This position may be filled at a Manager, Analytics & Compliance - E4 or a Sr. Manager, Analytics & Compliance level - E5
 
Manager, Analytics & Compliance will support Government Pricing & Reporting (GP) teams and collaborate with key business partners, including other Strategic Pricing & Contract Management (SPCM) teams, Distribution Strategy, Government Affairs, Finance, Legal and Brand Marketing to deliver deep insights and actionable strategic and tactical recommendations that enable Genentech to rapidly and appropriately adapt to evolving U.S. government payer practices, policies, relevant legislation, regulations, trends and other dynamics . Frame and structure approach, research, analyze and synthesize information on the changing/evolving external landscape and internal strategic proposals for implications to government calculations, pricing and other related activities. Perform complex, strategic analysis of Medicaid, Medicare and VA/FSS data, including advanced forecasting, predictive analytics and trending, in order to proactively address current and future scenario planning, solve for “what if” type questions from stakeholders, and determine the impact of regulatory and other relevant changes.

Analytics & Compliance Managers play a leadership role representing Government Pricing & Reporting to cross-functional teams.

Analytics & Compliance Managers also play lead roles supporting GP Calculations and Medicaid Claims processes by advising on impacts of regulatory and other relevant changes to government payer claims and rebates and developing GP methodologies.

Acts as a subject matter expert and trainer on government payers and programs, as these relate to government pricing, contracting, administration, reporting and related matters.  Incumbents in the Manager/Senior Manager Analytics & Compliance role, as all other employees, are fully accountably for compliance with all laws, regulations and policies that govern the conduct of GNE activities.

Technical Skills: Actively Provide Strategic Support and Regulatory Impact Analyses to Relevant Business Partners [relevant business partners – see above description]

• Conducting Analyses & Scope and Structure Key Strategic Driver Business Questions. With some support and guidance from manager, assumes full accountability for asking questions of partner experts to seek deeper understanding of real drivers of decision-making and to identify core business questions. Proactively seek out complex information on changes in laws and regulations. With some support from manager, appropriately scope and structure projects, establishing a framework, key deliverables, and milestones in alignment with key stakeholders. Demonstrate ability to break complex problems down into distinct parts, simplify complexity, and manage uncertainty.
• Deriving Insights. With some support and guidance from manager provide strategic insights and recommendations to relevant partners by linking learnings across projects. Assess appropriate use of secondary research and internal data, leveraging internal expertise and resources as appropriate. Develops appropriate responses with supporting analytical justifications, including recommended changes in complex pricing and contracting strategies. Complement quantitative analyses with government payer and program knowledge to provide qualitative recommendations regarding potential implications or other impacts to Genentech’s business.
• Develop and Maintain Analysis Tools. Conducts quantitative analysis of government payer programs’ data to identify and provide data-driven insights and support government reserves forecasting; includes forecasting, trending and data mining. Maintain relevant data and information into respective departmental/company systems and databases to ensure current, accurate and robust analytics and reporting. Participates in the development, education, communication, implementation and ongoing maintenance of GP analytical methodologies and models, data and reporting templates.
• Presenting Results. Presents objective insights from analyses to relevant partners up to and including CLC. Produces and disseminates routine and ad hoc reporting to ensure GP and other cross-functional partners and stakeholders are kept fully abreast of key information relating to assigned government payers and programs. Creates and implements standard and ad hoc reports.
• Level of Expertise. Responsible for updating relevant government program methodologies and keeping these current at all times. Is knowledgeable in a variety of structured problem solving frameworks, market research methodologies, and excel forecasting techniques, and can apply them across business questions. Develops relationships and collaborates with relevant cross-functional partners to deliver respective subject matter expertise (see above j...

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.

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

Reports to: Division Manager, Franchise Sales

Example Duties andResponsibilities:

*Responsible for meeting or exceeding assigned sales targets

*Develops robust territory business plans

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

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

*Monitors operating costs and compliance with territorybudget

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

*Business travel, by air or car, is regularly required 

Level:
Automation Engineer I (E2)

Genentech's US Biologics Pharma Technical Development organization is looking for an Engineer I to work in our Process Development Engineering group (PDE).  PDE's role is to provide innovative engineering services to the cell culture and purification pilot plants and labs.  PDE also evaluates new automation, robotics, and process sensor solutions for Drug Substance processing.

The Automation Engineer will be expected to support the users and systems in the large scale cell culture pilot plant.  This role will require design, specification, implementation and maintenance of bioreactor control systems for both mammalian and microbial processes.  Key roles and responsibilities include:

-  Identification, evaluation and implementation of new technologies to improve the efficiency and safety of control systems at Genentech.

-  Maintenance and troubleshooting of hardware and software on the process control systems in the Process R&D Labs and pilot plants.

-  Design, implementation and support of laboratory automation systems.

-  Leading and supporting small project teams which design develop and integrate automation systems in the Process R&D laboratory and pilot plants.

-  Scope of work definition and supervision of contract labor for small and medium projects under the direction of a senior engineer.

-  Collaboration with Corporate Engineering, Manufacturing Science and Technology (MSAT) and other business partner groups on technology transfers and information exchanges.

-  Author and maintain system support and specification documentation.

-  Author technical reports and/or presentations.

-  24/7 on-call support is required for this position.

Medical Communications Scientist is able tocommunicate relevant, timely, accurate, and balanced clinical information onGenentech's products, positively influencing their safe and effective use.

DESCRIPTION:

The Medical Communications Scientist is able tocommunicate relevant, timely, accurate, and balanced clinical information onGenentech's products, positively influencing their safe and effective use. Ableto evaluate medical literature as well as write, review, edit, and approvemedical content to ensure appropriate clinical context and accuracy. Providesmedical responses through various communication channels (response documents,web-based media, scientific meetings, etc.). Is also able to provide trainingrelevant to Genentech's product portfolio. Has a basic understanding oflegal/regulatory topics adequate to describe the basis of Medical Affairspolicies and procedures, and applies this knowledge to the review ofpromotional materials and Medical Affairs documents.  The Medical Communications Scientist is able to assist in the development andimplementation of Medical Communication policies and procedures, establish andsupervise the work flow for delegated projects, and assess incoming requestinformation to determine required action and triage based on internal policiesand procedures. Can convey and acquire medical information as well ascommunicate and work effectively with members of the Medical Communicationsstaff and customers which include but are not limited to: Sales, Marketing,Managed Care, Clinical Development, Product Safety, Regulatory, Legal, andCorporate Partners.

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

Reports to: Division Manager, Franchise Sales

Example Duties andResponsibilities:

*Responsible for meeting or exceeding assigned sales targets

*Develops robust territory business plans

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

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

*Monitors operating costs and compliance with territorybudget

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

*Business travel, by air or car, is regularly required 

We are seeking a collaborative individual to contribute to a team that is responsible for generating recombinant proteins by transient transfection of mammalian cells. The candidate’s primary responsibility will be high throughput transient protein production to support research and development projects. The tasks will include those associated with coordinating and performing cell culture operations (i.e. set up, inoculate, monitor, harvest and clean fermentors) as well as experiment data recording, collection and analysis. He /she will display a strong focus on collaboration, attention to detail, proficiency with multi-tasking and analytical ability. The secondary responsibility of this candidate is to optimize our transient transfection process. This includes identifying and solving technical issues, performing process development experiments, and evaluating and implementing new technology/instrumentation based on scientific literature and industry trends.  The right candidate will have experience with supervisory or management responsibilities.

Group Strategy Manager 

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

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

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

Genentech is currently searching for a Senior Director, Department of Immunology. The incumbent in this role will be responsible for all target and therapeutic discovery activities for autoimmune and inflammatory diseases in the Genentech Research and Early Discovery organization. The incumbent also will oversee the interactions between the Immunology Department and all diagnostic, clinical, commercial, and business development activities for these diseases.

This is a 2 year TERM position:

The primary responsibility of this position will be to report to the
operations Sr. Manager in charge of a global group that executes
testing (cell based and PCR based platforms) for adventitious agents,
i.e., virus, mycoplasma in CHO-derived products following established
procedures and in compliance with cGMP’s.  The position will require
work in the laboratory executing the test methods for both routine lot
release and validation of the methods on a product specific bases.
The analyst in this position will be expected to execute other QC
laboratory related activities with other team members like sampling
handling, equipment maintenance and review of QC batch test records
and certificates of analysis.  The position will also be expected to
author study reports and draft protocols for approval on validation
and/or investigational studies, review and/or author discrepancy
protocols and assessments.  Opportunities for participation as a
trainer on various topics related the detection methods utilized in
the lab, regulations that govern the use of those methods and topics
about Quality and compliance will also be available.

The Senior Corporate or Corporate Counsel will work as part of the Healthcare Law Group within Genentech's Legal department. 

The position will initially focus on counseling Genentech’s commercial sales and marketing clients, with opportunities to advise medical affairs and development across the lifecycle of products. The position may require counseling medical affairs and development teams with human medicines and companion diagnostics in all phases of development.  

 JOB/POSITION SCOPE:  

•  Manage outside counsel on complex or more advanced matters or projects 
•   Responsible for one or more key client relationships typically at Director level or   higher 
•  May be single point of contact or represent practice group or functional area on significant projects or committees 
• Provide advice, education, training and legal direction on FDA labeling and promotional matters, healthcare fraud and abuse laws, product liability, antitrust, privacy and other laws impacting the commercialization of biotech products;
•  Assist in structuring tactics and related contracts in compliance with applicable law;   
•  Serve as lead legal counsel for global development programs and medical affairs initiatives
• Negotiate agreements with cooperative groups, government entities, study sites, and other parties involved in global studies; and
• Draft and interpret  company policies, and educating clients and colleagues about enforcement trends and discrete legal issues.   
• Act as a subject matter expert on all matters relating to healthcare law and related business operations 
•  Act as a standing or ad hoc member of business or leadership teams and provides legal counsel and expertise into business decisions 
•  Develop an in-depth understanding of assigned departments and functions in terms of their, organizational structure, processes, business goals, strategies and challenges, etc. 
•  Provide  legal advice in matters relating to healthcare law, including healthcare fraud and abuse, FDA regulations on clinical trial conduct, labeling, advertising and pharmacovigilance, product liability, pricing and reimbursement, antitrust, privacy, and other matters relevant to the development, manufacture and commercialization of products 
• Provide  input and legal advice on business strategy, tactical plan development and implementation, and other business issues; including legal assessments, solutions-oriented risk mitigation strategies, messaging, and interactions with healthcare professionals, patients and other external parties 
•  Participate  in, lead  and/or present  to various Company committees or other advisory, project or work teams and provides healthcare and business law expertise and guidance 
•  Review  business materials (clinical trials, brand plans, promotions, medical plans, publications, training documents, etc.) requiring legal input and advises internal clients, partners and stakeholders on compliant strategies, plans and tactics 
•  Provide  transactional support to assigned internal clients. May include drafting, negotiating, and/or reviewing contracts, creating, updating and training on contract templates, negotiating language, developing associated legal/contractual documentation and/or policies & procedures, and counseling on contract disputes   
•  Interact and communicate with Roche affiliates and global partners, as appropriate, to apprise them of relevant Company policies, procedures, practices, important business issues, etc. and share best practices or coordinate legal support 

 PEOPLE MANAGEMENT: 

• May manage administrative personnel 
• Where applicable, lead recruitment, hiring and on-boarding for direct report positions 
• Accountable for direct reports' work to ensure on-time, on-target and within-budget results 
• Ensure direct report(s) are appropriately trained, developed and coached 
• Responsible for performance management of direct report(s)

DEVELOP & MAINTAIN  KNOWLEDGE 

• Stay abreast of evolving healthcare and related legislation and regulations and the enforcement landscape. Advises the Company and colleagues of potential implications to current or future strategies and operations and assures ongoing compliance 
• Develop and implements training to educate internal clients, partners and stakeholders on key policies, procedures, practices and requirements for healthcare and related legal c...

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

Main Responsibilities and Accountabilities:

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

• Is a standing member of the site and/or regional Regulatory Technology Leadership Team
• May lead the site or regional Regulatory Technology management team. Drives best practices and operational excellence within the department and cross-functionally and ensures timely communication and information dissemination across the department and beyond
• As needed, ensures appropriate appointment of staff members as ad hoc members in Regulatory Affairs Functional Teams (RAFT); driving and ensuring effective and efficient support for cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution
• As assigned, self and staff may act as standing or ad hoc members of other teams for special or ongoing initiatives and projects

• Develops and manages annual and/or longer-range departmental budgets and resource plans
• Tracks departmental expense budgets to ensure compliance with agreed parameters
• Where applicable, self and team may participate in the negotiation with and commissioning of external vendor partners to support the work of Regulatory Technology
• Accountable for appropriate resourcing decisions for assigned Regulatory Technology function and staff
• Cascades strategic and other relevant goals and objectives as well as budget and other resources to direct reports
• Leads recruitment, hiring and on-boarding for his/her staff member positions. May include, as needed, short-term contract personnel
• Plays a lead role in creating and maintaining a positive work environment by encouraging mutual respect, innovation and accountability at all levels (global, site, functional, projects/programs)
• Ensures that performance of assigned Regulatory Technology management and staff is proactively managed and that management and staff are appropriately trained, developed and coached to maximize their contribution and ensure compliance with Roche and regulatory guidelines and standards. Accountable to ensure assigned management and staff consistently complete their deliverables and other responsibilities on-time, on-target and within-budget
• Conducts ongoing performance management and completes the required steps of Roche’s performance management process and cycle. Includes individual development plans/career discussions and actively contributing to performance calibration, talent management and succession planning processes
• Actively participates in management and skill development programs for continued professional development
• Leads routine and ad hoc meetings with assigned Regulatory Technology management and staff
• Identifies, recommends, assigns or otherwise undertakes special projects that further the success and effectiveness of Regulatory Technology and/or PDR overall
• As needed or otherwise appropriate, acts as a substitute for his/her manager in various meetings, communications or other forums
• Consistently complies...

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

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

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

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

The job responsibility within the ADQC--Biological Technologies Testing Group is to perform cell-based and immunochemical/biological assays in support of process development, stability, and lot release testing with established procedures in a GMP environment.  Role includes reviewing assay packets and releasing assay data as well as prepare assay reagents, generate computer results, monitor assay quality, use of LIMS, maintain the lab via Lean tools such as 5S and EHS safety practices.  Expectations include lab maintenance and project support/equipment qualification/computer systems/document management as needed.