Purpose

To provide relevant, balanced, and timely evidence-based clinical information on Genentech products to managed care customers that make decision regarding drug coverage and reimbursement, .

Description

The Associate Scientist or Scientist for Managed Care Medical Communications (MCMC) is able to communicate relevant and timely clinical information on our marketed products and compounds in late development.  More specifically, this position is responsible for communicating effectively with external customers involved in evidence-based healthcare decisions including but not limited to managed care organizations, private and government health plans, third party payors, pharmacy benefit managers, specialty pharmacies, compendia publishers, guideline bodies and technology assessment entities.  The MCMC Associate Scientist/Scientist is expected to evaluate and interpret medical literature, abstract and write medical information in various response formats, conduct scientific and clinical presentations, and apply managed care concepts and knowledge to customize our services for managed care customers.  More specifically, an understanding of the comparative effectiveness research (CER) and health technology assessment (HTA) landscape is required, as well as the ability to review, assess and synthesize CER, health outcomes research and pharmacoeconomic evidence.  Medical information is prepared and communicated using many formats (response documents, formulary dossiers, slide presentations, compendia submissions, web-based media, scientific meetings, etc.).  This position is also involved in the review of promotional marketing materials intended for the managed markets and payor environment.  The MCMC Associate Scientist/Scientist shall effectively, appropriately, and responsibly use resources to support the use and access of our marketed products.  

The MCMC Associate Scientist/Scientist may contribute to departmental efforts to develop, implement or further improve business processes and operations.  This may include non-clinical and non-product types of responsibilities and activities such as systems and technology, training, quality assurance, writing policies and procedures.  Some business travel is expected.

Candidates should have a sound understanding of legal and regulatory topics to adequately describe the basis of Medical Communications (MC) policies and practice.  He/she must work effectively with members of the MCMC/MC staff and other internal customers that include but are not limited to: Medical Directors, Health Economics and Outcomes Research, Managed Care Liaisons, Project and Execution Managers, Regulatory, Legal, Managed Care Marketing, Field Managed Care, Medical Science Liaisons, Sales, Marketing, Access Solutions Reimbursement, and Corporate Partners.  This position shall partner with these entities to meet the information needs of managed care customers, contribute to corporate wide goals, and support the safe and effective use of Genentech products.

  Manages the implementation of Medical Data Review, both processes and application of the tools by Clinical Scientists, by providing on-site training, development of best practices, and dedicated support.  The person in this position optimizes the implementation of Medical Data Review by being an integral member of the MDR support network.

Main Responsibilities:

Provides training for medical data review tools

• Owns the scheduled training program and ad hoc on-the-job training
• Provides class room training/ one on one training as required
• Assists with the access process to medical data review tools and provides guidance
• Ensures tool users understand the data source(s) used for report generation, and assists with identification of questionable or discrepant content (includes some UAT)
• Contributes to the co-ownership of the standard training materials for MDR tools (e.g. J-Review)
• Co-develops applied job aids to support end users in use of the tools (e.g. tips and tricks sheets)
• Maintains real-time training attendance records
• Updates materials as systems undergo changes and alerts end users of changes as they occur

Provides support for medical data review

• Acts as a main point of contact for Clinical Scientists with questions on Medical Data Review processes and documentation
• Acts as the main point of contact for CDM report developers and Informatics (e.g. for specification set up and UAT)
• Acts as a main point of contact for teams engaging with CROs for MDR of external data and champions the standards used with vendors
• Provides guidance and actually develops ad hoc report objects to support ongoing MDR
• Actively solicits input from users to identify areas requiring additional support

• Delivers desk-side first level system support to end users, and understands when resolution requires escalation

• Participates in meetings with tools’ owners to ensure end users requirements are met
• Co-maintains an on-line PDC communication/document repository

Tracks system compliance

• Monitors tracking reports for tool compliance and performance of reports
• Reviews and provides the Informatics team with regular updates on status and metrics using standard/automated reports

Provides input into the global development of best practice for MDR

• Promotes knowledge sharing across the Function and within Therapeutic Areas to improve MDR best practice
• Provides input into the development of best practices of MDR Tool use and advises on the optimal use of standard tools and templates
• Proactively gathers change requests for new/different report objects or changes in processes or standard templates
• Supports the set up and maintenance of report objects built per study for medical data review
• Encourages and champions standard report objects wherever possible (cross program/TA)
• Proactively incorporates learning and recommendations from users
• Contributes to activities for improving and maintaining the quality and effectiveness of tools within Clinical Science.
• Participates in local and/or global initiatives that focus on the tools
• Makes recommendations for improvements to Informatics and Developers
• Partners with end users in proposing creation/revision of report objects
• Uses Informatics, Developers of tools for information and knowledge based resource
• Shares information across the MDR Specialist team and MDR Network
• Maintains oversight of external available tools and functionality

System support management

• Reviews and approves relevant System Development Life Cycle documents
• Contributes to future upgrades and assessment for improvements, new releases, replacement software
• Provides proactive support in terms of communication regarding updates and best practice

• Provide QA oversight, support and execution of validation/qualification activities pertaining to Investigational Medicinal Products (IMP, a.k.a. clinical) GMP manufacturing equipment and analytical instruments, including preventive maintenance and requalification activities.
• Provide technical review and approve quality risk management and validation/ qualification deliverables for small molecules and biologics equipment qualification, ensuring proper design and execution.
• Ensure that equipment and systems remain in a validated state, and that validation master plans and their related documents are accurate and current.
• Develop strategies and act as project manager for new projects in collaboration with system owners.
• Develop near-term and long-range plans for the department in collaboration with Senior Management.
• Provide technical assessment and approval for GMP changes.
• Assess equipment-related discrepancies and provide input to investigations.
• Apply expertise of compliance requirements to maintain an inspection-ready state.
• Participate in audit/inspections as a subject matter expert.
• Support implementation and provide stakeholder feedback and input to the integrated Pharmaceutical Quality System (PQS) documents.
• Perform tasks and work to achieve company goals and organizational objectives.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Provide guidance to internal and external customers on best practices for generating and executing validation protocols.
• Provide input into investigations involving GMP related failures.
• Develop and implement process and system improvements, including contributing to the development of new concepts, techniques and standards.
• Advise other IMP QEV staff members on Validation related processes and projects.
• Supervise/oversee temporary or contract staff, as required.

The Senior Finance Business Partner will support senior leaders in Technical Regulatory and Quality and Compliance (RQC).  Quality & Compliance, the broadest Functional Unit of the PT network, spans the Biologics, Small Molecule and Contract Manufacturing Operating Units.  As a business partner, you will contribute a business perspective as a member of the leadership teams and drive the planning, reporting and ad hoc financial analyses to support each of these leaders and their teams.  This position is focused on global controlling but has significant local controlling responsibilities, too.  The successful candidate will be seen by his/her business partners as a thought leader in financial issues and a “go to” person for financial / business advice. 

This position, based in South San Francisco, will report to the Head of Finance, Quality & Compliance and Technical Regulatory, located in Basel, Switzerland.

MAJOR RESPONSIBLITIES 
• As a contributing member of numerous leadership teams, provide business partner support to South San Francisco based Technical Regulatory and Quality & Compliance leaders and their respective global leadership teams. 
• Partner with RQC leadership to understand and seek new business drivers and key operational issues; actively identify tactical and strategic opportunities; contribute to the development of appropriate financial and performance metrics; recommend decision frameworks and present to senior management.
• Lead RQC global functions’ planning and forecasting exercises.
• Provide accurate and timely monthly management reporting.
• Provide decision-support analysis to management on projects and initiatives.  Leverage technical financial knowledge and available data to ensure analyses are well founded and thorough.
• Develop logic, models and presentation material for demonstrating/communicating value proposition for services provided by Regulatory, Quality & Compliance evaluating business need and significant changes within PT and Roche.
• Work closely with Accounting and Global FMT resources to ensure that RQC global functions’ financial and accounting data are accurate and aligned with principles governing technical operations including GAAP and IFRS (FGAR).
• Work with Capital Planning to ensure RQC needs are communicated and included in the Capital budget, forecast and business plan exercises.

Supervisor

• Manages the daily workflow, ensuring adequate coverage is available
  on a daily basis
• Performs ongoing analysis of existing operations and implements new functions and tactics as required
• Identifies trends/obstacles for distributor/vendor relationships and
  reimbursement activities
• Keeps current with applicable laws, regulations and policies that
  govern the conduct of activities and ensures staff members are
  adhering to these guidelines
• Maintains timely and effective communications with management
  regarding departmental issues
• Investigates and responds to customer complaints while concurrently
  instituting necessary improvements to avoid recurrence
• Ensures accountability for project timelines and SMART goals
• Provides staff with clear expectations, consistent direction, coaching and feedback
• Provides first line of support for escalated calls and external
  customer support issues
• Provides managerial support internally and externally
• Sets performance standards and conducts staff performance evaluations
• Identifies and communicates vision and strategy to team
• Identifies internal and external training requirements
• Works with internal business partners/stakeholders to understand
  their strategies and goals for integration into departmental goals and
  objectives
• Works with Planning Ops as appropriate to develop departmental budgets
• Creates, disseminates and directly manages special projects, audits
  and reports for team
• Identifies and undertakes a variety of special projects aimed at
  increasing effectiveness and finding efficiencies; also participates
  on cross-functional teams that help further operational success
• This position may require some travel and flexibility in work shift

Main Purpose of the Position

Description:  This Site Manager will manage the Production oversight related to sterile drug products manufactured at a Contract Manufacturing Organization (CMOs) located in Greenville, North Carolina.  This person will be a team leader on a CMO governance team to support right to operate and supply of critical biologic products, including a product launch.  

* Manage the lifecycle of contract manufacturing activities for commercial products at one or more bulk drug product (DP) third-party contract manufacturing organizations (CMOs), including CMO selection, process technology transfer, routine cGMP manufacturing, and site decommissioning upon completion of the contract.  

* Establish and maintain alignment between CMO site business, operational and quality objectives and plans and Roche/Genentech’s commercial and manufacturing strategies and plans.

* Establish and manage business, operations, and quality relationships and communications between Roche/Genentech and the CMO as a point of contact for the contract manufacturing relationship at the Joint Management levels.

* Lead cross-functional teams of technical, quality, regulatory, manufacturing, engineering, supply chain and other subject matter experts to achieve CMO site business, operational and quality objectives, plans, and performance goals.

* Provide the single point of accountability for identifying and managing timely resolution of business, operational, and quality issues through the established CMO site governance structure.

Job Duties/Responsibilities 

Contract Manufacturing Lifecycle Management

1.   Selection.   Lead the Roche/Genentech cross-functional team charged with for identifying, evaluating, and selecting and negotiating a contract with a CMO for bulk contract manufacturing, specifically:

* Develop CMO selection plan, define contracting manufacturing requirements and evaluation criteria, and identify and screen CMO candidates.

* Develop Request for Proposals (RFPs), and solicit and evaluate contract manufacturing proposals.

* Participate in and/or Lead due diligence visits, analyze and evaluate CMO proposals, and develop recommendation(s) for CMO selection.  Drive decision-making for CMO recommendation through appropriate governance committees.

* Lead contract negotiations for technology transfer and manufacturing and supply agreements.

2. Implementation.  Lead the cross-functional team charged with transferring, qualifying, and achieving regulatory licensure the process and analytical technologies (“technology transfers” for manufacturing Roche/Genentech’s DP products at a CMO’s manufacturing facility, specifically:

* Lead the Technology Transfer project for Roche/Genentech through regulatory licensure of the CMO’s facility for routine cGMP manufacturing, including potential to serve as the Leader of the Joint Management Team.

* Plan and manage the transfer of Roche/Genentech’s DP manufacturing process(es), analytical testing technologies, and supply chain processes to achieve product and process comparability between the donor and receiving sites.

* Manage the project governance structure, including identifying and managing issue resolution and milestone stage gate reviews.   

* Oversee and manage contractual commitments, obligations, and processes, including milestone dates, financial terms, dispute resolution, and materials and equipment.

3.   Site Management. Lead the cross-functional team charged with managing contract manufacturing at CMO following regulatory licensure, specifically:

1.1. Business

* Serve as Roche/Genentech’s Site Manager, actively managing the on-going relationship with CMO to ensure Roche/Genentech’s expectations for product quality, cGMP compliance, costs, and production targets are clearly understood, well-documented and consistently met.

* Lead project team meetings and technical operations meetings.

* Coordinate and manage visits and contact between Roche/Genentech personnel and the CMO.

* Establish and maintain a Joint Service Agreement with the CMO that defines roles and responsibilities, business processes, systems and tools, supply chain assumptions and standards, and performance metrics to foster an effective and efficient business relationship. 

* Manage and monitor contractual commitments, obligations, and processes, including milestone dates, financial terms, schedules, materials, and equipment.

1.2. Operations

* Serve as site Technical Lead, coordinating technical review of process data and proposed facility, equipment, system, or process changes with Roche/Genentech Subject Matter Experts (SME's).

* Facilitate issue resolution and problem solving within CMO site, with Roche/Genentech functional departments suppor...

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

Requirements:

• Provide statistical expertise to multiple nonclinical areas, including projects in research, preclinical studies, assay development, bioprocess development, quality control, and manufacturing.
• Propose experimental design and analysis strategies, perform statistical analyses, and collaborate with investigators to ensure the statistical integrity of nonclinical reports.
• Support regulatory submissions and investigations.
• Build strategic partnerships with collaborators and promote statistical thinking in decision making in nonclinical areas of drug development.
• Provide advice and training on the use of statistical methods and software packages to nonclinical investigators within the company.
• Develop and deliver statistics courses to nonclinical audiences
  Collaborate with scientists in support of external publications.
• Keep abreast of new developments in statistics, drug development, and regulatory guidance through literature review, conference attendance, and professional activities.

The QA Product Technical Manager is the key point of contact for all issues affecting the disposition of their assigned product(s). This individual will be responsible for interacting with multiple departments within Roche to assure that all lot disposition issues are identified and resolved within standard lead times.
• 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.
• Collaborate with Management to establish and meet targets and timelines.
• Support routine operations and allocate assigned resources.
• Manage competing priorities.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Lead and participate in the design and implementation of department and cross-functional initiatives.
• Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems.
• Troubleshoot and direct 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.
• Train personnel and internal customers on relevant business processes.
• 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:
• Oversight of the activities associated with dispositioning of assigned production lots within established standard lead times.
• Management of lot disposition activities to ensure that products are dispositioned in accordance with regulatory requirements, cGMPs and Genentech policies and procedures, within established standard lead time.
• Interfacing with appropriate departments or manufacturing plants to ensure that lot disposition items are completed.
• Notification to Senior Management for all known delays in meeting established standard lead times or any potential significant quality issues.
• Interfacing with QA Lot Disposition Supervisors and Final Reviewers to ensure that final review activities are completed. Lead and provide guidance to Final Reviewers as required.
• Perform a review of investigations for potential cumulative effect to a batch history record.
• Perform a review of QC out of trend results for cumulative effect.
• Provide assistance to CMC teams by addressing lot disposition issues as they arise.
• Support regulatory inspections as needed.
• Assess batch history records as part of investigations into product complaints.
• Revise and approve applicable lot disposition documents as needed.

As a Principal Staffing Consultant, you will play a lead role in managing the recruiting and hiring programs for our Product Development Staffing 

Main Deliverables:

1. Play a lead recruiting role for approximately 100 positions annually, with an average requisition load of 30-40.
2. Play a lead role in key Product Development  wide staffing initiatives, including those supporting our diversity and hiring best practices programs
3. Partner actively with HR Management to drive internal talent development and succession planning programs
4. Provide original thinking to staffing challenges and execute on ideas for improving patterns of work

Main Accountabilities:

• Deliver Recruiting Results
• Recruit with Insight and Strategy
• Innovate and Expand Possibilities
• Value Collaborations, Communication, and Teamwork
• Execute on Tactics, Tools, and Technology

Full Responsibilities:

• Managing expectations of hiring managers and candidates, identifying and resolving issues
• Drive the employment process and strategies within assigned organization, including developing complex recruiting strategies
• Demonstrate thorough understanding and adherence and enforcement of internal staffing process as well as contribute to the development of staffing process improvements
• Ensures recruiting solutions are consistent with Corporate Staffing goals and objectives
• Partner with Diversity and sourcing counterpart to develop and implement sourcing plans and strategies for your client groups while ensuring that the elements of diversity and organizational fit are included in the recruiting and hiring process
• Proactively manage escalation process related to all requisition activity (internal vs. external challenges)
• Perform executive recruiting, including identifying appropriate Contingency or Retained Search firms, maintaining relationships and partnering to ensure that candidates are interviewed expeditiously
• Develop advertising strategies for specific groups and coordinate advertising activities with recruitment advertising agency
• Build and maintain cross-functional relationships across HR and Staffing
• Utilize, update and maintain applicant tracking system and CRM
• May provide staffing reports and metrics
• Present information on results and metrics at different levels (i.e. to employees, peers and senior level HR and client groups)
• Act as point person for clients in providing staffing reports and metrics
• May Lead and or participate in HR related projects or enterprise wide initiatives.
• Partner with Client Group on internal talent management, including succession planning, talent review and internal candidate movement
• Coach managers in providing feedback to candidates, developing offers, determining competencies, coordinating and training interview team
• Partner with Diversity and HRDs to develop and implement a recruiting strategy that ensures our candidate pipelines are diverse
• Conduct interviews using in depth behavioral and skills assessment techniques
• Educate hiring managers on legal implications in hiring
• Adjust the strategy and align it with the changing needs of the business
• Ensure your compliance with EEOC/OFCCP regulations
• Act as project manager for client focused staffing projects (not just req focused)
• May partner with finance in determining headcount for client group, as well as manage the reconciliation of budgeted headcount vs. actual headcount
• Work with Staffing Manager on recommendations for the EC Group recruitment/relocation budget
• Oversee relocation/recruiting budget for individual client group at the officer level
• Manage multiple relationships, both internally and externally
• Attend professional conferences and networking events
• Responsibility for Conference/Event management related to external recruiting, partner with Corp Staffing in strategic direction of event, and determine ROI for event participation

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.

Job Duties/Responsibilities:

• Perform microbiological, biochemical and analytical lot testing of raw materials, E. coli and mammalian cell banks, commercial and clinical fermentation, purification, and final product samples according to GMPs.
• Review data and assess against established acceptance criteria. 
• Evaluate data to identify trends and/or establish limits. 
• Identify gaps in and potential improvements to systems and procedures. 
• Perform equipment qualification and or maintenance. 
• Prepare and maintain standards, controls, stocks, and cultures per established procedures. 
• Assure and apply GMP throughout all operations. 
• Coordinate with customers to support multi-site operational activities. 
• Present analytical procedures and results during internal and external audits and regulatory inspections.
• Participate in and/or lead projects and process improvements. 
• Perform other duties as requested by managers to support Quality activities. 
• Works to meet schedules, timelines and deadlines. 
• Meets scheduled performance of 95% on time.

Technical Duties/Responsibilities

• Write technical protocols and reports under limited supervision. 
• Identify and propose resolutions for study or project deviations. 
• Provide input to and participate in assay transfer and assay validation.
• Perform technical review of data derived from complex tests. 
• With limited supervision, design and execute quality investigations and CAPA (corrective actions preventive actions) initiatives as needed. 
• Identify, troubleshoot, and propose resolution to technical problems. 
• Identify and propose resolution for discrepancies. 

Oral Octreotide Brand Trainer
*Position is based in SSF headquarters

The Brand Trainer supports specific brands in which the responsibilities are a combination of Clinical Trainer and Sales Trainer. Therefore, the Brand Trainer must possess a thorough understanding of the assigned brands product(s) in addition to be able to create training programs for both new hires and advanced sales representatives.

Major Responsibilities:

• Determines the most effective approach to meet product-learning needs of the specific brand business. Applies instructional design principles and adult learning principles to enhance content delivery.
• Establishes goals and learning objectives to design appropriate and effective curriculum by leveraging adult learning principles.
• Researches the clinical issues and leverages resources (internal and external) to support the learning objectives in designing and creating training programs and products.
• Prepares and/or oversees the preparation of clinical training products and programs such as classes, workshops, learning modules, poster books, and other job aids and materials for distribution to CT&D customers and program participants.
• Develops Brand training programs as identified from Sales and Marketing teams focusing on Brand strategies and tactics that will ensure significant impact on increasing business.
• Facilitates Foundation (Phase I), Core (Phase II), and Advanced (Phase III) Training Classes – skilled at group facilitation and group learning exercises.
• Designs and implements metrics to measure clinical training programs and products impact, effectiveness, appropriateness, and utility.
• Filters and distributes educational resources (i.e. clinical papers) to the CT&D customers and other appropriate audiences while remaining contentious of legal and regulatory parameters.
• Collaborates with all CT&D customers and resources: Sales, Marketing, Development, Medical Communications, Clinical, Legal, Regulatory, Library Services, etc. to ensure consistency, avoid redundancy, and that needs are met and leverage internal resources thereby ultimately, enhance training programs.
• Communicates appropriate Commercial Training and Development (CT&D) programs and resources to all customer segments to help support the Commercial Organizations strategic goals.
• Participates as an active member on Commercial and Brand product teams
• Facilitates “Selling Excellence” training programs that will enhance the effectiveness of the field sales organization
• Participates on CT&D internal training initiatives

The successful candidate will be involved in late-stage pharmaceutical development ofmonoclonal antibodies, antibody-drug conjugates, and delivery systems for clinical evaluation and commercialization. The responsibilities of this role include formulation development, evaluating product stability and throughout the manufacturing process and performance in diverse delivery systems, as well as biophysical characterization, drafting technical documents and contributions to regulatory filings. Applicants should be comfortable working both independently with minimal supervision and as part of a team to support the development of recombinant protein therapeutics. The successful candidate will also be expected to participate on cross-functional project teams. The position offers opportunities for professional and scientific growth in a dynamic, intellectually stimulating and fast-paced work environment.

The Position

• Perform final review, cumulative review and disposition of Genentech manufactured cell banks and clinical drug substance, drug product and final drug product.
• Review and approve procedures, tickets and other clinical QA controlled documentation. 
• Provide clinical trial support such as COA/COC/COT requests.
• Provide support and oversight of manufacturing activities on the floor.
• Manage batch disposition activities to ensure that products are dispositioned in accordance with cGMPs, Regulatory, and Genentech Policies and Procedures and adherence to schedule.  
• Set personal performance goals and collaborate with management to establish organizational objectives.  
• Manage competing priorities to meet department and organizational targets and timelines.
• Serve as the Quality representative on cross-functional and multi-site teams.
• Identify, design, and implement process and system improvements.
• Apply advanced theory, technical principles, and judgment to address a broad range of difficult problems.
• Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance
• 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.
• Interface with appropriate departments to ensure that batch disposition items are complete and timely notification to Management of all known delays and significant Quality issues is provided
• Interact with interdepartmental contacts on discrepancy assessment, resolution, and Quality approval
• Support and present in Internal and Regulatory Inspections.
• Participate in the resolution of Quality issues by fostering effective interdepartmental and cross-functional relationships.
• Participate or lead different internal or cross functional projects relevant to QA lot disposition
• Train new personnel and internal customers on relevant business processes.
• Ability to revise or create work instructions, SOPs and business process instructions.