PTR APAC Regional Hub Associate Director

 

Purpose

 

This position will lead a PTR team regionally located in Singapore responsible for Asia Pacific regional management of life-cycle submissions for all Roche products as well as new product registrations by focusing on local needs of Affiliate Drug Regulatory Affairs (DRA) teams to ensure right first-time submissions to Health Authorities.

 

Responsibilities:

 

* Lead team of professionals responsible for regional/local management of lifecycle submissions in Asia Pacific markets, including: market applications (NDA/BLA), post-approval submissions/variations, renewals and annual reports, for pharmaceutical small molecules and biological products.

* In coordination with global PTR Technical Regulatory Leaders, lead submission strategy for execution of lifecycle submissions in Asia Pacific markets associated to management of CMC changes originating at manufacturing sites or affiliates toward maximizing efficiency, quality and rate of submission approvals by Health Authorities.

* Liaise with Regional Supply Chain management team and Affiliates DRA for strategic planning and influencing change management alignment and early visibility/communication/ planning of changes impacting markets in the region.

* Lead assembly of lifecycle submissions for markets under responsibility to guarantee right first time submissions and coordinate with affiliates for timely and effective submission of changes to the Health Authorities.

* Act as subject matter expert in regulatory requirements for post approval submissions and assure maintenance of regulatory intelligence repository for regional markets under responsibility.

* Ensure that the CMC change management electronic systems are timely updated and maintained in alignment with the regulatory information submitted/approved externally by a Health Authority or internally by the appropriate functional area.

* In coordination with Affiliates DRA, act as direct liaison with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert).

Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility.

* Manage tracking of commitments with a Health Authority as result of license/dossier approval and ensure commitments due dates are met.

* Manage work activities for team members supporting the Asia Pacific region.

* The candidate may be required to travel to other Roche sites on a periodic basis.

 

...

PTR Regional Hub Sr. Regulatory Associate (E3) /

PTR Regional Hub Regulatory Manager (E4)1

 

Department:                       Pharma Technical Regulatory (PTR)

Job Family / Category:      PTR Regional Hubs

 

Purpose

 

This position will be responsible for execution and management of regional life-cycle submissions for all Roche products as well as new product registrations by focusing on local needs of Affiliate Drug Regulatory Affairs (DRA) teams to ensure right first-time submissions to Health Authorities.

 

Responsibilities:

 

* The incumbent will be the primary technical regulatory (CMC) point of contact for the Affiliate DRAs and as such he/she will work closely with them and the regional Supply Chain teams as well as with the PTR product managers and the PTR network.

* In coordination with global PTR Technical Regulatory Leaders (TRL), execute regulatory strategy for lifecycle submissions in Asia Pacific markets associated to management of CMC changes originating at manufacturing sites or affiliates toward maximizing efficiency, quality and rate of submission approvals by Health Authorities.

* Coordinate strategic planning with Regional Supply Chain and Affiliates DRA for change management alignment and early visibility/communication/planning of changes impacting markets in the region.

* Assemble lifecycle submissions for markets under responsibility to guarantee right first time submissions and coordinate/manage with affiliates for timely and effective submission of changes to the Health Authorities.

* Act as subject matter expert in regulatory requirements for post approval submissions and maintain the regulatory intelligence repository for regional markets under responsibility.

* Ensure timely update of the CMC change management electronic systems with the regulatory information submitted/approved externally by a Health Authority or internally by the appropriate functional area.

* Upon request, support Affiliate DRA with interactions with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert).

* Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility.

* Manage tracking of commitments with a Health Authority as result of license/dossier approval and ensure commitments due dates are met.

* The candidate may be required to travel to other Roche sites on a periodic basis.

...

Conduct repetitive, predictive, condition based, reactive maintenance and troubleshooting of cGMP production equipment, clean utilities and plant utility systems. Assist with engineering and evaluation of existing and new equipment and processes. This is a Journeyman level position.

• Conduct general preventative maintenance according to SOPs/work instructions and perform planned and unplanned repairs as necessary.
• Conduct routine inspections and monitoring of equipment and systems and documenting systems operating parameters.
• Make appropriate adjustments or modifications within company and GMP guidelines and notify supervisor of any abnormal parameters.
• Lead and organize specialized maintenance and equipment projects. Includes research of methods and devices, assisting with implementation and documentation of change control.
• Provide general labor services throughout all areas maintained by the Maintenance department.
• Responsible for providing data to derive performance metrics for management that will be gathered on a daily basis for monthly reporting.
• Provide technical expertise and training to junior staff.
• Assist as technical SME with identification, purchase, and organization of spare parts.
• Successfully complete training and demonstrate an ability to perform equipment monitoring and operational checks on manufacturing and utilities equipment.
• Cleaning and organization of designated work areas in Manufacturing and Utilities.
• Complete GMP and other controlled documentation.
• Revise or modify existing SOP documentation as necessary and be expected to write new procedures for new equipment and other duties as assigned by management.
• Interact with Manufacturing, Instrumentation, Metrology and Engineering staff members as well as other internal/external customers.
• All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
• Follows established safety and environmental guidelines and procedures for all work performed.  Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions.  Fosters a positive safety culture in which no one gets hurt.
• General Duties: Master Level PM and Repairs of process equipment and systems such as Fermentors, Centrifuges, Mixers, Autoclaves, Washers, Pumps, Agitators, Mechanical Seals, Control Valves, Steam, Hydraulics, Pneumatics, Electrical Controls, Chilled Water, High Purity Water, Compressed gases etc.

...

Main Purpose of the Position:

• Provide day to day support to Non-Commercial Filling and Finishing Operations.

• Solve routine Manufacturing Quality Assurance and Product Release issues with broader scope and increased complexity following cGMP regulations and Genentech standards.  

• Perform assigned tasks and work to achieve company goals and department objectives.

• Perform routine Manufacturing Quality Assurance tasks to support product manufacturing and release.

Job Duties/Responsibilities:

• Follow company policies and procedures.

• Maintain a state of inspection readiness.

• Provide input to the development of personal performance goals and departmental objectives.

• Collaborate with Management to establish and meet targets and timelines.

• Independently manage competing priorities with limited instruction.

• Serve as a Quality representative on cross-functional and multi-site teams.

• Identify and recommend solutions to potential procedure, process and system gaps.

• Provide assistance to customers in support of departmental functions.

• Participate in the design and implementation of department and cross-functional initiatives.

• Apply basic theory and technical principles to address moderately complex problems.

• Troubleshoot and initiate the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.

• Serve as a technical subject matter expert (SME) in support of department functions.

• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.

• Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.

• Perform any other tasks as requested by Management to support Quality oversight activities.

Technical Duties/Responsibilities:

• Evaluate and close complex, non-investigational discrepancies.

• Initiate discrepancy investigations as required.

• Draft and route discrepancy summaries to Discrepancy Management.  

• Perform Assessor and Evaluation activities defined in the Discrepancy Management System (DMS).  

• Review and close completed evaluations and perform additional activities as warranted in the Discrepancy Management Systems (DMS).

• Review, edit and approve controlled documents.

• Assess and summarize complex process deviations.

• Collaborate with internal and external departments on MQA and Product Release projects and commitments.

• Monitor MQA activities to evaluate trends, and report repetitive anomalies, observations, and discrepancies to Management.

• Represent MQA at cross-functional meetings to develop, review, and approve Commercial Quality documents.  

• Independently manage daily activities in order to meet standard lead times.

...

Level : Associate Director

 

Technical Regulatory is a global function that supports strategic regulatory and submission activities for the Roche and Genentech product portfolio. Support of individual portfolio projects is managed through a Technical Regulatory Team, led by a Technical Regulatory Lead (TRL) who matrixes with other key development and commercial teams to ensure cross-functional alignment of strategy and execution.

 

An Associate Director level position is available for an individual to lead a TRT Program Management function that supports the Biologics Platform portfolio. Reporting to the Global Head of Technical Regulatory – Biologics, this individual will work with the Biologics Platform Leadership Team to establish expectations and competencies for TRTs and Technical Regulatory Leads (TRL) at all stages of development/commercialization. The TRT Program Management function will be responsible for TRL development and TRT training programs with support of project management resources and manage TRL talent development processes. In addition, the Associate Director of TRT Program Management will serve as an advisor to TRLs on matters of TRT project management expectations and logistics including those related to Health Authority and Affiliate interactions and planning, coordination and strategy of global filing and regional execution activities. This individual may also manage a small project management group to assist TRLs in project management and training on relevant PM. tools

 

At the portfolio level, The TRT Program Management function will create and manage processes related to regulatory strategy review and governance including ensuring teams create and maintain a Technical Regulatory Strategy Document and that processes for cross-functional communication of technical regulatory risk are in place. This individual will be the primary contact to leaders in key stakeholder organizations regarding TRT and TRL interactions, roles and responsibilities and deliverables and will coordinate joint meetings between regulatory (BioRAC) and stakeholder advisorial/governance bodies (BQC, LSTDC, etc) when needed. This individual will be responsible to plan and manage an annual portfolio review of technical regulatory programs, and assist the Biologics Platform Leadership team in linking resource planning to strategic Portfolio management. 

...

Department:                       Pharma Technical Regulatory (PTR)

 

Job Family / Category:      PTR Regional Hubs

 

Position:                             PTR Regional Hub Sr. Regulatory Associate

                                           PTR Regional Hub Regulatory Manager

 

Location:                           Tuas, Singapore

 

Purpose

 

This position will be responsible for execution and management of regional life-cycle submissions for all Roche products as well as new product registrations by focusing on local needs of Affiliate Drug Regulatory Affairs (DRA) teams to ensure right first-time submissions to Health Authorities.

 

Responsibilities:

 

* The incumbent will be the primary technical regulatory (CMC) point of contact for the Affiliate DRAs and as such he/she will work closely with them and the regional Supply Chain teams as well as with the PTR product managers and the PTR network.

* In coordination with global PTR Technical Regulatory Leaders (TRL), execute regulatory strategy for lifecycle submissions in Asia Pacific markets associated to management of CMC changes originating at manufacturing sites or affiliates toward maximizing efficiency, quality and rate of submission approvals by Health Authorities.

* Coordinate strategic planning with Regional Supply Chain and Affiliates DRA for change management alignment and early visibility/communication/planning of changes impacting markets in the region.

* Assemble lifecycle submissions for markets under responsibility to guarantee right first time submissions and coordinate/manage with affiliates for timely and effective submission of changes to the Health Authorities.

* Act as subject matter expert in regulatory requirements for post approval submissions and maintain the regulatory intelligence repository for regional markets under responsibility.

* Ensure timely update of the CMC change management electronic systems with the regulatory information submitted/approved externally by a Health Authority or internally by the appropriate functional area.

* Upon request, support Affiliate DRA with interactions with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert).

* Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility.

* Manage tracking of commitments with a Health Authority as result of license/dossier approval and ensure commitments due dates are met.

* The candidate may be required to travel to other Roche sites on a periodic basis.

...

PTR Regional Hub Sr. Regulatory Associate (E3) /

PTR Regional Hub Regulatory Manager (E4)1

Department: Pharma Technical Regulatory (PTR)

Job Family / Category: PTR Regional Hubs

 

Purpose

 

This position will be responsible for execution and management of regional life-cycle submissions for all Roche products as well as new product registrations by focusing on local needs of Affiliate Drug Regulatory Affairs (DRA) teams to ensure right first-time submissions to Health Authorities.

 

Responsibilities:

 

* The incumbent will be the primary technical regulatory (CMC) point of contact for the Affiliate DRAs and as such he/she will work closely with them and the regional Supply Chain teams as well as with the PTR product managers and the PTR network.

* In coordination with global PTR Technical Regulatory Leaders (TRL), execute regulatory strategy for lifecycle submissions in Asia Pacific markets associated to management of CMC changes originating at manufacturing sites or affiliates toward maximizing efficiency, quality and rate of submission approvals by Health Authorities.

* Coordinate strategic planning with Regional Supply Chain and Affiliates DRA for change management alignment and early visibility/communication/planning of changes impacting markets in the region.

* Assemble lifecycle submissions for markets under responsibility to guarantee right first time submissions and coordinate/manage with affiliates for timely and effective submission of changes to the Health Authorities.

* Act as subject matter expert in regulatory requirements for post approval submissions and maintain the regulatory intelligence repository for regional markets under responsibility.

* Ensure timely update of the CMC change management electronic systems with the regulatory information submitted/approved externally by a Health Authority or internally by the appropriate functional area.

* Upon request, support Affiliate DRA with interactions with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert).

* Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility.

* Manage tracking of commitments with a Health Authority as result of license/dossier approval and ensure commitments due dates are met.

* The candidate may be required to travel to other Roche sites on a periodic basis.

...

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 aim of this job is to support the global Business Process Owner / Head of CoE for the global Learning Solution to establish and maintain a global Learning Solution across the Roche organization, in particular in your area of responsibility. Located in South San Francisco, you provide consultation to the Business in the assigned regions and functions. You work with the local and functional Business Process Owners to ensure that the global processes and standards are embedded in the respective organizations.  In this position, you support the End-to-End Lead in identifying were process and system improvements are required and scope the   initiatives and projects. You are responsible for the delivery of assigned initiatives for your area and across the Roche world in collaboration with the CHRIS LSO servicing and support organizations.

The main responsibilities are:

• Stakeholder management and consultation to the business in the assigned regions and functions:
• North America  
• Latin America
• Middle America
• NAM and LATAM Commercial Operations
• Pharma Manufacturing (PT)
• Diagnostics Manufacturing
• Act as single point of contact for the business, functional and local BPOs
• Gather needs and areas for continuous improvement based on input from the Business,  and address those to the End-to-End Lead and global Business Process Owner / Head of CoE
• Balance local requirements for the assigned area with those of the global and group functions
• Execute the delivery of assigned initiatives (e.g. E2E) across all regions and functions in close collaboration with the CoE and business counterparts
• Liaise with the CHRIS LSO support and servicing organization on new requirements and on the delivery of initiatives
• Enforce the implementation of end-to-end processes locally and functionally (esp. where no dedicated local BPO exists)
• Provide input to global process documentation
• Support change management

...

The successful candidate will be a key member of the Cross-Portfolio Analysis & Communications (CPAC) team within PPP/Pharma Portfolio Management. The CPAC team provides management with late stage and cross-portfolio information that enables a shared understanding of the portfolio, and robust analytics that offer unique insights on Roche’s direction, strategic alternatives, and ultimately contribute to effective corporate decision-making.

Responsibilities:

• Representative responsibilities associated with the role are detailed below:
• Develop analytics around portfolio spend, future portfolio projections and “what if” scenarios
• Assess Roche’s performance versus competitors across various R&D-related metrics
• Provide guidance to, and participate in, cross-functional initiatives on R&D productivity, cost and valuation metrics, and long-range planning
• Participate in preparation of quarterly reports for senior management on progress of portfolio and implications

Job Skills and Expectations

• A strong understanding of pharmaceutical/biotech industry, drug development trends, and business strategy
• Financial acumen and understanding of commercial and development forecasting methodologies
• The ability to analyze and draw conclusions out of large, complex data sets and articulate the key findings to management and functional leaders
• Strong oral and written communication skills
• Innovative mindset and comfort with ambiguity
• The ability to build cross-functional partnerships and engage in (and at time lead) cross-functional initiatives
• A desire to make a difference and commitment and drive to see things through

...

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

Responsibilities:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

...

The Position:
Provide technical support and maintain consistent configuration, implementation, operation and support of an Integration Services Platform – Infrastructure Platforms (monitoring, inventory, automation, etc).

Responsibilities:

• Provides technical support and maintains consistent configuration, implementation, operation and support of a single Integration Services platform including:
• Implements new releases and sets up standards for operational management
• Monitors and resolves problems with Business Application operations.
• Configures and manages development, UAT and production environments.
• Administers and maintains support services.
• Configures implements and optimizes Business Applications.
• Manages incidents, problems, changes and releases
• Tunes capacity and performance
• Coordinates, tests and administers platform Security
• Complies with OLAs and Quality/Validation requirements
• Ensures ITSM framework, processes, tools and SOPs are implemented, utilized and supported end to end

Applies the processes above to the following Integration Services platform areas:

• Monitoring Solutions (NetIQ, others)
• Inventory Management solutions
• Automation and Provisioning solutions (HP Orchestrator)

Key Objectives:

• Business Application Installation and Daily Administration
• Business Application Performance Tuning
• Business Application Availability
• Support to ensure quick incident resolution
• Engineer new release and setup standards for operational management
• Standards and procedures are followed
• Understand and apply ITSM and process best practices
• Understand and comply with applicable ITSM roles and responsibilities
• Provide Support in measuring and continuously improving process performance and adherence to service level / operating level requirements.

...

Main Purpose of the Position: Provide direct manufacturing Quality Assurance support to Production (Inspection, Packaging, Aseptic Operations) in a GMP environment. Act as a key Quality contact to manufacturing for discrepancy management, batch review, and line support. Assure compliance with cGMP regulations, Roche / Genentech standards, and applicable Regulatory Guidelines. Solve routine Quality Assurance issues limited in scope and complexity following cGMP regulations and Genentech standards. Perform assigned tasks and work to achieve company goals and department objectives. Job Duties/Responsibilities: Follow company policies and procedures. Maintain a state of inspection readiness. Provide input to the development of personal performance goals and departmental objectives. Meet assigned targets and timelines with minimal supervision. Prioritize assigned tasks within a fast paced environment. Participate in process improvement and system design teams. Provide assistance to customers in support of departmental functions. Work with colleagues to maintain cross-functional and cross-site process and procedural consistency. Receive specific instruction and work independently to complete tasks. Apply basic theory and technical principles to address routine problems. Troubleshoot and assist in the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships. Sign documents for activities as MQA as described by Genentech policies, procedures and job descriptions. Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies. Perform any other tasks as requested by Management to support Quality oversight activities. Technical Duties/Responsibilities: Perform Inspection and Packaging AQLs. Perform Line Clearances for Inspection, Packaging, and Aseptic Operations areas. Initiate and close discrepancies and child records as required. Review batch records in the Inspection, Packaging, Aseptic Operations areas. Perform Assessor and Evaluation activities in the Discrepancy Management System. Interact with interdepartmental contacts on discrepancy assessment and resolution. Provide Quality oversight to internal and external customers. Review and approve controlled documents relating to processes, equipment, facilities and utilities in the manufacture of product. Collaborate with departments to ensure that all review activities are executed efficiently and effectively. Support Quality process improvement initiatives. Support the execution of departmental deliverables assigned by project teams. This is a SWING shift position: Monday, Tuesday, Wednesday, Thursday, and Friday – 4:30pm to 1:30am...

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

 

Reports to: Division Manager, Franchise Sales

 

Example Duties andResponsibilities:

*Responsible for meeting or exceeding assigned sales targets

*Develops robust territory business plans

*Develops strong and long-term relationships with customersin all assigned accounts

*Presents the assigned GNE brands in a professional,compliant, ethical and effective manner; helping external customers understandthe benefits and use of GNE brands

*Monitors operating costs and compliance with territorybudget

*Complies with all laws, regulations and policies thatgovern the conduct of GNE activities

*Business travel, by air or car, is regularlyrequired 
...

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

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

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

...

The general purpose of the Senior Manager, Commercial Training & Development role is to help structure and directly manage the development and implementation of appropriate and aligned learning & development in support of assigned functions across Commercial Operations. As such, the Senior Manager, Commercial Training & Development manages a team of assigned trainers, and/or instructional designers and other project-based or administrative staff, and does so to ensure the assigned team meets or exceeds their goals and objectives. 

The Senior Manager, Commercial Training & Development may be assigned core sales, product knowledge, marketing, or other core Commercial Operations functional skills development curricula in support of assigned Commercial Operations functions, or he/she may be alternatively assigned core aspects of a Commercial Operations-wide development segment such as cross-functional leadership or management development. Incumbents in the Manager/Senior Manager, Commercial Training & Development role, as all other employees, are fully accountable for compliance with all laws, regulations and policies that govern the conduct of Genentech activities. 

As a manager of others, the Senior Manager, Commercial Training & Development is not only accountable for his/her own compliance, but also for the compliance of all individuals in his/her team. As such, leads the way and leads by example by demonstrating full knowledge and commitment to all applicable policies. Monitors adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required. 

MAJOR RESPONSIBILITIES ¿

* Has a thorough understanding of the applications and benefits of Genentech's products.

* Determines the most effective approach to meet product learning needs of the business. Applies instructional design principles and adult learning principles to enhance content delivery. 

* Performs detailed needs assessments in coordination with Brand Sales and Clinical Trainers. 

* Translates business needs to training products and programs.

* Establishes goals and learning objectives to design appropriate and effective curriculum by leveraging adult learning principles.

* Researches the issues and leverages resources (internal and external) to support the learning objectives in designing and creating training programs and products

* Oversees the preparation of training products and programs such as classes, workshops, learning modules, e-modules, and other job aids and materials for distribution to CT&D partners and program participants.

* Skilled at group facilitation and group learning exercises.

* Implements learning and development programs based on needs assessed.

* Designs and implements metrics to measure training programs and training impact, effectiveness, appropriateness, and utility.

* Filters and distributes educational resources to CT&D partners and other appropriate audiences while remaining

contentious of legal and regulatory parameters.

* Collaborates with all CT&D partners: Sales, Marketing, Development, Medical Communications, Clinical, Legal, Regulatory, Library Services, etc. to ensure training needs are met.

* Collaborates within CT&D to ensure consistency, avoid redundancy and thereby enhance training programs.

...

The Department of Safety Assessment at Genentech provides scientific leadership and plays an active role in the process of drug development from the discovery period through marketed products.

 

We are seeking a Scientist in the Department of Safety Assessment to support drug development. This role will involve working in a collaborative team environment as part of the comprehensive safety assessment of Genentech therapeutics by providing toxicology representation to small molecule programs.

 

Responsibilities:

The successful candidate for Scientist will provide scientific leadership and play an active role in the process of drug development from late-stage discovery through marketed products. Working in a collaborative team environment, the Scientist/toxicologist leads the safety assessment of Genentech therapeutics by creating a best-evidence synthesis of existing knowledge and comprehensive investigations of toxicologic activity. The successful candidate will design and supervise toxicology studies to support the goals of small molecule project teams, work closely with Study Monitors, Pathologists, Pharmacokineticists and Pharmaceutics to deliver high quality GLP and non-GLP in vivo study reports and, as needed, represent Genentech in meetings with regulatory authorities. Responsibilities include interdisciplinary project team membership, preparation and review of regulatory documentation, study reports and manuscripts, participation in toxicology and pharmacology initiatives, and other active cross-functional collaborations. Additional responsibilities include investigations into mechanisms of toxicity, proactive management of potential safety liabilities and communication of impact to teams and governance committees. Experience with cross-functional teams and capability to build productive cross-functional collaborations both within and external to Genentech are desired.

...

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 Scientist will be a member of the Protein Analytical Chemistry Validation Department (PAC-V). PAC-V is one of the seven departments that comprise Analytical Development and Quality Control  (ADQC) organization within Process Research and Development.

PAC-V  is responsible for the validation life cycle of quality control methods (covering a wide array of techniques) until established as part of a commercial control system. PAC-V is responsible for both the development and execution of the strategies. The candidate will provide practical guidance and expertise to ensure the appropriate and timely progression of acceptable validation activities across the Protein Analytical Chemistry Department.

The candidate must have in depth scientific knowledge and hands-on experience in the development, robustness testing, and validation of analytical methods, covering a wide array of analytical techniques such as HPLC, CE, MS, and wet-chemistry. He or she will be involved to ensure the proper and timely execution of all aspects of the life cycle clinical analytical methods across Genentech's clinical product portfolio and testing sites (including CMOs and partners).

Additionally, the candidate is expected to be a key player in Genentech's business process for continuous innovation to identify, evaluate, and implement novel and viable state of the art analytical technologies for QC testing. The candidate is also expected to represent PAC-V in cross functional teams. The position involves a multitude of interactions within a global matrix organization, excellent communication and presentation skills are essential.

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