Position

Pharmacovigilance Programmer Analyst

Job Summary/Purpose:

Experienced Oracleprogrammer with good knowledge of Drug Safety databases.

• Assumes responsibility for the analysis of data from the Drug Safety Database (ARISg DataMart).
• Develops, tests, documents, maintains and validates programs written in SQL, PL/SQL and SAS.

Primary Job responsibilities:

The positionis within the Data Management Group (DMG). DMG is responsible for dataretrievals from the Drug Safety database. These retrievals are performed on adatabase named "ARISg DataMart", a databases that gets dailyincremental uploads from the ARISg transactional system. The DataMart isdesigned and optimized for data retrieval.

The maincustomers of DMG are the members of safety Science located in Basel,Switzerland, and San Francisco, CA. DMG performs data retrievals for ad-hocquery requests, aggregate reports and for signal detection. Currently all DMGmembers are located in Basel, Switzerland. The position is created to supportSafety Science on site in San Francisco.

Thefunctional requirements in detail are the following:

• Interactswith internal or external customers to clearly define the search criteriarelating to requests; and to aid in the selection of the appropriate dataanalysis strategy and adequate presentation of results.
• Checksresults of database retrievals for consistency and plausibility. Initiatesappropriate actions in case data inconsistencies are detected.
• Performs thestatistical analysis and presents data in appropriate format i.e., reports,line listings, tabulations or graphs through using a variety of tools like SQL,SAS, Excel.
• Ensurestimely and correct delivery of search results.
• Responsiblefor the documentation of the search strategy and the results (electronically oras hard copies). Ensures search strategies and results of searches are filedand archived.
• Assists inout-of-normal-office-hours ad hoc/special database searches in the event ofurgent enquiries or audits by regulatory authorities.
• Assumesresponsibility for signing validation documentation.
• Ensures anyissues relating to database searches are highlighted to the Head of PDS DataManagement Group.

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

The Sr. Finance Manager plays a pivotal role providing financial support for Global Biologics Technical Operations (PTB).  The Biologics Operations manufactures over 70% of worldwide Pharma revenue and is the primary supplier of clinical production.

This position reports to the Head of Finance – FMTB Financial Planning & Analysis and Accounting and supports the financial planning and analysis of 11 manufacturing sites in 9 locations and $2.5B of spending. 

This is a high-profile, global role that interfaces with senior management and cross-functional finance teams such as Supply Chain, Quality and Operations.  

Specific Responsibilities:

• Support forecast, budget and long range planning process for PTB, coordinating with finance teams across US, Singapore and Europe.  Produce executive updates and analyses.
• Provide support to local Genentech manufacturing finance functions in planning activities, such as financial systems interface (TM1) and process management.
• Partner with global finance teams to explain underlying business drivers on variances and alert management on risks and opportunities. 
• Consolidate, analyze and communicate financial performance for global Biologics.
• Collaborate with financial systems team to improve financial models, processes and analyses.
• Business partner with several leaders on forecasting and reporting their cost center budgets. 

Data Management Manager / Sr. Manager

Data Management Manager / Sr. Managers act as subject matter experts and lead contacts for Commercial Operations’ Customer Master Data. The Master Data Management function and team are responsible for development and management of all Commercial Operations’ Customer Master Data operations and projects, including analyzing and matching master data with customer data, reconciling and validating data, systems or database upgrades and ongoing management, attending to ad hoc data requests, and leading and/or participating in special data projects that impact Commercial Operations’ Customer Master Data. Like other Data Management teams, Master Data Management works closely with a host of internal partners, including Genentech’s Commercial Operations Informatics (gCOI), as well as external data or IT vendors/consultants. Data Management Manager / Sr. Managers are typically assigned the largest or most complex projects or other operations to support and they may also people management responsibilities for one or more direct reports. Incumbents in the Data Management Manager / Sr. Manager role, as all other employees, are fully accountable for compliance with all laws, regulations and policies that govern the conduct of GNE activities. As a manager of others, the Data Management Manager / Sr. Manager is not only accountable for his/her own compliance, but also for the compliance of all individuals in his/her team. As such, leads the way and leads by example by demonstrating full knowledge and commitment to all applicable policies. Monitors adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required.

Incumbents in the Data Management Manager / Sr. Manager role are generally expected to:

• Act as lead subject matter expert for Commercial Operations' Master Data Management operations and projects. Including leading and/or otherwise supporting the largest and/or most complex projects or other operations: 

• Identifying new business rules to support best-in-class customer master data
• Expertly leading data analysis, extraction, matching, reconciliation and validation activities with the highest possible levels of accuracy and timeliness
• Consistently complying with all Genentech IT protocols, procedures, standards and other relevant business requirements
• Expertly fulfilling other ad hoc requests and leading special data projects, which includes upgrading and launching new systems or upgrades
• At all times, ensuring all work is completed on-time and on-target to fully meet or exceed expectations, goals and targets
• Developing and maintaining excellent working relationships with customers, partners and other stakeholders; providing the highest quality customer service and following established departmental protocols, policies and procedures

• Act, and is accountable for others in his/her team acting, in complete & total compliance with all laws, regulations and policies
• Manage the overall relationship with master data vendors
• Utilize only approved resources and messages to meet goals and targets
• Where assigned, recruit, hire, and develop direct reports, as well as oversee their work to ensure assigned goals, objectives and targets will be met or exceeded
• Effectively and efficiently train end-users and/or other customers, partners or stakeholders on Commercial Operations’ Customer Master Data operations, content, usage, applications and the like
• Support his/her manager and other team members in training and mentoring less experienced analysts
• Participate, as and when needed or otherwise appropriate, in cross-functional or other project teams; helping the overall business of Genentech to continuously evolve, improve and excel

Responsible for producinginnovative biotherapeutic medicine by interfacing with highly automatedproduction systems and controls in cGMP manufacturing environment, and maintainareas in high state of inspection preparedness. Operates production equipment for cell culture or purification that mayinclude culture growth, process monitoring, sampling, harvesting, purification,formulation, freeze thaw and transfer.  Performsmedia/buffer solution preparation operations. Maintains records and clean room environment to comply with regulatoryrequirements utilizing current Good Manufacturing Practices (cGMP) and StandardOperating Procedures (SOP).  Responsible for being proficient in two or morefunctional areas and applies expert knowledge of mechanical, scientificprinciples, processes and biopharmaceutical processing equipment.

• Provide coaching and training on best practices and compliance toSOPs.
• Prepare solutions for the production process.
• Participatein continuous operational improvement.
• Providereports to management summarizing goal unit attainment.
• Work with coworkers and supervisor to effectivelytroubleshoot equipment and process issues.
• Understandsthe theory, concepts, and regulations behind biopharm technology andprocesses. 
• Astrong knowledge of at least one manufacturing department with an understandingof process impact of other areas.
• Anticipatespotential problems and takes preventative action.
• Requiresjudgment to know when it is necessary to consult with supervisor and/or supportgroups. 
• Understandshow own actions impact others and uses this information in decision-making.
• Operate systems that clean and sterilizetanks and filtration systems. 
• Prepare solutions for the production process.
• Review documentation and check allcalculations (e.g. tickets, labels, equipment reading).
• Trouble shoot equipment and processproblems.
• Comply with safety requirements, cGMP,SOP and manufacturing documentation.
• Use of automation to perform production operations.
• Provide support to Manufacturing to meet production demands.
• Operate automated systems for equipment operation.
• Assemble and prepare equipment for production.
• Exhibit detail oriented documentation skills.
• Communicate effectively and ability to work in a teamenvironment.
• Exhibit professional interpersonal skills. 
• Work with coworkers and supervisor to effectivelytroubleshoot equipment and process issues.
• All employees with jobs that require access to theWarehouse must be able to pass the Transportation Security Administration (TSA)Security Threat Assessment (STA).
• Follows established safety and environmentalguidelines and procedures for all work performed.  Immediately reports safety and environmentalincidents including injuries, illnesses, near misses, and safetysuggestions.  Fosters a positive safetyculture in which no one gets hurt.
• Operate fermenters, centrifuges, otherharvest systems and protein purifications units.
• Operate and clean fixed tank and filtration systems.
• Operate large scale column chromatography systems.
• Operate small-scale cell culture areas and systems by operatingcleaning, set up, and maintaining 20L batch reefed fermenters; inoculating andmaintaining spinner seed cultures using aseptic techniques, maintaining cellbanks; and performing general seed lab operations.
• Perform CIP and SIP. 

Project Manager – IT (Genentech – South San Francisco)

The MCCO Solutions team in IT Americas is looking for a motivated Project Manager to lead the delivery of technology projects in support of US Commercial Operations. The IT Project Manager is accountable for the successful delivery of technical solutions through effective planning and execution throughout all phases of the project management methodology. The PM will be responsible for managing assigned resources, effectively tracking budgets and financial forecasts, creating and tracking detailed project plans, leading and facilitating project meetings as well as proactively controlling project scope, risks and issues. This PM position will be accountable for projects in the MCCO Solutions group for the Commercial Customer Operations portfolio.

Duties:

* Define, plan, and lead the execution of technical implementation projects, while balancing the competing demands of scope, time, cost, quality, resources, and risk

* Ensure project objectives/requirements are clear and agreed to by all stakeholders

* Manage relationships with various technology vendors/partners and business stakeholders to achieve project objectives

* Establish and maintain effective communication for assigned projects and with dependent projects

* Ensure successful and timely completion of deliverables

* Track progress against baseline schedule

* Plan, baseline and control costs to ensure projects are completed within approved budget

* Suggest process improvements where appropriate to improve operational efficiencies

* Conduct risk management planning, identification, analysis and monitoring on projects

* Other duties as assigned

Supervisor

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

The candidate will be a member of the Analytical Chemistry group in the Method Management and Technology (MMTech) Function within Genentech’s Corporate Quality Organization.  MMTech is the scientific and technical Center of Excellence for commercial quality control methods, specifications/control systems and reference standard and provides support to the Roche/Genentech Global Quality Control Network for the commercial biotech product portfolio. We are looking for an experienced Scientist to play an integral part in providing and supporting analytical chemistry methods (e.g. HPLC, CE) used for quality control purposes.

MAIN PURPOSE OF THE POSITION

• Responsible for method troubleshooting and optimization in support of life-cycle management of methods for Roche/Genentech commercial biotech products
• Develop and execute experiments for the development, validation, implementation of QC test methods for commercial biologic products following cGMP regulations, regulatory guidelines as well as local and global quality standards.
• Support regulatory submission and inspections: through authorship of CMC subsections, responses to questions and direct interactions

JOB DUTIES/RESPONSIBILITIES

• Serve as analytical technical lead/representative (biotech products) on cross-functional and multi-site project teams.
• Ensure on-time delivery of controlled documents, reports and method packages to support project timelines.
• Apply technical knowledge, scientific experience and expert judgment to address a broad range of difficult problems.
• Troubleshoot and direct the resolution of QC method issues by fostering effective interdepartmental and cross-functional partnerships.
• Serve as a technical subject matter expert (SME) in support of departmental functions.
• Perform assigned tasks and work to achieve company goals and department objectives.
• Train personnel and internal customers on relevant business processes.
• Support the development and administration of Quality Control and laboratory training materials.

Sr. Strategy Manager

The Sr. Strategy Manager, Strategic Pricing & Contracting develops pricing and contract strategies for the assigned segments that optimize the value of Genentech’s portfolio, which includes leading cross-functional segment strategy development teams, building effective relationships with account core teams, internal teams across MCCO (Managed Care & Customer Operations), scenario analysis/modeling for overall financial and legal viability, and ongoing pricing and contract performance assessment/analysis.

This opening would be primarily focused on leading launch preparations for octreolin, a recently in-licensed compound for the treatment of acromegaly. Acromegaly is a disease affecting 20,000 people in the US. This is a long-term condition in which there is too much growth hormone present resulting in body tissues enlarging over time, ultimately leading to various co-morbidities and a shorter lifespan. We are excited about this opportunity for Genentech as we feel that octreolin could represent a significant advance for patients with this devastating condition. The potential launch timing is Q1, 2015.

This supervisor role would oversee the Growth Franchise (Nutropin and Octreolin) and will have one or more direct reports and will also share some of the other departmental management activities with their manager, e.g., reviewing the work of other managers, developing training/development programs and initiatives for team members, preparing and delivering senior management presentations on strategic or complex issues, leading strategic projects, etc. Given the nature of this group’s work, most management and staff in this department have considerable responsibilities for regular communications, interactions, coordination and development with partners in the broader Roche organization, and communicating with, influencing, and securing approval from senior management.

• Typically manages pricing activities and contract strategy performance analysis for more complex, high-volume or high strategic value products
  • Participates in various Genentech business planning meetings and processes
• Regularly leads strategic pricing & contracting analysis and assessment for the assigned segments, franchises and products across all stages of the lifecycle
• Acts as segment subject matter expert for assigned account segments
• Works closely with Account core teams to devise appropriate strategy for decision-making, terms and negotiation.  Executes all needed analytics to influence MCCO Governance or related field leadership teams on winning strategies
• Stays abreast of macro trends in the healthcare environment that could potentially impact pricing and contracting opportunities and/or risks
• Conducts or commissions market research and competitive analysis working with other internal or external partners as necessary
• Develops detailed quantitative and qualitative analyses and modeling of pricing and contracting strategies and recommendations
• Synthesizes market and business analytics in presentations and communications
•  Works with brand pricing and contracting strategy leads to align brand or overall segment strategy with account-based needs
•  Tracks and communicates all relevant pricing and contracting trends and issues in assigned segments to internal partners/stakeholders
•  Prepares internal reports and presentations and reviews with key internal partners/stakeholders; has frequent presentations to senior management
•  Identifies and recommends metrics to assess pricing and contracting strategy effectiveness for all assigned segments
•  Tracks and monitors account performance, including post-hoc analysis of account level strategy and implementation results
•  Works closely and collaboratively with a host of internal partners/stakeholders including, but not limited to operations departments to understand operational considerations and constraints related to strategies and representing this input to the core teams
•  Recommends on contract group clustering to ensure appropriate consistencies as well as provide maximum leverage, efficiencies, and effectiveness
•  May support manager in building pricing and contracting models and other tools for department-wide analysis and assessment
• Translates research, analysis and modeling into documented pricing and contracting strategies.  Works with manager to ensure integrated cross-segment consistencies and efficiencies
• Evaluates immediate-, medium- and longer-range business and financial impacts of pricing and contracting strategies
• Identifies and supports others in planning for operational and tactical requirements to support pricing and contracting strategies for existing, new, in-line and/or pipeline stage products
• Partic...

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...

Responsibilities:  A postdoctoral position is available to study oncogenic pathways in breast cancer.  Strong molecular and cellular biology skills are required. The successful candidate should have familiarity with mutagenesis, RNAi, signal transduction, and protein characterization. Candidates with a strong background in protein structure and function will also be considered. A practical working knowledge of bioinformatics analysis would be desirable.  The successful candidate will be required to work in a highly collaborative and multi-disciplinary environment. See recent publications: Cancer Cell 20:472 (2011); Cancer Cell 15:429 (2009); Cancer Res 68:9280 (2008).

Provide statistical and strategic support related to clinical development plans, study designs, planning and execution of exploratory biomarker analysis, and incorporation of biomarker objectives in clinical development plans.

Major Responsibilities and Accountabilities:

• As part of a clinical development team, collaborates in the preparation and review of protocol writing, CRF design and monitoring of ongoing clinical trials.
• Provides technical and strategic support into clinical development plans
• For assigned clinical development project(s), provides statistically sound clinical trials design, including clinical pharmacology trials and data analysis input to meet project objectives.
• Supports teams in the development and review of regulatory submissions such as clinical protocols, INDs and pre-meeting packages.
• Provides strategic and analytical support for exploratory project activities such as biomarkers and PK/PD analysis
• Develops statistical analysis plans, including biomarker analysis plans, prepares data displays and as necessary develops statistical programs to perform exploratory analyses.
• Authors the clinical study report; with help from senior statistical staff, leads team members to complete the report.
• Provides advice and training on the use of statistical methods and software packages to the biomarker scientists
• Collaborates with scientists in support of external publications.
• Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review, workshop attendance, etc.

Act as the main point of contact between Solution Owners, Project Managers and the Operations Support team in the release or implementation of new services, applications or products into production. Ensures smooth transition of new Operational Services and provides implementation support for the Regions

• Ensures tools, processes and procedures are in place to enable the Regions to support new services, applications and products
• Coordinates with the AE&O Support Processes & Continuous Improvement team and the Regional Account Managers on the release and design of new services, applications and products into production 
• Develops methods to track and monitor the Service Health and provide initial reporting
• Acts as the main point of reference and is consulted in Operational AE&O IT projects that impact the tools, processes and technologies used in the Operational Teams in the support of AE&O provided services
• Develops Training material for new Services in collaboration with the solution owner and coordinates the Trainings with the Regional Account Managers
• Assists the Site Implementation Team during the integration of new sites or acquisitions to ensure Processes, Training and Regional/Local Support is in place.   
• Coordinates with the Support Processes & Continuous Improvement Team, the AE&O operational Teams and the Regional Account Managers to ensure tool and Process availability for a upgrade to an existing service, new service release or implementation 
• Ensures and coordinates knowledge base updates with any required information to support a release or implementation
• Ensures Training material availability on new processes and procedures and coordinates Trainings in cooperation with the Regional Account Managers
• Reviews project plans with the Solution Owner or Project Manager for transition planning and provide feedback to ensure a smooth release or implementation.
• Provides reports and monitoring on the impact of releases and implementations on the AE&O operational Teams and the Regional and Local support teams and drives improvements until normal operations are achieved
• 
  
• Works with Solution Owners and Project Managers to ensure that requirements of the Operational Teams and the Regional/Local Support teams are represented and understood
• Ensures efficient processes for Operational and Supporting teams and establish an aligned incident escalation chain to reduce escalations. 
• Push automation opportunities for request and change management, reduce escalation of incidents by enforcing Knowledge management usage and validation of KM data.
• Establish early reporting and Service Health metrics with trending information on incidents, requests and changes. 

Primary Purpose of Job (Job Summary)

> Lead and execute on Organizational Communication and Change Management activities in support of projects for the GPP projects.

Principal Roles & Responsibilities/ Accountabilities – Major functions of the position

Management Roles & Responsibilities

* Responsible for the assigned tasks on GPP projects globally

Functional Roles & Responsibilities  

* Lead organizational communication and change management related activities across key GPP projects.

* Assess the needs of change management for specific projects and provide recommendations to address the changes and ensure realization of the project scope and objectives

* Align with and utilize Business Process Excellence (BPE) resources and methodology throughout the project life cycle(s). Ensure that objectives and critical success factors are identified, met and measured.  Strive to develop a well-rounded BPE skill set. 

* Identify risks, anticipated points of resistance and potential lack of sponsorship and develop plans to effectively mitigate these 

* Develop actionable change management plans, including risk assessments, stakeholder engagement, communication, and training plans for any assigned projects

* Coordinate with team members, sponsors, Business process managers, local end users/customers, and stakeholders to ensure alignment with project  and GPP vision, goals, and objectives and understand the needs of customers and stakeholders 

* Work with Team members to integrate change management and communication activities into the overall project plan to secure effective and lasting adoption.

* Facilitate meetings, workshops and other events where communication and change management are required. 

* Actively participate and facilitate at all team meetings as a full member of the assigned project team, 

* In partnership with the Business Process Owner (BPO)/Sub Process Owner ensure an effective business review process with all relevant input about prioritization, impacts, cost/benefits, vision and objectives associated with project deliverables and change management/communication.

* Coordinate with Technical teams and business end users across the project lifecycle in all areas associated with communication and change management

* Work individually and in groups with project team members and stakeholders as needed

* Engage and coordinate with training managers and planners. Make sure the Training Materials and information sharing tools consistently reflect updates with regards to change management and communication (e.g. Roche Wiki, Procurement Manual) 

* Build strong collaborative networks with key stakeholders and ensure communication is concise, consistent and compelling

* Ensure alignment of change management approach and stakeholder outreach across related Infrastructure projects, optimizing stakeholder involvement.

* Ensure compliance with global business process guidelines, policies, and governance.  

* Drive for continuous improvement and scalable and sustainable solutions to meet global needs

* Engage as a fully vested member of the GPP team and support all goals and objectives of GPP

Membership in Decision Bodies and Major Internal Working Groups or Alliances

Decision body, working group

Chair

Member

Guest/ affiliated

Global Pharma Procurement Leadership Team

Procurement Services Leadership Team

Procurement Services BPE Leadership Team 

Procurement Services Infrastructure Leadership Team

GPP Communication, Procurement Academy, Change Management Teams

Project Teams/Related Initiative Teams

Working Relationships

Key internal interfaces:

* Site/Function Procurement Heads

* PMs/ Local Systems Managers / Site Champions/BPm

* Business Process Excellence Leaders/Teams

* Finance and Audit

* Informatics Teams (PGSD / PGST / FPSE)

* Business Process Owner / Sub Process Owner 

* End Users/Impacted parties and stakeholders

* Training Resources/Coordinators and Procurement Academy Leaders

* Project sponsors and steering committee members

* 

Key external contacts:

* External resources for training and coaching as required

S3

Who we are

At the RocheGroup, about 80,000 people across 150 countries are pushing back the frontiersof healthcare. Working together, we've become one of the world's leadingresearch-focused healthcare groups. A member of the Roche Group, Genentech hasbeen at the forefront of the biotechnology industry for more than 30 years, usinghuman genetic information to develop novel medicines for serious andlife-threatening diseases. The headquarters for Roche pharmaceutical operationsin the United States, Genentech has multiple therapies on the market for cancerand other serious illnesses. Please take this opportunity to learn aboutGenentech, where we believe that our employees are our most important asset andare dedicated to remaining a great place to work.

The Position

The successful candidate will participate in cross-functionalproject teams discovering antibodies with high therapeutic potential to addressmajor unmet medical needs across different therapeutic areas.  This hire will lead a group discoveringantibodies from immunized sources. Research by this group will included enhancing understanding andoptimizing the immune response in immunized mice plus isolation and culturingof antigen-specific B cells.  Thisindividual is expected to collaborate closely with colleagues in other antibodydiscovery groups and other departments.

The PD Clinical Operations / Biometrics / Clinical Science Informatics team (part of FPPO) is looking for a senior Business System Analyst (BSA), with in depth Business analysis experience in the Pharma/Biotech industry and the ability to strategize, recommend and implement solutions with an end-to-end process filter that will meet the short and long term needs of Clinical Operations.

The senior BSA is responsible for exploring, scoping, planning and supporting the successful implementation of solutions by providing business analysis, best practice research, detailed requirements definition and user acceptance facilitation.

We are looking for an individual with strong customer focus, experience in working in global, multi-cultural environments, with a structured working approach and excellent analytical and communication skills. 

FURTHER RESPONSIBILITIES / DUTIES ARE:

• Participate and conduct strategic / exploratory workshops to identify / plan / execute innovation experiments and to contribute to robust roadmaps supporting the business strategy. Example: resource may participate to the Trial2Patients initiative 
• Collaborate with business and informatics stakeholders to lead business case development for new initiatives as well as business case tracking for completed initiatives.
• Plan early stage project efforts; specifically, requirements gathering, assessment and scoping, and project initiation and funding.
• Plan and facilitate workshops and end-user working sessions intended to surface requirements and validate designs.
• Take active role in preparing initiatives for portfolio committee and approvals at appropriate project milestones.  
• Collaborate with other BSMs / BSAs across functions and regions to identify and address business problems and opportunities, evaluate alternative informatics technologies and research industry best practices and emerging trends.
• Collaborate with Project Managers, Architects, Engineers, Developers, and Designers on scope, solutions, constraints, and risks
• Analyze document current and future business process models
• Take responsibility in ensuring the solution meets the customer needs. Support operational services teams in ensuring continued business value realization and business adoption.
• Collaborate with BSMs / BSAs within function and across functions to continuously harmonize and further develop skills and working practices specific to the BSM/BSA community within the organization 

Main Purpose of the Position

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

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

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

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

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

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

Job Duties/Responsibilities 

Contract Manufacturing Lifecycle Management

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

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

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

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

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

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

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

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

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

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

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

1.1. Business

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

* Lead project team meetings and technical operations meetings.

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

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

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

1.2. Operations

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

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

The ERP Portfolio and Demand Management Coordinator position provides non-technical support primarily to the North American based ERP (Enterprise Resource Planning) team, within the Shared Platforms and Applications area of Pharma Informatics. The global ERP team consists of approximately 180 team members, 50 of which are based in our SSF office. The ERP team mainly supports the business application areas of SAP, Business Warehouse and ARIBA.

This SSF-based position is within the ERP Portfolio and Demand Management team. The ERP Portfolio and Demand Management team is responsible for many important cross-functional topics, such as financial management, demand planning and communication, supporting and advising project managers, process implementation and compliance, audit co-ordination and tracking, metrics and reporting, as well as adhoc management support requests. We support the various managers, project managers and application teams to ensure consistency and efficiency across the ERP Department. 

As part of this small team, you will have a varied and challenging role, working on cross-functional topics while interacting with team members in Basel as well as colleagues other functions (e.g. Finance, Procurement, HR).

You will have the following key responsibilities:

• Support the required financial processes, including the coordination of the budget and monthly outlook events and monitor the budget versus actual spend. Proactively support and advise the SSF based activity owners and project managers on financial topics
• Provide the required financial reports and updates, accurate and timely organizational information and recommendations to ensure the ERP department stays within the given budget
• Support the ERP Team, being the point of contact and advisor for the North American based ERP team with day to day business processes to ensure efficiency and accurate information flow (e.g. purchase order creation and processing, payment of invoices, checking accuracy of accruals, etc.). Advise team members in order to resolve issues in a timely way.
• Manage key relationships and liaise with other departments as required, e.g. Finance, Procurement, HR.
• Support the ERP Team with the needed tools and processes to manage the ERP portfolio of work, which will enable the ERP department to meet the needs of their customers.
• Participate in or lead small projects/initiatives as needed to ensure implementation of common process and tools (e.g. Resource management, Customer satisfaction surveys) and provide ongoing support to the ERP Department
• Assist the Portfolio and Demand Management team establish and report on metrics required by the ERP Solution Owners
• Support and assist with the ongoing improvement of Collaboration tools, such as Touchpoint.