• Acts as lead of market planning team and primary contact for Market Planning projects and customers
• Supports strategic decision making across assigned areas/responsibilities; helping internal partners/stakeholders to maximize their commercial success
• Proactively evaluates/assesses the relevant market landscape, monitoring changes in market dynamics, competition, clinician and patient practices and needs, as well as other related factors
• Acts as a thought partner and consultant to assigned teams, functions and other relevant partners/stakeholders
• Partners with brand directors and other stakeholders to review and contribute to lifecycle, brand and tactical plans and provide supportive insights to help further inform, shape and influence business strategies and plans
• Provides long-range business plan forecasts for assigned brands
• Where appropriate, may partner with others, to review and integrate product- and market-specific assessments, analyses and the like into portfolio-wide (across all Genentech therapeutic areas and/or beyond) assessments for executive level reviews and decision-making
• Where assigned, helps internal partners/stakeholder to identify and set key performance metrics for assigned brands
• Employs a wide range of market analysis efforts and techniques, including penetration assessments, market share analyses, product concept testing, etc.
• Provides the continuous, in-depth cumulative perspective on the relevant market(s) and brand(s)
• Acts as the expert on the customer landscape, providing in-depth information and insights into customer practices and needs. As such, also possesses and applies in-depth product and therapeutic area knowledge
• Uses his/her understanding of the "broader market" to link insights and recommendations to wider strategic issues, challenges and/or opportunities:
• Synthesizes relevant analyses and prior research findings to develop a cumulative perspective of the relevant market(s) and associated factors; translates such into clear and meaningful implications for communication and review by internal partners and other stakeholders
• Recommends research/analysis methods and matches these to project objectives; understanding potential and/or limitations of various sources and methodologies
• Draws substantive conclusions from results; identifying implications, challenges or other opportunities and delineating clear next steps
• Develops a "command" of data/info sources and a sensitivity to biases
• Performs accurate analyses and thinks creatively about different ways to analyze data and information
• Defines questions and required data; appropriately comprehends quantitative methods and analysis techniques
• Identifies themes across projects and information sources; performing appropriate, aligned and integrated "meta-analyses"
• Where assigned, tracks key performance metrics for assigned brands
• Where assigned, creates, validates and refines forecasts for in-line products, new indications and new market opportunities. Presents updates on revenue information to senior management
• Where applicable, hires, develops and oversees the work of direct reports
• Complies with all laws, regulations and policies that govern the conduct of Genentech activities

We are seeking a candidate for a postdoctoral position in the Department of Molecular Biology, to investigate vascular processes.  Research topics include Notch, BMP, Tie2 and EphB4 signaling pathways, and roles of microRNAs in vascular biology.

• Acts as lead contact for patient insights projects and ongoing consulting regarding the assigned franchises and brands
• Provides an objective commercial viewpoint, based on an in-depth understanding and analysis of patient dynamics and trends as these relate to the assigned franchises and brands: 

• Proactively and continuously monitors the external landscape, as it relates to assigned franchises/brands and existing or potential patient populations. Identifies, assesses and communicates patient trends (e.g., access, reimbursement, personalized healthcare needs, etc.)
• Acts as a thought partner and consultant to all relevant teams, functions and stakeholders
• Works closely with team members in Market Planning, other groups in Market Analysis & Strategy, Franchise Marketing, Patient Marketing, eMarketing and others to identify and plan for patient and related research programs and studies. Identifies, and/or participates in the identification of, critical opportunities for growth, and helps to ensure key patient insights are embedded in the strategic direction of Genentech's current and future businesses
• Participates in the identification of strategic issues or questions to be answered by research projects and/or through leverage of existing analyses and information.  Helps shape and structure patient and related market research programs and studies.  Participates in the definition of questions and required data. Works with his/her manager to identify themes across projects and information sources
• Performs regular and ad hoc patient and related market research, analysis and scenario modeling using primary research from commissioned studies and/or secondary research and analytics. Regular analysis may include patient segmentation, market share analysis and assessment, etc. Employs various analytical methodologies and techniques; and demonstrates understanding of potential and/or limitations of data sources and analytical methodologies. Develops a "command" of data and information sources and a sensitivity to biases.  Performs accurate analyses and thinks creatively about different ways to analyze data and information
• Synthesizes data and identifies implications of patient and related influences relevant to Genentech's current and future business. (Where applicable, performs "meta-analyses" across projects and information sources where similar themes or opportunities may exist.) Draws substantive conclusions from results; identifying implications, challenges or other opportunities, and delineating clear next steps
• Provides internal business partners and stakeholders with a cumulative set of recommendations on patient strategies, plans and tactics (includes risk assessment and mitigation, new business opportunities, line extensions and the like)

• Provides strategic and operational patient insights and recommendations to support various Genentech business planning processes, e.g. long-range Business Plans, 3-year brand and 1-year tactical plans
• Acts as an industry expert on patient research and the general patient landscape, providing ongoing in-depth information and insights to internal partners and stakeholders
• Regularly communicates key patient and related market information to various teams and individuals throughout Genentech
• Complies with all laws, regulation...

• Responsible for maintenance, calibration and replacement of equipment in the department (HPLCs, AKTAs, spectrophotometers, lab supplies, etc.), maintenance of laboratory clean up schedules, and documentation systems.
• Work with your manager to prioritize tasks and assignments and make recommendations to maximize efficiency and productivity based on department needs.
• Support the department by maintaining inventory of supplies and buffers.
• Increase the efficiency and effectiveness of the department by using 5S principles to facilitate our daily operations. 
• Act as a single point of contact for resolving laboratory and facility related issues in a fast-paced environment with tight timelines.
• Work with a large group of researchers as well as outside partner groups and vendors to ensure optimal use of laboratory facilities.
• May assist co-workers with purification studies

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.

Senior Health Economist (E5)/ Principal Health Economist (E5A)

RESPONSIBILITIES INCLUDE:

-Design, develop, conduct and manage HEOR studies for assigned products and indications in the cardiometabolism or neuroscience therapeutic areas

-Develop, maintain and apply in-depth knowledge of role, including disease state and clinical topics, market/ customer landscape, and emerging issues.  

-Work independently with minimal guidance, direction and mentoring from manager and others to clarify directions and expand knowledge and skills

-Proactively collaboration with various functions including medical directors, commercial, managed care marketing, development and other gMed functions to ensure alignment of activities with key partners and stakeholders

-Develop HEOR strategy for the medical plan for pre-launch and/or post-marketed products.  

-Design and execute prospective and retrospective outcomes research studies, in collaboration with academic consultants and contract research organizations.  -Develop economic models and AMCP dossier chapter to support launch. Manage budgets, timelines and deliverables as planned.

-Lead and/or participate in HEOR and cross-functional projects. 

ABILITIES:

- Demonstrate strong leadership and communication skills; can contribute to the development of vision and strategy in Medical Affairs teams.

- Demonstrate abilities to manage complex responsibilities, to include integration across multiple projects and priorities

-Strong orientation to teamwork: works collaboratively, effectively and efficiently with others in a matrix project team environment

The Senior/Principal Health Economist is part of the broader Oncology Medical Unit organization and provides health economics and outcomes research, modeling, reporting, and other relevant analyses, within applicable legal and regulatory guidelines, which can be used to quantify the value of Genentech products in economic or societal terms. 

The Senior/Principal Health Economist will work with multiple products and indications within the Oncology portfolio and will support cross-functional Genentech and Roche teams by recommending, developing/conducting and advising on HEOR research and modeling strategies, and by developing medical and payer value propositions, portions of product dossiers, and other scientifically-based communications. 

This team supports strategic decision-making for late-stage development and across the product lifecycle. The Senior/Principal Health Economist helps set Genentech HEOR strategies, direction, objectives, and plans for innovative, effective and efficient execution. 

The Senior/Principal Health Economist will be fully accountable for compliance with all laws, regulations and policies that govern the conduct of Genentech activities. As a manager and coach of others, the AD/PHE is not only accountable for his/her own compliance, but also for the compliance of all individuals in his/her team. As such, s/he leads the way and leads by example by demonstrating full knowledge and commitment to all applicable policies. The Senior/Principal Health Economist monitors adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required. ¿

Responsibilities:

Incumbents are generally expected to:

• Functional lead for HEOR activities for the molecules and indications assigned, including participation in design and conduct of studies as needed

• Set and manage to outside spend budgets for multiple projects and products, including assuring that direct reports meet budget commitments and develop financial management skills

• Manage one or more health economists or other HEOR staff, with less than half of his/her time devoted to management

• Including hiring, development and ensuring technical excellence

• Directly engaged in designing, developing and conducting HEOR studies with strategic impact for the molecules for which she/he is responsible

• Maintain strong, positive relationships with senior internal stakeholders across Genentech and Roche 

• Lead development of the vision, strategic and tactical plans, resource and budget plans, for the products and indications under his/her responsibility.  Includes establishing annual and longer-range plans, goals and objectives, and effectively aligning these with Genentech and Roche cross-functional research, development and commercial strategies and objectives.

• Lead and manage execution to ensure work is completed on-time, on-target and within-budget, with the highest levels of accuracy and relevance, and in consistent compliance with legal and regulatory guidelines, Genentech and Roche policies & procedures:

• Working collaboratively, effectively and efficiently with all internal and external customers, partners, stakeholders and influencers

• Develop and cultivate relationships with key KOLs (Key Opinion Leaders) and other thought leaders, to support HEOR strategies, plans and objectives and provide strategic, critical influence for Genentech's product pipeline and portfolio

• Act, and is accountable for others in his/her team acting, in complete & total compliance with all laws, regulations and policies.

• Utilize only approved resources and messages to meet goals and targets

RESPONSIBILITIES INCLUDE:

-Design, develop, conduct and manage HEOR studies for assigned products and indications in the immunology and infectious disease therapeutic areas.

-Develop, maintain and apply in-depth knowledge of role, including disease state and clinical topics, market/ customer landscape, and emerging issues.

-Work independently with minimal guidance, direction and mentoring from manager and others to clarify directions and expand knowledge and skills.

-Proactively collaborate with various functions including medical directors, commercial, managed care marketing, development and other gMed functions to ensure alignment of activities with key partners and stakeholders.

-Develop HEOR strategy for the medical plan for pre-launch and/or post-marketed products.  

-Design and execute prospective and retrospective outcomes research studies, in collaboration with academic consultants and contract research organizations.  -Develop economic models and AMCP dossier sections to support launch.

-Manage budgets, timelines and deliverables as planned.

-Lead and/or participate in HEOR and cross-functional projects. 

ABILITIES:

- Demonstrate strong leadership and communication skills; can contribute to the development of vision and strategy in Medical Affairs teams.

- Demonstrate abilities to manage complex responsibilities, to include integration across multiple projects and priorities.

-Strong orientation to teamwork: works collaboratively, effectively and efficiently with others in a matrix project team environment.

The successful candidate will be a key member of the Cross-Portfolio Governance (CPG) team within PPP/Pharma Portfolio Management. The CPG team establishes and manages governance operations and decision-making processes for late stage development to enable well informed and timely corporate decisions on portfolio investment and prioritization.

The manager of LSPC Operations works in close partnership with the late stage portfolio committee (LSPC) Business Manager and is responsible for providing project management support for CPG key initiatives and for leading and managing the monthly LSPC decision-making operations cycle.

Responsibilities

• Lead and manage the monthly LSPC agenda preparation process with key stakeholders in late stage teams in efficient, collaborative and transparent way
• Write minutes for the LSPC monthly meetings
• Anticipate, identify, manage and communicate risks to the execution of the monthly operations cycle
• Support LSPC Business Manager in preparing recommendations and proposals for meetings with LSPC Chairs and other senior leadership
• Maintain LSPC Charter, process documentation and required templates for team presentations for committee decisions
• Manage CPG communications with cross-functional stakeholders
• Guide, educate and support late stage teams, finance, PPM and other key stakeholders though the LSPC operational processes
• Actively contribute to best practices and continuous improvement
• Provide project management support to key projects, and programs led by CPG members and sponsored by senior leadership

Job Skills and Expectations

• Excellent project management skills
• A strong understanding of pharmaceutical/biotech industry, drug development process and trends, and business strategy
• Customer service orientation and attention to detail
• Strong oral and written communication skills
• Experience managing process improvement implementation and change
• Excellent interpersonal skills, including clear, succinct and timely communication and proven ability to foster important relationships with customers and key stakeholders.

• Coordinating meetings and events making travel arrangements, preparing reports and interacting with customers and vendors.
• The SAA must be able to utilize good judgment in managing calendar appointments and access to Manager’s schedules.
• The SAA will also be responsible for coordinating, assembling and packaging presentations, agendas and other meeting materials.
• The SAA will be expected to manage conference room scheduling and coordinate meetings with other Managers within GI and across the Company.
• They must be professional in demeanor and appearance, and courteous and friendly.

All candidates are encouraged to apply, however a preferred candidate has been identified.

The ideal candidate must have demonstrated the ability to handle confidential, complex and sensitive information, and the ability to establish administrative processes and procedures to assist the group with projects and tasks.  Candidate will provide accurate and effective administrative support for Managers within the group and coordinate administrative duties with other Administrative Professionals to provide seamless support for the group.

*Manage multiple schedules with heavy calendaring of complete meetings.  Arrange, coordinate and support meetings, events and activities both on and off-site.

*Identify and anticipate needs of the group and plan work activities accordingly.  Look for areas of activity overlap with co-workers and leverage resources to maximize time, resources and dissemination of information.

*Generate, disseminate and maintain documents and information.  Develop, implement and evaluate department work processes and procedures.  Manage deadlines related to business planning as well as special projects.

*Collaborate with Admin team to support complex projects and deadlines.

*Understand and troubleshoot from a broader perspective and anticipate the impact of office admin problems and solutions on the other areas.

* Understanding and experience with approval processes for vendor contracts, ideally within GNE, is highly desirable. A large fraction of the workload for this position will be administering contracts for HEOR research partners.

General office responsibilities include but not limited to:

 *Schedule and coordinate staff onsite/offsite meetings, assist with special projects, schedule travel for staff, process payment and expense reports, plan, schedule and coordinate WebEx’s and teleconferences, maintain files, order department office supplies, order catering and other supplies for a variety of meetings and events, fully utilize MAC and software applications.  Exercise independent judgment and discretion of sensitive/confidential information.

Purpose

In partnership with senior leadership, responsible for strategic direction and execution of medical communication plans for marketed products, pipeline molecules, and therapeutic area support. Oversight for MC scientist teams. Ensures product specialist resources are positioned to support current and future company needs. Accountable for the long-range financial planning and resource management for med comm product support.  Liaison responsible for directing and influencing corporate groups to achieve shared goals and objectives.

Job Description:

• Oversight for daily operations of the MC scientist teams, including responding to unsolicited requests, creation and maintenance of document response library, support for product launches, internal team support, and responding to label changes

• Provide oversight and leadership to the management team including strategic planning and tactics aligned with corporate and product priorities, champion department goals, and brand planning

• Year over year finance and resource budget planning as well as future resource forecasting for therapeutic area

• Accountability for representing MC at multidisciplinary senior-level cross functional committees including: Label committee (LC), reprint dissemination committee (RDC), healthcare compliance committee (HCC), patient communications committee (PCC), medical communications leadership team, and other committees where relevant; safety sub-teams (SST), promotional review committees (PRCs), Medical teams, major scientific meeting taskforce teams

• Career development of future leadership and succession planning for manager teams. Empower his/her staff to make sound decisions, and delegate as appropriate

• Develop and maintain collaborations with multiple corporate partners including Roche global, Novartis, Merk-Serono, Abbott, Biogen-Idec, and OSI pharmaceuticals

• Ensuring effective and efficient cross-product and cross-activity support via senior leadership collaborations

• Maintain awareness of the present state of business and needs by maintaining relationships with all relevant areas within and external to the Medical Affairs Organization

• Interacts and represents MC department with internal customers including but not limited to: Sales, Marketing, Clinical Operations, Clinical Science, Regulatory, Legal, and Safety.  Frequently represents MC outside of department  

MSDs are generally expected to perform their responsibilities with limited guidance from Medical Directors and/or other relevant internal partners and stakeholders:

·         Implement the medical affairs plan for the assigned drug(s) /indication(s), working with Medical Directors, mainly on PhIV clinical programs and their publication plans

·         Collaborates with Commercial and provides scientific input for the development and review promotional materials, documents and presentations developed for the assigned drugs and/or indications (signing off of any promotional material remains the responsibility of the Medical Director of the assigned drugs and/or indications)

·         Support his/her manager, as and when requested, in developing relevant parts of the medical affairs tactical plans, and/or completing other special projects such as preparation and review of training materials for field forces

·         Demonstrate ever-increasing competence in implementations of all aspects of medical plans

·         Competently and collaboratively interact with a host of internal and external partners and stakeholders

·         Consistently complete all assigned responsibilities on-time and on-target.

·         Develop and cultivate important relationships with internal and external partners and stakeholders. Includes investigators, thought leaders and KOLs (key opinion leaders)

·         Stay informed and abreast of the external landscape as it relates to assigned drugs and/or indications and the associated therapeutic area(s)

JOB DESCRIPTION - PRIMARY DUTIES AND RESPONSIBILITIES:

1. Clinical Trials & Programs 

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 GNE Medical Affairs, 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...

Main Purpose of the Position:    

·         Support the development, implementation and management of the overall environmental control program in SSF Drug Substance and Drug Product Manufacturing following, cGMP regulations, Genentech and Regulatory requirements.

·         Provide Quality oversight from and critically evaluate EM issues, discrepancies, Media Fill data, airflow evaluations, and assess facility/process changes.  

·         Develop solutions to complex issues and Quality initiatives with inter-organizational impact.

·         Perform tasks and work to achieve company goals and organizational objectives.

Technical Duties/Responsibilities:

·         Provide oversight of the Environmental Monitoring (EM) program ensuring consistency with company/regulatory policies and procedures.

·         Present and provide rationale of EM program during periodic audits and regulatory inspections.

·         Provide input in the preparation of regulatory submissions.

·         Provide input into investigations involving suspect equipment, utility or facility failures resulting from EM activities.

·         Provide Quality oversight throughout the Drug Substance and Drug Product Manufacturing areas. 

·         Provide technical assessment and approval for changes to the EM program.

·         Collaborate with departments to ensure that EM activities are executed efficiently and effectively.

·         Provide oversight to the Media Fill program and create Media Fill protocols and summary reports.

·         Execute Airflow Visualization studies and create summary reports.  

·         Provide guidelines for area/system Shutdown Authorization Request (SAR) activities.

·         Ensure proper policies and procedures are established to guide EM efforts.

·         Ensure department representation on relevant project teams.

·         Identify, design, and implement environmental monitoring process improvements.

·         Communicate group performance against established metrics to Quality Management.

Position Summary:

Provide Project and Program Management for IT business solutions that have significant impact to the enterprise in North America ERP Demand to Supply, Manage Finance, and Order to Cash solutions.

The position will work closely with the North American ERP organization to plan, manage and deliver process and system initiatives. As a senior project manager this individual will lead the deployment of SAP systems and processes across Pharma in the North American region. Responsibilities include future SAP site implementations, enhancements, functional transformation projects and infrastructure related projects.

This position provides expertise needed to effectively implement projects and continuously improve processes. This individual will also partner with business project managers while working with the Pharma IT organization to drive requirements and successfully complete projects.

The purpose of the department is to a) provide IT services for the NA regional ERP solutions, b) deliver enhancements and projects for the regional ERP solutions, c) ensure the services are delivered to established customer SLAs, and d) provide a local/regional presence for the ERP IT group.

2-3 most important contributions of this department

Understand the local and regional business needs for the ERP solutions. 
Deliver operational services for the regional and local Demand to Supply, Manage Finance, and Order to Cash solutions.
Deliver enhancements and projects for the Regional Demand to Supply, Manage Finance, and Order to Cash solutions.

Main customers are the regional/local Finance group, regional/local Tech Ops group,  Local Order to Cash group.

Main PI collaborations are with ERP Architecture, global ERP Solution Owners, Business Project managers, IT Application Technical Leads,  AE&O.

Major Responsibilities:

• Developing work plans, managing deadlines and coordination of project team and sub-team activities
• Estimating project skill requirements, and then working with resource deployment managers to identify appropriate resources and manage their integration into the team
• Defining and agreeing on deliverables , risk management and milestones
• Setting and controlling scope
• Communicating status and vision to client management and stakeholders
• Create a collaborative environment which promotes communication across the organization, at all levels: including but not limited to the Steering Committee, Enterprise Architecture, Departmental Managers and Information Technology.
• Provides overall team management, including regular evaluations
• Prepares and delivers executive presentations and facilitates workshops/meetings.
• Ensures procurement and sourcing procedures are followed.
• Provides Functional Manager with feedback on team member performance.

Summary

Responsible for producing innovative Biotherapeutic medicine by interfacing with production systems and controls in a cGMP manufacturing environment, maintaining areas of responsibility in a high state of inspection preparedness, managing the performance of both manual and semi - automated warehouse processes to support manufacturing unit operations, collaborating with the network to implement multi-site process improvement initiatives/CAPAs and executing department objectives to support strategic goals.  Partners with the business to deliver business results focused on establishing and improving business processes to improve reliability, increase simplicity, and enable growth, while utilizing a DMAIC data-driven, problem solving methodology to deliver tangible business results.  Responsible for business process analysis, design and optimization to enable the routine delivery of exceptional performance. 
 

Job Responsibilities

Applies a complete understanding of theories and concepts from one's technical/professional discipline to independently address a broad range of difficult problems.May determine methods and procedures on new assignments.

Essential
¿ Manage and resolve technical and compliance issues with Quality, Maintenance, Calibration & EH&S.
¿ Lead teams to execute internal/cross functional and network related projects that may include investigating, analyzing, formulating solutions, identifying improvement opportunities, documenting processes, training, process/system performance improvement and cascading results to management.
¿ Partnering with the customers, communicating/coordinating/bringing together key stakeholders, and delivering real value-add sustainable solutions.
¿ Act as SPOC for compliance or regulatory agency issues within the department
¿ Identify the technical, procedural and equipment issues that may compromise production and compliance, working closely with cross functional / network groups to identify and implement solutions.
¿ Implement and follow through on corrective and preventative actions for variances or regulatory observations.
¿ Represent the department in reviewing and approving all production related documentation requiring approval such as process validation protocols and final reports, planned and unplanned variance reports, documentation change requests, engineering and facility change requests, and validation protocols.
¿ Supports department to meet corporate goals and department objectives.
¿ Representing the department as the change agent.
¿ Deliver project goals on budget and on schedule.
¿ Make recommendations to Management based on business case and analyses.
¿ Lead decision making support and make recommendations regarding best options.
¿ Communicate proactively with stakeholders regarding progress, issues and plans for resolution.
¿ Develop and use project plans to coordinate participants and track and report progress.
¿ Ensure improvement methodology and tools are utilized effectively to maximize benefits.
¿ Operate with a high degree of autonomy and professionalism; successfully prioritize workload in accordance with business goals.
¿ Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes.
¿ Innovative and effective in solution development, risk mitigation, and execution.
¿ Work collaboratively with network to implement multi-site process improvement/CAPAs to mitigate compliance related risks.
¿ Ensure that all operations are performed with 100% compliance to documentation cGMP standards.
¿ Ensure maintenance of a safe warehousing work environment that complies with company and state regulations.
¿ Submit reports and compile data for trending and identifying problem areas.
¿ Collaborate with other departments to address issues and meet deadlines.
¿ All employees with jobs that require access to the Warehouse must be able to pass the Transportation Security Administration (TSA) Security Threat Assessment (STA).
¿ Ensures the integration of environmental health, safety, and security into the business processes, systems, and programs while reporting safety and environmental incidents including injuries, illnesses, and safety suggestions within one’s functional area.  Fosters a positive safety culture in which no one gets hurt.

• Focuses on process optimization and continuous improvement of existing Identity & Access Management processes and tools
• Follows established processes and standards in the execution of daily duties and job function

• Develops the Identity and Access Management services
• Promotes the Identity and Access Management services with all customers
• Supports the integration process of new or updated components by following established standards and providing the expected deliverables for handing over the service to operational teams and customers.

• Supports the integration of registration processes within the company’s identity management solution with focus on improving the operational environment, processes and procedures including data migration activities
• Follows appropriate SOPs and instructions required for the integration of registration services

• Manages the configuration and master data by assessing and specifying the possible need of data quality improvements
• Applies change management processes while managing the Identity & Access Management process integration
• Support the integration of business processes and applications by leveraging the Identity and Access Management infrastructure, tools and directories and following project management best practice.

• Manages the analysis, design and handover of access registration processes to the operational teams
• Ensures proper documentation and training material regarding registration processes is in place and kept up-to-date
• Manages the identity and access management processes to meet OLAs/SLAs by adhering to regulatory and qualitative requirements
• Increase process efficiency and cost effectiveness while providing identity and access management services
• Manage the integration of registration processes with focus on improving the operational environment, processes and procedures
• Manages and maintains the registration process portfolio
• Monitors and verifies the effectiveness of registration processes through established KPI and trend analysis
• Contributes to audit processes
• Based on business needs, identifies and proposes innovative, integrated, economically viable solutions
• Integrate identity and access management processes by meeting SLA requirements
• Supports that all solutions, documentation and procedures are implemented and maintained in a fully qualified and current state as applicable
• Registration processes are clearly communicated and trained
• Continuously strives for increase the skill level and expertise in the corresponding area
• Keeps abreast of business needs by maintaining close relationship to service management and other support services teams.
• Ensures compliance to Roche and Informatics Standards for technology, monitoring and support tools, SOPs and policies
• Ensures that documentation is current and accurate, SOP’s are understood and adhered to and platforms operate in highly secure and qualified environments in compliance with Audit, Regulatory and Validation requirements
• Ensures SLA requirements are understood and the required processes are implemented and managed to support compliance
• Provides shared platform support services as agreed (SLA or other) with the SM functions and other service consumers
• Provides input to support service levels and costs
• Fosters a working environment that encourages team members to fully contribute to achieve Roche’s goals
• Actively provides feedback to customer and team seeking for process improvements and efficiency gains
• manages the different integration projects within the portfolio to integrate new/existing IM applications into the service
• ensure standardization and globalization of application registration services by improving the operational environment, processes and procedures
• interface with the corresponding Engineering team if new features/interfaces are required
• ensure proper testing of application registration integration
• handover of new productive application registration processes to the operational team(s)
• create metrics/key performance indicators and develop/apply ...