and focus their attention on key specialty customers and thought leaders. HCV Sr. Clinical Coordinators are expected to deliver on-label messages in support of product indications. HCV Sr. Clinical Coordinators implement programs and tools pertinent to the successful expansion of Genentech's HCV products in the treatment of HCV and other approved indications. The job requires an advanced level of technical and consultative selling skills. HCV Sr. Clinical Coordinators are preferably experienced working in a broad range of customer segments and in accordance with operational polices so as to appropriately influence current and future prescribers of Genentech products. The HCV Sr. Clinical Coordinator function is in a dual capacity through independent efforts and as a team player with the field and headquarters-based staff to ensure sound business strategies and services are being implemented. The HCV Sr. Clinical Coordinator must comply with all sales force promotional guidelines. 
...

HCV Clinical Specialist
Territory: Richmond, VA and Virginia Beach, VA areas


The HCV Clinical Specialist, Pegasys Sales manages and develops long-term relationships with physicians and other customers for the customer accounts in the assigned territory. As such, Clinical Specialists represent the assigned GNE brand(s) and their approved indications; helping external customers such as physicians, nurses, etc. learn about the benefits of the assigned GNE brand(s) in relation to the applicable therapeutic area/disease state.

Reports to: Division Manager, Pegasys Sales

Example Duties and Responsibilities:
• Responsible for meeting or exceeding assigned sales targets
• Develops robust territory business plans
• Develops strong and long-term relationships with customers in all assigned accounts
• Presents the assigned GNE brands in a professional, compliant, ethical and effective manner;
helping external customers understand the benefits and use of GNE brands
• Monitors operating costs and compliance with territory budget
• Complies with all laws, regulations and policies that govern the conduct of GNE activities.

...

Group Strategy Manager 

 
The  purpose of the Group Manager, Strategic Pricing & Contracting role is to oversee and/or develop pricing and contract strategies for the assigned therapeutic areas and/or customer segments that optimize the value of Genentech's portfolio, which includes leading cross-functional strategy development teams, building effective relationships across all franchises relevant to the assigned therapeutic areas and/or customer segments and scenario analysis/modeling for overall financial and legal viability, as well as ongoing pricing and contract performance assessment/analysis.

1. Act as a lead subject matter expert from Strategic Pricing & Contracting
2. Play the lead role in cross-franchise assessment and integration of pricing and contracting strategies, plans and tactics; includes providing a leadership perspective and strategic pricing and contracting inputs into all business plans relevant to the assigned therapeutic areas and/or customer segments
3. Provide a leadership perspective on Genentech pipeline developments, as these relate to pricing and contracting strategies development and strategic options
4. Work effectively with Genentech executives to transfer and leverage learning across brands
5. Act as the lead contact on all internal and external communication regarding pricing and contracting strategies, philosophies and practices for the assigned therapeutic areas and/or customer segments; includes responding to internal/external inquiries regarding Genentech's pricing and contracting philosophies and practices
6. Develop internal/external reports, presentations and training to educate others in Genentech's pricing and contracting philosophies and practices
7. Take a leadership role in training other team members and internal partners/stakeholders in pricing and negotiating theory/application
8. Support manager in longer-range departmental planning; determining resource requirements, headcount, infrastructure, systems, tools and the like
9. Act, and is accountable for others in his/her team acting, in complete & total compliance with all laws, regulations and policies

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Group Product Manager, Erivedge Key Customer Team

The Group Product Manager (GPM) will report to the Erivedge Marketing Director. This position offers the opportunity to lead the brand analytics, access initiatives and key customer relationships for Erivedge, a first-in-class hedgehog pathway inhibitor indicated for the treatment of advanced basal cell carcinoma (aBCC). The role will be accountable for tracking performance indicators, implementation of access-to-care and practice management tactics and thought leader engagement, while leading a team of two marketers. Specific responsibilities include development of quarterly business reviews, thought leader development, advisory activities, peer-to-peer promotions, managed care / access programs and providing appropriate commercial perspective to publication planning and medical teams.

Additional responsibilities of this position include: 

• Collaborate with MCCO to ensure understanding and execution of brand strategies within appropriate payer and field-based tactics
• Lead initiatives with MCCO to optimize patient flow from script to shipment 

• Manage development and implementation of thought leader strategies including major conference activities, internal management tools, and participation/involvement in key promotional activities
• Collaborate with field sales, TLLs, marketing colleagues on thought leader activities
• Collaborate with BioOncology partners for implementation of major meeting activities

• Collaborate with Medical Affairs, Clinical Science, and Advisory Board Services to manager advisor activities
• Lead data integration team toward developing and tracking key performance metrics in collaboration with market planning, marketing science, sales operations and forecasting/business analytics team
• Lead and motivate team of two direct reports and manage all activities and professional development
• Managing brand budgets 
• Maintain strong relationships with colleagues in research, clinical, medical affairs
• Actively participate in Oral Oncolytics and BioOncology initiatives and programs
• Comply with all laws, regulations and policies that govern the conduct of GNE activities

Successful candidate should possess:

- Solid understanding of specialty biotech/pharmaceutical marketing and sales

- Solid experience with proven results in managing and motivating direct reports in a marketing role 

- Strong analytical and communication skills

- Direct experience managing through leader relationships and/or extensive knowledge access dynamics for part D drugs

- Proven ability to develop relationships with sales force and across departments for support of strategies 

- Proven ability to work in a fast-paced, collaborative environment which requires significant cross-functional and cross-brand coordination and teamwork

- Proven ability to work in teams and also work autonomously 

- Experience in working with commercial promotional review committees

- Proven track record of adhering to timelines and budgets

...

Group Market Planning Manager Global Product Strategy

Leads a team of 3 International Business Analysts (IBA) that participates actively in global commercial planning efforts by providing unbiased, objective, in-depth information about current and future markets, product performance, customers, and competitors. Additionally, he or she identifies critical business issues and opportunities for growth, collaborates with Roche/Genentech teams, and works to embed an external market point-of view into the strategic direction of the company. This individual will be both a manager and an individual contributor.
This role is a global role based in South San Francisco and he or she is required to travel nationally and internationally.

Key Accountabilities

• Provide an objective commercial viewpoint based on an in-depth understanding and analysis of commercial information.
• Lead team to proactively assess external marketplace/other related factors to support strategic decision-making
• Define/oversee various Strategic Analytics projects and other work completed by team
• Ensure provision of strategic insights/recommendations; enabling business¿partners/stakeholders to make the best-informed decisions regarding their strategies, plans, etc.
• Develop/manage operating budgets and other resource requirements
• Hire, develop and oversee the work of direct/indirect reports
• Comply with all laws, regulations and policies that govern the conduct of Roche/Genentech ¿activities
• Business travel, by air or car, is required for regular internal and external business meetings¿
Capabilities:
• Effectively manage a team of highly driven professionals. Motivate, develop, and retain top talent.
• Grasps key issues quickly, understands the "big picture" and links market research findings to larger issues.
• Uses rigorous logic and methods to solve difficult problems with effective solutions.
• Can see hidden problems; looks beyond the obvious and doesn't stop at the first answers.
• Uses creativity and ingenuity to develop solutions to complex problems, formulates strategies and approaches which may fall outside historical norms.
• Strong commitment to quality. Consistently and thoroughly reviews work for accuracy before sharing with a wider audience. Delivers final products that are well vetted and reliable.
• Demonstrates persuasive written and verbal communication skills. Is effective in a variety of presentation settings. Is comfortable around higher management.
• Can deal with ambiguity and act without having the total picture, is able to effectively pose questions in order to “tease out” information required for decision-making. Can handle risk and uncertainty
...

A Senior Scientist/Associate Director position is available for a highly motivated and innovative scientist with strong leadership and collaborative skills to join our antibody drug conjugation (ADC) program.  Candidates should have extensive experience in protein and antibody conjugations and be a demonstrated thought leader in the ADC field so that they will be able to make immediate contributions to a vibrant and productive program undergoing expansion at this time. The successful candidate will interface with both chemist and biologist in developing new technologies for the production of ADCs as well as optimizing current strategies. The position allows the successful candidate to play a pivotal role in augmenting Genentech’s strong clinical pipeline of new therapeutic ADC candidates.

 

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Provides the operational expertise and leadership to one or more clinical operations teams to ensure the effective and efficient delivery of all operational aspects of one or more studies through all phases of Clinical Study Management (Plan, Initiate, Conduct, Close), in accordance with the appropriate quality standards including ICH/GCP and applicable regulations.

Main Responsibilities and Accountabilities:

• Provides direction and leadership to one or more clinical operations teams
• Develops operational plans including site monitoring strategies, risk mitigation strategies, trial budgets, site selection, and clinical supplies management.
• Builds effective and efficient high performing operations teams and ensures team members are aware of their accountabilities, responsibilities and deliverables.
• Creates team culture and promotes team spirit.
• Develops and maintains effective working relationships with SMT members, with particular focus on affiliate teams, external CRO (for outsourced teams) and co-development partner study teams.
• In collaboration with functional management, coaches, mentors, supports, and provides study specific direction to Study Management team members.
• Oversees the development and maintenance of study specific manuals created by the GSA.
• Contributes to the development and management of the study timelines, resources, budget, risk and quality plans
• Ensures operational tracking tools are identified, including systems to meet the needs of the operations team and ensures reporting to the GSL.
• Develops and manages clinical study budgets (including HQ budget) and contributes to staffing/resourcing plans.  Communicates variances in the budget and action plan for resolution to the GSL.
• Establishes study milestones and ensures accurate tracking and reporting of study metrics. 
• Provides operational input into the development of protocol feasibility questionnaires. 
• Provides clinical operations expertise to ensure operational feasibility and delivery
• Leads the development and finalization of site feasibility questionnaires.
• Leads the creation of the study level patient recruitment plan and retention strategies based on feasibility data and input from the affiliate teams and consultation with the GSL and OPL.
• Provides operational input and insight into all study related documentation (including protocol and informed consent form) and processes.
• Analyzes the feasibility data across countries with input from the affiliates and makes recommendations to the GSL for the strategic country and site distribution and patient numbers.
• Oversees forecasting of clinical/non-clinical supplies
• Designs drug assumption and supply chain process in partnership with Pharma Technical Drug Supplies, affiliates and GSL.
• Oversees the forecasting and management of non-clinical supplies to ensure sites have supplies to run clinical study.
• Delivers the operational elements of the study plan
• Chairs operations team meeting and organizes the investigator meetings, monitor training, CRO kick-off meetings.
• Ensures that reporting of SUSARs is established and maintained for the duration of the study.
• Proactively manages actual study level recruitment versus planned patient recruitment status and communicates variance to the GSL and implements contingencies in consultation with the GSL.
• Primary contact with affiliates to maintain oversight of performance, issues, and their resolution and identify systematic issues and coordinates any corrective action.
• Ensures the completion and finalization of any corrective and preventative action plans resulting from internal site audits.
• Oversees the maintenance of drug supplies and resolution of issues with input from the Pharma Technical Drug Supplies.
• Coordinates responses to study questions or issues from Health Authorities or IRBs/IECs.
• Provides operational input into the development and tracking of SMT goals.
• Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work
• Performs ongoing vendor management (e.g., CROs, Central Labs, IVRS, Reading Centers), including independent negotiation of scope of work, budgets, performance management, and issue resolution.
• Develops and executes appropriate site and CRO/vendor audit and quality plans.
• Identifies areas of best practice and process improvements
• Participates in Pharma Development Operations initiatives and programs as assigned.
• Maintains oversight and ensures consistency of the operational aspects across studies within a project.
• Ensures study adherence to ICH/GCP and SOPs
  

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Global Regulatory Leader

Accountable for regulatory management of a project(s) and leading a matrix team of regulatory professionals.

Primary Responsibilities and Accountabilities

• Accountable for global regulatory strategy and global regulatory deliverables for a PD project 
• Accountable for leading a matrix team of Regulatory Professionals, and for the RAFT deliverables.  Responsible for motivating and inspiring RAFT members
• Responsible for holding regular RAFT meetings, in accordance with RAFT guidance.
• Responsible for representing the regulatory function on cross-functional project teams (Lifecycle Teams).
• Responsible for representing the regulatory function on project specific matters to governance bodies
• Accountable for global regulatory Health Authority Interactions
• Accountable for managing decision-making, and conflict resolution surrounding regulatory issues within the Project Team and RAFT.  Responsible for ensuring appropriate escalation to functional management when necessary.
• Accountable for leading the RAFT on a PD project to:

• deliver strategic regulatory input to the lifecycle management of a project. 
• deliver specific guidance on regulatory issues such as legislation, guidelines, procedures to internal stakeholders (project team, regulatory function, governance bodies) 
• deliver integrated plans relating to regulatory submissions or specific functional projects 
• deliver regulatory submissions, in accordance with project timelines
• manage successful interactions with regulatory agencies and 
• analyse and landscape the regulatory environment for impact on the project and to brief internal stakeholders, as appropriate
• Responsible for sharing best practices within function to ensure efficiency and consistency across teams.
• Responsible for leading special regulatory projects/global process initiatives, as assigned.
• Responsible for acting as a change agent and role model within PDR by modeling best practices.

...

As a key member on project teams the Global Project Manager II (GPM II), Product Development-Project Excellence (PDP) is expected to actively contribute and challenge the definition and development of project strategy, and then help teams to effectively and efficiently deliver on the strategic objectives agreed with the relevant governance body. The GPM II partners with the team leader to anticipate, identify, manage and communicate project risks. GPMs achieve this by delivering high quality project management support and other high value services:

• Applies project management expertise
• Takes accountability for all project management aspects and works
  effectively and closely with the project leader / team leader (PL/TL)
• Enables generation of innovative, exploratory and/or confirmatory options through project management expertise
• Ensures consistency of project planning from exploratory through to confirmatory development and health authority submission
• Contributes to the functional excellence development of project management
• Provides project management expertise to Due Diligence

The Global Project Manager II is accountable for:

• The development, maintenance, pro-active tracking & management of a high quality, ambitious integrated project plan
• Closely and transparently manage the critical path of the project
• Effectively guides a due diligence team through the formation of a comprehensive drug development plan and budget
• Maintaining, tracking, reporting and understanding variances in the integrated project budget by working in close collaboration with functional contributors and finance
• Guiding and managing the team through the value chain processes ensuring effective and efficient team operation
• Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.
• The integrity and accuracy of project information to meet team, management and portfolio requirements.
• Partnering with the team leader in identifying, managing & communicating key project risks and leading risk management strategies

...

As a key member on project teams the Global Project Manager II (GPM II), Product Development-Project Excellence (PDP) is expected to actively contribute and challenge the definition and development of project strategy, and then help teams to effectively and efficiently deliver on the strategic objectives agreed with the relevant governance body. The GPM II partners with the team leader to anticipate, identify, manage and communicate project risks. GPMs achieve this by delivering high quality project management support and other high value services:

• Applies project management expertise
• Takes accountability for all project management aspects and works
  effectively and closely with the project leader / team leader (PL/TL)
• Enables generation of innovative, exploratory and/or confirmatory options through project management expertise
• Ensures consistency of project planning from exploratory through to confirmatory development and health authority submission
• Contributes to the functional excellence development of project management
• Provides project management expertise to Due Diligence

The Global Project Manager II is accountable for:

• The development, maintenance, pro-active tracking & management of a high quality, ambitious integrated project plan
• Closely and transparently manage the critical path of the project
• Effectively guides a due diligence team through the formation of a comprehensive drug development plan and budget
• Maintaining, tracking, reporting and understanding variances in the integrated project budget by working in close collaboration with functional contributors and finance
• Guiding and managing the team through the value chain processes ensuring effective and efficient team operation
• Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.
• The integrity and accuracy of project information to meet team, management and portfolio requirements.
• Partnering with the team leader in identifying, managing & communicating key project risks and leading risk management strategies

...

As a key member on project teams the Global Project Manager II (GPM II), Product Development-Project Excellence (PDP) is expected to actively contribute and challenge the definition and development of project strategy, and then help teams to effectively and efficiently deliver on the strategic objectives agreed with the relevant governance body. The GPM II partners with the team leader to anticipate, identify, manage and communicate project risks. GPMs achieve this by delivering high quality project management support and other high value services:

• Applies project management expertise
• Takes accountability for all project management aspects and works
  effectively and closely with the project leader / team leader (PL/TL)
• Enables generation of innovative, exploratory and/or confirmatory options through project management expertise
• Ensures consistency of project planning from exploratory through to confirmatory development and health authority submission
• Contributes to the functional excellence development of project management
• Provides project management expertise to Due Diligence

The Global Project Manager II is accountable for:

• The development, maintenance, pro-active tracking & management of a high quality, ambitious integrated project plan
• Closely and transparently manage the critical path of the project
• Effectively guides a due diligence team through the formation of a comprehensive drug development plan and budget
• Maintaining, tracking, reporting and understanding variances in the integrated project budget by working in close collaboration with functional contributors and finance
• Guiding and managing the team through the value chain processes ensuring effective and efficient team operation
• Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.
• The integrity and accuracy of project information to meet team, management and portfolio requirements.
• Partnering with the team leader in identifying, managing & communicating key project risks and leading risk management strategies

...

The intern will work in the global Packaging Development group, supporting the Distribution Technology team by characterizing the mechanical properties of different materials used for packaging in the Roche network. The intern will also be using the information gathered in the laboratory to model those materials in silico, and to identify attributes critical to performance. This will help the Packaging Development group by optimizing the final package design proposed while accelerating development and qualification activities. A final report and presentation are expected at the end of the internship.

The intern will learn how to use multiple test equipment including but not limited to Universal (push and pull) test machines, compression, shock, drop and vibration machines, as well as measurement devices. The intern will also learn how to use software for documenting laboratory results, 3D modeling software and effect modeling software. Finally, the intern will get the opportunity to learn about and support other projects in Packaging Development.

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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...

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

...

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

...

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.

...

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

...

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.

...

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.

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