GENERAL POSITION SUMMARY/PURPOSE:¿

Regulatory Program Management 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. Like others in Regulatory Program Management, Program Managers are assigned their responsibilities by therapeutic area, and are assigned projects for different product development phases, as business needs dictate. Regulatory Program Management Program Managers support regulatory program management for one or more development projects. Regulatory Program Management Program Managers participate in and support the development and implementation of regulatory strategies to facilitate the development and approval of Roche medicines for human use. Program Managers are expected to perform their responsibilities with supervision. Regulatory Program Management Program Managers work cross-functionally and help coordinate regulatory-related activities across PDR functions and with other internal partners.

JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:

1. Intact & Cross-Functional Teams

• Participates in site and/or regional and/or global PDR Program Management departmental meetings
• Participates as a standing member in the Regulatory Affairs Functional Team (RAFT) for assigned product development projects to help ensure effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough ¿and compliant execution
• As assigned or otherwise needed, assists relevant Regulatory Program Management Program Directors with their interactions, ¿communications and planning with various other teams, dependent upon assigned projects and the associated development phase, such as early development core teams, global development teams and lifecycle teams. Helps Regulatory Program Management Program Directors coordinate cross-functional PDR contributions to product development projects and other related activities
• As assigned, may act as a standing or ad hoc member of other teams for special or ongoing initiatives and projects

2. Regulatory Program Management

• Stays abreast of internal and external developments, trends and other dynamics relevant to the work of PD and PDR to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for assigned therapeutic areas and projects. Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics. Briefs teams and management, as appropriate
• Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices
• Stays abreast of therapeutic area product development and other related business strategies and plans
• Supports on one or more regional projects at any one point in time 
• Analyzes data, the regulatory environment and business objectives to advise others on applicability of new or existing regulations and guidelines
• Participates in the development and implementation of the cross-functional regulatory strategy for each project or related assignment
• Supports Regulatory Program Management Program Directors in identifying and aligning cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment
• Supports Regulatory Program Management Program Directors and others in preparing and facilitating meetings, teleconferences and other interactions/communications with regulatory authorities. Establishes effective working relationships internally and externally with regulatory authorities
• Documents meetings, teleconferences and other interactions/communications with regulatory authorities
• Supports Regulatory Program Management Program Directors in providing internal teams with direction on regulatory authority ¿interactions
• Participates in and supports management of ongoing RAFT meetings. Including providing ongoing guidance on regulatory ¿deliverables, compliance, timing and other relevant matters. Helps manage RAFT resources, including documenting meeting ¿minutes and conducting follow-up to ensure action items are completed in a timely and thorough manner
• Helps manage project plan...

Description
The Critical Reagents System (CritRS) in Purification Development is responsible for the purification of critical reagents in support of assay development (for clinical products), assays in support of regulatory filings, the continued support of assays for marketed products, as well as specific reagents that support general test procedures (such as ELISAs to measure host cell impurities).  The candidate will be responsible for protein purification, characterization, and documentation of critical reagent production within the purification group. The work also includes interaction and collaboration with members of other CritRS production and customer groups, and potential support of other projects within the group.

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The candidate will be working in the design, performance and analysis of virus clearance studies, evaluating virus removal by protein recovery processes. Candidate will execute chromatography and/or filtration processes and perform Q-PCR, or cell-based, assays. Candidate will be responsible for scaled-down chromatography and filtration of the recovery process, as well as virus nucleic acid purification and quantification. Candidate will write GMP protocols, summary reports and execute validation studies. Depending on the business needs, candidate will support the development and implementation of recombinant protein purification process from laboratory to manufacturing scale.  The work may include purification process development, optimization, characterization, and validation. The work includes projects carried out at laboratory, pilot plant, and industrial scale using separation unit operations including column chromatography, filtration, and centrifugation. The successful candidate will also collaborate with many different functional groups and work on the development of state-of-the-art technology on viral clearance or protein purification.

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The job responsibility within the Biological Technologies group in Analytical Development and Quality Control, is to develop, qualify/validate, and troubleshoot biochemical/immunochemical and cell-based assays for clinical and to-be-marketed products.  The candidate will perform testing as needed in support of process development, stability, and lot release according to established test procedures..  Expectations will also include some routine lab maintenance, participate in writing SOPs, test procedures, and participate in training, performing testing, troubleshooting, and/or validation of immunological and cell-based potency methods.  Additional responsibilities may include presentation of data at internal meetings and participating in the evaluation of new equipment and technologies. ...

The In Vivo Studies group is seeking a team-oriented, highly motivated individual to participate in the technical conduct of in vivo studies in a high-throughput work environment. This unit of the Safety Assessment Department is responsible for the planning and execution of pre-clinical drug development studies (including pharmacokinetics and toxicology) supporting a large customer base.

Responsibilities:
Studies include (but are not limited to) work with chemotherapeutics, radioisotopes and other potentially hazardous materials. The individual will have to perform applicable techniques requiring a high-degree of manual dexterity (cannula implantation, catheter insertion, drug administration, blood collection, restraint, anesthesia, euthanasia) in common in vivo models. Maintain study-related documents and follow departmental SOPs to ensure study integrity and quality. Assume role of study coordinator for selected studies and write preclinical protocols as appropriate. This job will involve a high level of physical activity.
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We are seeking an outstanding individual for theposition of a Research Associate / Senior Research Associate within theBiochemical and Cellular Pharmacology department. The successful candidate willbe responsible for supporting research projects in the disease therapeuticareas of immunology and/or immunotherapy as part of the biologics drugdiscovery program at our South San Francisco campus. The individual will be expectedto work independently in developing and performing immunochemical, biochemical,and cell-based assays to support candidate selection, potency, efficacy, andpharmacokinetic studies as well as immunogenicity evaluation andpharmacodynamic biomarker measurements. In addition, the individual will incorporateautomation into his/her daily work and apply novel technologies in assaydevelopment.

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Position Description and Responsibilities:

A Research Associate/Senior Research Associate position is available in the Protein Analytical Chemistry Department (within US Biologics Pharma Technical Development, PTDU).  The selected candidate will be responsible for developing, optimizing, and performing analytical methods to characterize recombinant protein therapeutics and antibody drug conjugates using techniques such as high-performance liquid chromatography (HPLC), mass spectrometry (MS), and capillary electrophoresis (CE).  The individual will maintain excellent documentation of all work including laboratory notebooks, test methods, or any other appropriate documents.  Additionally, the individual will be responsible for presenting results and experimental information to departmental colleagues, writing and reviewing internal reports, and representing the department on project teams consisting of members from all areas of process development.

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A Research Associate/Senior Research Associate position is available in the Protein Analytical Chemistry Department (within US Biologics Pharma Technical Development, PTDU).  The selected candidate will be responsible for developing, optimizing, and performing analytical methods to characterize recombinant protein therapeutics and antibody drug conjugates using techniques such as high-performance liquid chromatography (HPLC), mass spectrometry (MS), and capillary electrophoresis (CE).  The individual will maintain excellent documentation of all work including laboratory notebooks, test methods, or any other appropriate documents.  Additionally, the individual will be responsible for presenting results and experimental information to departmental colleagues, writing and reviewing internal reports, and representing the department on project teams consisting of members from all areas of process development.
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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.

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The DMPK group is dedicated to enabling the discovery,development and commercialization of safe and effective medicines by elucidatingthe absorption, distribution, metabolism, excretion and pharmacokineticproperties of small molecule drug candidates. We accomplish this through theapplication of state of the art technologies and sciences of bioanalysis, drugmetabolism, drug transport and pharmacokinetics. The DMPK group works in closepartnership with disciplines such as medicinal chemistry, pharmacology,toxicology, pharmaceutical sciences, clinical pharmacology and regulatory tooptimize leads, select clinical candidates, conduct preclinical developmentstudies, support clinical evaluation and contribute to IND and NDA filings.

We are seeking a Senior ResearchAssociate/Research Associate to support Small Molecule Drug Discovery in theDrug Metabolism and Pharmacokinetics (DMPK) department.  The qualified candidate will work closely withour established team performing metabolic stability assays using hepatocytesisolated from various species, protein binding experiments in plasma, tissues,and microsomes from various species, and hypothesis-based in vitro metabolismassays to address specific mechanistic questions in drug discovery.  This person will perform weekly, fullyautomated, high-throughput, and high-capacity in vitro experiments to supportsmall molecule projects.  This personwill develop analytical methods (LC and MS/MS) to separate and detect smallmolecules and also proficient in using and troubleshooting LC-MS/MS.

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The Department is currently seeking an additional Pathologist to work with five of its Pathologists to help them support (i) research scientists who discover and develop drugs for the treatment of cancer, and (ii) research scientists and clinicians who discover and develop biomarkers for pharmacodynamics and patient selection purposes in Phase I, II and III clinical trials of oncology therapeutics.

The successful candidate will be familiar with, if not expert in, the molecular, cellular, systems biology, and pathogenic mechanisms of cancer. He/she will have a strong interest in providing pathology support for drug and biomarker discovery programs in cancer, and an appreciation for the need for potential flexibility in contributing support to programs outside of oncology as the need arises.  Depending on the candidate and the availability of resources, there may be an opportunity for the individual to spend part of his or her efforts in basic and/or translational research activities that have relevance to the company’s business goals.

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Rheumatology Brand Trainer

The Brand Trainer supports the Rheumatology Franchise (ACTEMRA and Rituxan) 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 in addition to be able to create training programs for both new hires and advanced sales representatives.
• 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.
• Develop Brand training programs as identified from Sales and Marketing teams focusing on Brand strategies and tactics which will ensure significant impact on increasing business.
• Facilitates Foundation (Phase I), Core (Phase II), and Continued (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
• Facilitation of “Selling Excellence” training programs that will enhance the effectiveness of the field sales organization
• Participates on CT&D internal training initiatives

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Position requires an experienced Human Capital Management (HCM) Technical Analyst with demonstrated work experience on multiple project and support environments.  This role will require ability to manage complex solutions in a high-pressure, fast-paced environment in close coordination with the customer.  Excellent customer orientation is critical to the role because position is face to the customer.   

Specific responsibilities include: 

• Heavy focus on end user support; Consulting related to HR system functionalities
• Collaborate with business users, end users, system architects, developers, vendors, and engineers on system solutions.  
• Day to day system administration, application monitoring and proactive issue resolution
• Analyzing and resolving IT Incident in co-ordination with Shared Service Centers (SCC) and IT partners.
• Managing standard pre-approved change requests.  Change requests will require system configuration or coordination with solution delivery team. 
• Refresher trainings (focus on usage of current functionality)
• Creating and maintaining knowledge management in close collaboration with local IT Service Desks and Employee Resource Center (HR).

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Purpose:

Job Summary:

Working in early clinical development at Genentech /Roche Inc gives the opportunity to provide translational safety contribution to projects combining good understanding and knowledge of toxicology and expertise in clinical safety and early clinical development, a very innovative approach where Genentech/Roche is a pioneer. 

Job Purpose: The Safety Science Leader (SSL) is accountable for all aspects of safety related to products in early development phase including single case assessment, aggregate reporting, integrated signal prediction/detection (ISP/ISD), integrated risk management process (ISMP) & comparative benefit/risk (in collaboration with Clinical and Regulatory) throughout the life cycle. The Safety Science Leader leads product specific safety analyses including medical evaluation, risk management, signal detection using epidemiology and other input as appropriate to ensure that adequate safety measures are implemented based on data. ¿The Safety Science Leader maintains an Integrated Safety Management Plan (ISMP) throughout the life cycle of the product or medicine and is accountable for safety components of various documents including study protocol, study reports, development study reports. The Safety Science Leader represents Safety Science in Research and Early Development teams (RED teams) . She/ He supports and facilitates transition of projects from early to confirmatory development for all aspects pertinent to safety. 

 

Primary Responsibilities and Accountabilities:

·      Contributes to scientific publications (abstracts, posters, papers) for scientific meetings/journals and approves submissions from a safety perspective. 

·      Reviews all communications to the public from a safety point of view. 

·      Keeps the EU QPPV fully informed of any changes to the benefit-risk relationship and, where appropriate, performs tasks as delegated by the EU QPPV. 

·      With the CSL and the DST, plans and performs, on an ongoing basis, an evaluation of the safety data to detect safety signals. On an ongoing basis with the team, evaluates the Benefit/risk relationship of the program and determines how to manage patients within and across trials.

·      Is accountable for safety components of all NDA documents. 

·      Is responsible for the writing and maintenance of RMP/REMS NDA documents. 

·      Represents Roche in interactions with Health Authorities and Independent Data Safety Monitoring Boards (ie Pre-BLA/NDA meetings, advisory committees) for safety related topics.  

·      Contributes to and where specifically delegated may be responsible for the proper execution of the post-approval RMP/REMS 

·      Ensures that all safety processes are properly supported and compliance is documented for all studies conducted by PD or PB or affiliates.

 People Leadership: 

·      Provides provide leadership and line management to the Safety Sciences department across multiple locations, aligning with other parts of the organization, where necessary. 

·      Ensures that the performance of direct reports is proactively managed and that they are coached, trained and developed to maximize their contributions.  

·      Allocates resources and is accountable for the assignment of his/her collaborators / reports according to their individual capabilities and in line with projects priorities.

·      Ensures that staff communication and employee relations are managed proactively to maximize the well being of employees. 

·      Actively installs the Roche values in the Safety Team and their activities.

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Purpose: 

The Safety Science Leader (SSL) is accountable for all aspects of safety related to a product in the Life Cycle Team (LCT) stage including single case assessment, aggregate reporting, signal detection, risk management throughout the life cycle. The Safety Science Leader leads product specific safety analyses including medical evaluation, risk management, signal detection using epidemiology and other input as appropriate. Accountability is partially exerted by the bringing of safety topics to the Development Subteam (DST) and, when appropriate, the Life Cycle Team (LCT) to ensure that adequate safety measures are implemented, based on data, and that CIOMS 6 guidelines are followed. 

 

Primary Responsibilities and Accountabilities:

• Contributes to scientific publications (abstracts, posters, papers) for scientific meetings/journals and approves submissions from a safety perspective. 
• Reviews all communications to the public from a safety point of view. 
• Keeps the EU QPPV fully informed of any changes to the benefit-risk relationship and, where appropriate, performs tasks as delegated by the EU QPPV. 
• With the CSL and the DST, plans and performs, on an ongoing basis, an evaluation of the safety data to detect safety signals. On an ongoing basis with the team, evaluates the Benefit/risk relationship of the program and determines how to manage patients within and across trials.
• Is accountable for safety components of all NDA documents. 
• Is responsible for the writing and maintenance of RMP/REMS NDA documents. 
• Represents Roche in interactions with Health Authorities and Independent Data Safety Monitoring Boards (ie Pre-BLA/NDA meetings, advisory committees) for safety related topics.  
• Contributes to and where specifically delegated may be responsible for the proper execution of the post-approval RMP/REMS 
• Ensures that all safety processes are properly supported and compliance is documented for all studies conducted by PD or PB or affiliates. 

People Leadership: 

• Provides provide leadership and line management to the Safety Sciences department across multiple locations, aligning with other parts of the organization, where necessary. 
• Ensures that the performance of direct reports is proactively managed and that they are coached, trained and developed to maximize their contributions.  
• Allocates resources and is accountable for the assignment of his/her collaborators / reports according to their individual capabilities and in line with projects priorities.
• Ensures that staff communication and employee relations are managed proactively to maximize the well being of employees. 
• Actively installs the Roche values in the Safety Team and their activities.

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Sales & Operations Planning (S&OP) Forecast Manager/Sr. Forecast Manager

The Sales & Operations Planning (S&OP) Forecast Manager/Sr. Forecast Manager manages and further enhances the S&OP process for the Commercial organization. This individual plays a key role in ensuring continuous supply of products to patients by collaborating with the Supply Chain organization to ensure supply and demand alignment, and to balance financial, manufacturing capacity, risk, and other considerations. The individual in this role will establish and maintain key partnerships across US Commercial, and Global and North America Supply Chain organizations.

 

Primary Responsibilities:

• Manage monthly S&OP forecasting process to ensure base case and upside demand forecasts are comprehensive, accurate and representative of the most appropriate demand plan in achieving Genentech business goals
• Prepare executive level presentations including demand analysis and scenarios to facilitate discussions and drive Executive Sales and Operations Committee (eSOP) decisions

• Develop metrics and collaborate with brand Forecast Managers to improve forecast accuracy
• Consolidate and submit demand forecasts for all SKUs of in-line and pipeline Genentech products to  the Supply Chain organization
• Prepare standard portfolio reports to provide insights to sales performance for Commercial senior executives
• Actively participate in various cross-portfolio initiatives including tools and system enhancements to support forecasting processes and reporting

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Sales Compensation Administration - Analyst / Manager

The Sales Comp Administration - Analyst / Manager role is to support the Sales Operations Incentive Compensation team for all business units / sales forces in administering Sales Incentive Compensation Programs which includes ad hoc analysis and reporting. As such the Sales Comp Administration - Analyst / Manager will be responsible for all sales compensation administration aspects including the maintenance of all sales force reference data, variable pay information, and compensation plan information within the compensation systems (TrueComp) and Incentive Compensation platforms. Additionally they will work with the Business Unit Comp Managers to collect plan design information and be responsible for the oversight of development and testing of compensation plans and rules in TrueComp. He/She will support and maintain the monthly sales and goal validation process, which requires critical thinking and problem solving skills. Candidate will also manage department SOPs, prepare department activity timelines, maintain documentation for various purposes such as program policies, eligibility, auditing & OCM purposes. Candidate will also support multiple supplemental incentive programs including the management of processing guidelines to ensure accuracy and consistency including application design & management. He/She will also help manage awards program documentation, criteria, history, inventory, etc. He/She will maintain content on IC Portals and facilitate process/data management with vendors. Candidate must have SQL skills for querying data and a basic understanding of sales compensation philosophy. Candidate will proactively coordinate with internal partners to ensure data accuracy, optimize operational processes and meet aggressive timelines. Provide adhoc support and analysis, including running queries and producing reports (using Access, Brio, Toad or other sql tool). Strong technical, stakeholder manager and communication skills are required.

 

Key Responsibilities:

 

- Primarily responsible for the administration and management of all sales incentive compensation administration deliverables including oversight of system configuration for IC plans, reference data (e.g. eligibility), timely and accurate payout processing, supplemental incentive programs, reporting and reference data management for all brands.

 

- Partner with Sales Operations Managers, Vendors and/or the Information Technology team to define data and reporting needs in support of the IC payout process and supplemental incentive programs.

 

- Collaborate with various internal and external stakeholders to ensure fairness and consistency in the implementation of and adherence to program policies.

 

- Communicate with field sales management in support of the sales incentive program payout process and provide supplemental incentive programs summaries.

 

- Development communication and reporting materials to support IC administration activities and status reports.

 

- Comply with all laws, regulations and policies that govern the conduct of GNE activities....

Overview:

 

The Sales Operations Manager role is to support the assigned business unit or franchise with regular and ad hoc business analysis and reporting of, for example, product sales, market share, market segmentation, reimbursement analysis, and/or other measures of business performance. They work closely with other team members in Sales Operations & Information Management, helping to ensure data quality, accuracy, timely and targeted reporting, optimized database and other information systems operations, which may include regular responsibilities to support ongoing operational management of the sales force automation/customer relationship management systems and processes. They also provide the assigned group with support in customer targeting, field workforce sizing, structuring and territory alignments, sales goal modeling and allocation, sales incentive compensation plan design, and/or payment distributions and administration. Given the nature of this role, they work regularly with cross-functional customers in the

assigned business unit or functional unit, such as Franchise Sales and Marketing, as well as a host of other internal partners and stakeholders, including Market Analysis & Strategy, gCOI (Genentech's Corporate Office of Information Technology), and others.

 

Key Responsibilities

• Primarily responsible for managing and training on all sales operations deliverables including operations launch planning, analytics, reporting, targeting, alignments, Incentive Compensation and Sales Force Automation for their assigned brand(s)
• Partner with sales management and Field Sales Operations to define and produce analytics that support the business objectives and strategies. Provide periodic reports and detailed analysis to identify drivers behind trends and potential business opportunities
• Develop communication materials to support field sales management on business reviews and sales force tools
• Support and respond to field sales inquiries around data
• Collaborate in the management of all IC operation activities including goal allocation, goal adjustments, IC reports. Partner with Compensation Administration team to validate and process incentive payouts, assess and provide impact on issues affecting field incentive plan
• Collaborate with the Information Technology team to define business requirements and solutions for all tools and deliverables that support the field sales force
• Comply with all laws, regulations and policies that govern the conduct of GNE activities

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