• Organize and facilitate teams to critically review current business processes for quality, simplification and effectiveness and to identify requirements requiring cooperation and support from cross-functional stakeholders/business partners, establishing links between business strategy and process improvement initiatives and use of systems.
• Develop procedural documents, working documents and clinical study manuals in compliance with regulatory requirements and global processes.
• Routinely prepares reports by collecting, analyzing and summarizing information to support portfolio planning and study management activities and decisions.
• Collaborates with local or global reporting teams to create USMA specific reports to ensure accurate data is reported to management and enable good business decisions to drive business success.
• Collaborates with USMA stakeholders and other business partners to ensure appropriate documentation and integration in to process maps.
• Regularly attend cross-functional staff meeting to present system and processes project and process improvement activity status.
• Represents USMA on global systems/processes initiatives contributing to maximize functionality and ensuring alignment.
• Serve as internal advisor to address systems/process related questions and gather information to distinguish requests from true business needs.
• Develops tools, templates and procedural documents to support the tactical application of business processes as required.
• Routinely solicits feedback from users on systems and process enhancements, training and other ways of driving more effective systems/processes integration.
• Provides input to training programs and team effort by accomplishing related results as needed.

Clinical Data Management (CDM) is a department within the Biometrics function of the Product Development (PD) organization.   CDM provides data management expertise to study management teams in PD and in gRED (Genentech Research & Early Development).

RESPONSIBILITIES:

The Study Data Manager (SDM) is a core member of Study Management Teams and serves as the study data management contact at the study and/or program level, providing expert guidance to program teams.  The Study Data Manager leads the CDM study team and maintains oversight of all study start-up, study conduct and study close-out data management issues, activities and deliverables for one or more studies.   The SDM interacts regularly with Clinical Data Management groups to ensure that project objectives are understood and met and provides technical coaching and mentoring on data management activities to colleagues.  The SDM also performs the following: provides early strategic input into protocol design focused on data management issues; leads the development of eCRFs and database development and testing specifications by interacting with other functional area representatives;  responsible for the oversight of all data review and cleaning activities involving close interaction with project clinical research professionals; responsible for the implementation of standards within Study Data Management across one or more CDM study teams; develops and executes ad hoc database queries utilizing data review and query tools;  manages projects resourced externally via contract research organizations or corporate partners; provides support to ensure that study conventions, processes, knowledge sharing and best practices exist across all studies within a program; participates in departmental discussion groups, formal working groups or special projects.  

The Senior Clinical Coordinator, Franchise Sales bringsclinical knowledge and expertise to the assigned franchise sales team.  The Senior Clinical Coordinator helpsclinical specialists and their customers increase their knowledge andunderstanding of the assigned GNE brand(s); their benefits and use as thesepertain to the relevant therapeutic area/disease state and approvedindication(s).

Reports to: Clinical Coordinator Field Manager

Example Duties andResponsibilities:

*Participates in territory/division/regional businessplanning

*Recommends opportunities to increase account knowledge ofGNE brand(s)

*May provide input into marketing materials

*Actively participates in local clinician groups

*Provides training and education sessions regarding GNEbrand(s) and their approved indication(s). Uses approved training/education materials

*Supports clinical specialists in other ways/means byattending periodic account meetings; helping to further increase accountknowledge of GNE brand(s)

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

CORA 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. CORA Program Directors chair moderate to higher complexity Promotional Review Committees (PRCs), for different products and product development phases, as business needs dictate. CORA Program Directors are responsible for leading and managing the assigned PRCs and their activities; providing strategic and operational leadership in the areas of advertising and promotion for Roche pharmaceutical products and devices. Associate Program Directors are expected to perform their responsibilities with increased independence. 

Intact & Cross-Functional Teams:

• Participates in site, regional and/or global CORA departmental meetings 
• Leads assigned PRCs
• As appropriate, participates as an ad hoc member in the Regulatory Affairs Functional Team (RAFT) for relevant products. Represents CORA and supports effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution

Commercial Regulatory Affairs:

• 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 Roche therapeutic areas and products. Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics 
• Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices 
• Maintains current awareness of evolving health authority interpretations; including advisory letters, enforcement letters and policy issues.  Communicates significant changes or other relevant matters to internal partners and stakeholders 
• Facilitates the timely development and approval of disease state and promotional materials by interpreting and applying regulations and guidelines from health authorities and Roche policies 
• Manages the development of relevant correspondence with health authorities and interpretation of health authority comments, as well as serving as the primary Roche liaison with relevant personnel in marketing, advertising and communication offices within health authorities 
• Chairs PRC meetings and effectively collaborates with cross-functional internal groups and external advertising agencies 
• Participates in commercial meetings to provide a regulatory perspective on marketing strategies, implementation and promotion objectives 
• Develops and implements effective strategies for health authority marketing, advertising and communications submissions 

• Close collaboration/partnership with the Product Development operational staff
• Facilitation of subject matter experts within and outside PDG
• Close liaison with PDQ (global quality group)

• Continuous Improvement
• Training Compliance
• Facilitation of simple aligned business processes
• Inspection Readiness and supporting Sponsor inspections
• Records compliance

• Representation of DMPK at interdisciplinary project teams
• Pharmacokinetic data analysis and modeling
• Set-up and validation of in vivo ADME/PK models

The Country Study Manager (CSM) provides leadership to one or more Study Management Teams (SMTs) and provides strategic planning and organization to achieve successful study completion. The CSM maintains full ownership of the US Medical Affairs portion of a study and ensures the effective and efficient delivery of the operational aspects in accordance with the medical plan and ICH/GCP standards, Roche SOPs, local operating guidelines and local regulatory requirements. The CSM also ensures the development and maintenance of productive relationships with our customers.

Responsibilities:

- Provides Direction and Leadership to one or more SMTs

- Establishes Study Timelines, Budget, Resource, Risk and Quality Plans

- Manages the Delivery of Study Activities in Order to Meet Study Plans

- Builds effective, high performing SMTs through influence, integration, motivation and optimization of team performance.

- Develops and maintains effective working relationships with, and is the primary contact for, key stakeholders, eg, Pharma Business

- Functions as Study Management Team Leader.

- Maintains awareness of external clinical research practices to ensure the SMTs are aware of the risks, priorities, value and impact of their work and contributions.

- Provides input into the study synopsis, development of the final protocol, feasibility conduct and all study specific documents and procedures.

- In accordance with the overall medical plan, establishes and maintains accurate study level plans in designated resourcing and planning system.

- Is accountable for the development and active management of the study patient recruitment strategies in US Medical Affairs.

- Develops Partnership with Business, participates on local life cycle teams, consults local Business Units, and participates in local Business Unit meetings as necessary.

- Is accountable for the selection, training and direct management of external suppliers supporting US Medical Affairs trials.

- Ensures that data is delivered in accordance with established dataflow timelines.

- Develops/maintains investigator relations, builds and maintains a professional relationship between Roche and Investigator, participating in Investigator Meetings as necessary.

- Monitors progress against SMT goals and takes appropriate action to ensure goals are met and issues are communicated with the appropriate persons or teams.

- Oversees the management of the Clinical Operations studies budget.

- Leads the evaluation of standards across one or more SMT(s) with the objective of enhancing quality, productivity and efficiency. 

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.

This position may be filled at an Audit & Analytics Manager, Contract Services or a Senior Audit & Analytics Manager, Contract Services

Audit/Senior Audit & Analytics Managers play a leadership role in assuring Contract Operations full and consistent compliance with business, legal and regulatory requirements that govern contract services and customer partners for all commercial and relevant government programs and contracts. Audit & Analytics Managers perform internal audits and manage external contracted customer and 340B entity audits. In addition, Audit & Analytics Managers gather, analyze, synthesize and provide partners and stakeholders with compliance and audit related-data to support ongoing business operations and decisions, which includes identifying and interpreting trends that emerge from internal and external audits and communicating these findings and implications to partners/stakeholders. Given the nature of their work, Audit & Analytics Managers act as subject matter experts (SMEs) on SPCM Contract Operations processes, collaborating with Contract Operations partners and stakeholders in various meetings, initiatives and projects. The audit responsibilities of this position are critical to ensuring the integrity, accuracy and compliance of Contract Operations processes and activities and external contracted customer compliance. Senior Audit & Analytics Managers are expected to play a leadership role in guiding overall compliance operations and practices across Contract Operations. As such, Senior Audit & Analytics Managers may have one or more direct reports and they also share some of the other departmental management activities with their manager, e.g., reviewing the work of others, representing Contract Operations compliance to cross-functional teams, partners and stakeholders, preparing and delivering senior management presentations on strategic or complex issues, and leading strategic projects.

• Acts as a lead SME for Contract Operations and customer audit compliance and SOPs
• Proactively seeks out complex information on changes in laws, regulations and other external factors and dynamics. Works with manager and other internal partners/stakeholders to interpret the information and assess its effect on current Contract Operations systems, processes and practices. Develops appropriate responses, including recommending changes to general and/or auditing and analytics practices to assure Contract Operations’ ongoing compliance and accuracy
• Plays a lead role in development, implementation and ongoing maintenance of Contract Operations SOPs
• Develops, recommends, implements and educates others on performance metrics for Contract Operations general and audit-specific practices
• Oversees and ensures timely and targeted development and delivery of Contract Operations Compliance & Analytics training; including conducting training for other staff members and, as appropriate, others outside of the department
• Leads other project initiatives
• Serves as the primary point-of-contact for SPCM Contract Operations’ compliance and auditing. Includes all compliance-related initiatives and representing Contract Operations’ and customer compliance and audit activities to internal and external partners and stakeholders
• Serves as an expert on all applicable laws, regulations, corporate and business unit standards and requirements and helps drive cross-functional operations to assure compliance, accuracy and achievement of all other key performance metrics for Contract Operations
• Works with other audit managers and internal process SMEs to ensure proper process controls are in place
• Oversees or otherwise supports internal and external audits by organizing, compiling and storing necessary data and creating reports and presentation materials
• Oversees and conducts timely and targeted internal auditing and validation to ensure compliance, as per Contract Operations SOPs and other business, legal and regulatory requirements
• Partners with 340B field account management teams to provide auditing, analysis, reporting and communication support for 340B Program Integrity
• Provides expert post-auditing guidance and advice to cross-functional partners and stakeholders and, where applicable, plays a lead role working with SMEs to identify root cause and develop process-driven solutions and corrective action plans
• Where applicable, closely monitors corrective action plan implementation to assure timely, thorough and compliant follow-through
• Oversees or otherwise performs analyses and provides reporting to identify trends and interpret data related to Contract Operations and customer compliance and auditing activities 
• Plays the lead role in presenting audit and corresponding analytical findings, insights and recommendations to stake...

The Department of Small MoleculePharmaceutics in Genentech Research and Early Development is seeking a highlymotivated Senior Scientific Manager to lead an effort in pharmaceuticalprofiling and development, during preclinical and early clinical assessment, ofnovel small molecule therapeutics for unmet medical needs. The successfulcandidate will head a small group of scientists, and is expected to:

• Provide exceptional scientific leadership within Small Molecule Pharmaceutics, as well as to other functions, subteams and teams at Genentech

• Develop and effectively manage a small laboratory group focusing on selection, profiling and advancing small molecule clinical candidates in a scientifically rigorous, phase-appropriate manner 

• Drive scientific and technical innovation collaboratively with other members of the Department

• Develop and execute preformulation and formulation strategies based on strong scientific rationale and pharmaceutical/biopharmaceutical properties of the molecule for one or more projects

• Author development reports and relevant CMC sections for regulatory filings

• Publish in high quality scientific and pharmaceutical journals

• Participate and thrive in an interactive, team oriented culture, interfacing with discovery and early development functions

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.

How do changes in genome sequence affect biological function and disease? We cannot assay billions of mutations, but evolution has already tested the impact of changing every base in our genomes. Comparative genomics now offers a key to break this ‘evogenetic code’ by exploring which mutations survived evolution and how they correlate with the rest of the genome and on the biology of the organism.

We are looking for a smart, skilled, and highly motivated postdoctoral fellow to lead our exploration of genome evolution by reconstructing ancient genome sequences and modeling mutation patterns and evolutionary constraints. This will have potentially profound implications on understanding human sequence variation (familial and somatic), on understanding protein functions, and on relating genomics to organismal biology.

Our postdoc training encourages exposure to multiple projects, and we also have remarkable opportunities in the integrated analysis of cancer genomes. The Department of Bioinformatics and Computational Biology at Genentech is one of the largest bioinformatics research groups with a remarkable breadth and depth of expertise, a strong team environment, deep links to our research colleagues, and a uniquely strong opportunity to help develop breakthrough new medicines. The Manning lab (http://manninglab.org/) focuses on understanding of biological function and disease through evolutionary genomics analysis.

Summary of Position:

The Compliance & Training associate reports directly to the Manager, Compliance & Training. This individual will work closely with the US Drug Safety staff to support all safety-related activities accountable to US Drug Safety.  In addition, interactions US Medical Affairs Compliance will also occur on an as-needed basis. 

Job Duties/Responsibilities:

• Training of vendors and other 3rd parties to drug safety reporting requirements
• Working with commercial organization to ensure monitoring of Genentech sponsored websites for adverse event reporting
• Oversight of US Drug Safety audit and inspection findings and CAPAs
• Oversight of US Drug Safety local procedures and controlled documents
• Management of US Pharmacovigilance & Safety Data Exchange agreements 
• Management of US Drug Safety global pharmacovigilance commitments
• Monitor IT issues
• Management of special projects
• Track US pharmacovigilance metrics
• Conduct vendor assessments for AE reporting compliance
• Interact, where applicable, with US Medical Affairs Compliance to address safety-related issues or concerns

Provides clinical oversight for a variety of projects, in consultation with his/her Medical Director or Senior Medical Director :

·         Works with a host of internal and external partners and stakeholders in the implementation of clinical trials for assigned drugs/indication

·         Provides scientific input into and/or coordinates the development of specific clinical trial documents for review and discussion with Medical Directors* (e.g., protocols, charters, safety monitoring plans, process documents, etc.) including disease and/or treatment registries

·         Participates in the identification of appropriate external investigators

·         Oversees the clinical trial implementation, ongoing monitoring and evaluation, working closely and regularly with external investigators and Clinical Operations. Active Member in Study Management Team for assigned drugs/indications

·         Develops and cultivates relationships with external partners such as clinical investigators, clinicians, scientists and KOLs, as well as cross-functional partners in Clinical Development, Commercial, Legal and Regulatory.

·         Supports his/her manager in developing clinical components of presentations* for clinical trial investigator meetings

·         In collaboration with his/her manager, coordinates the preparation and reviews data outputs for reporting documents* where appropriate (e.g. clinical study reports, analysis plans, etc.) with the CRO, the Medical Affairs Biostatisticians and his/her Medical Directors

·         Monitors project progress and is expected to proactively identify any issues or challenges and recommend and implement strategies to effectively resolve such once approved with his/her manager

·         Works closely with his/her manager, the publication team and Clinical Operations to complete associated publications, reviews draft publications*.

·         Keeps all partners abreast of projects progress throughout all applicable intervals

·         May also participate/coordinate collaborations with external stakeholders

(e.g. cooperative groups, other companies, etc.) on development and implementation of

approved clinical projects.

·         May coordinate, liaise with internal and external providers for data mining activities

·         Helps his/her manager provide data outputs requested for safety and/or other relevant sections of IND annual reports, if these sections and reports relate to assigned drugs and/or indications*.

·         May interact with NCI or other agency, as appropriate, with supervision from his/her manager

¿ Stays abreast of internal and external developments (scientific, clinical, commercial, competitive, legal, regulatory and like) as such developments may implicate or otherwise impact the implementation of the medical plan of the assigned drug(s)/indication(s). Includes attendance at major scientific conferences, participation in competitive intelligence activities, and review of published literature

Conduct repetitive, predictive, condition based, reactive maintenance and troubleshooting of production equipment within the PTD Operations and Engineering group.  Assist with engineering and evaluation of existing and new equipment and processes.

Responsibilities:
• Responsible for the maintenance and repair of all mechanical process equipment within PTD Operations & Engineering at the South San Francisco facility
• 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.
• Perform troubleshooting of electrical, pneumatic, and mechanical equipment.
• Complete preventive maintenance and assigned paperwork in a timely manner.
• Assist/Manage specialized maintenance and equipment projects as needed.
• Responsible for inputting data to derive performance metrics for management
• Coordinate contractors and work in conjunction with internal business units who perform repairs, modifications, preventive maintenance and installations of mechanical and electrical equipment.
• Provide technical expertise and training to junior staff.
• Assist as a 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 production equipment.
• Ensure/maintain all process equipment and areas in a constant state of inspection readiness; specifically, but not limited to, the following:
o Cleanliness
o Personnel and equipment safety.
o Area maintained in an organized fashion.
• Continuously evaluate all operational Standard Operating Procedures and Preventive Maintenance procedures for accuracy and applicability.  Submit appropriate change requests to supervisor to correct any deficiencies discovered. Create new SOPs and equipment/system related procedures.
• Interact with PTD Operations and Engineering staff members as well as other internal/external customers.
• Follow established safety and environmental guidelines and procedures for all work performed. Immediately report safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. Foster a positive safety culture.
• Respond to emergency call-in when regular scheduled personnel are not available

• 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.

Objectives and Scope of Position:

• Responsible for the preparation of regulatory documents for submission to regulatory authorities within subject area (clinical/safety). This role involves working in close partnership with the medical/scientific content owners in the relevant functions
• Takes accountability for delivering regulatory documents and works effectively and closely with key content owners 
• Applies document and project management expertise
• Contributes to the functional excellence of regulatory documentation (process management) 

Primary Responsibilities and Accountabilities

• Prepare regulatory documents in accordance with applicable regulatory guidelines/Roche standards/SOPs, ensuring high scientific quality & consistency with other documents where appropriate
• Liaise with document contributors to gather information (including Licensing partners where relevant)
• Plan & create timelines for the production and review of documents ensuring alignment with overall project timelines where appropriate
• Review documents for: organisation/clarity/use of English language/grammar/scientific standards/consistency between textual presentations and listings/tabular or graphical displays 
• Manage the review process, including leading/coordinating adjudication of review comments and incorporating review comments
• Participate as a member of key functional/cross functional Team (s) (e.g. Regulatory Area Functional Team, Safety Team etc), ensuring that Teams adequately plan for document deliverables
• Ensure that the document is published in collaboration with Regulatory Operations and that the document is approved by the single accountable signatory

In addition as a Senior Regulatory Documentation Scientist

• Manage the preparation of a suite of regulatory documents e.g. Clinical Dossier, suite of Safety Documents
• Lead Writing Team for preparation of Clinical Dossiers/Safety Reports
• Review documents to ensure adherence to documentation quality standard, regulatory requirements and consistency of messages across all documents for a product/across clinical documents within a dossier
• Prepare specifications for outsourced work (writing/review of documents) and serves as Roche liaison for project purposes
• Plans and creates timelines for the production of assigned documents e.g. Clinical Dossier/Suite of Safety documents. Ensures proper planning and resourcing of all documents assigned to Writing Team including what work or portions of work to be outsourced
• Actively contributes to best practices and continuous improvement within Regulatory Documentation. Represents the group in functional and cross functional initiatives/projects when required