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...

CORA is part of the broader PDR organization that interprets the needs of worldwide

 health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Roche’s global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. CORA Program Directors chair moderate to higher complexity Promotional Review Committees (PRCs), for different products and product development phases, as business needs dictate. CORA Program Directors are responsible for leading and managing the assigned PRCs and their activities; providing strategic and operational leadership in the areas of advertising and promotion for Roche pharmaceutical products and devices. Associate Program Directors are expected to perform their responsibilities with increased independence. 

Intact & Cross-Functional Teams:

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

Commercial Regulatory Affairs:

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

As a product manager, you will be responsible for supporting the preparation, assembly, and review of both product and facility-related Chemistry Manufacturing and Controls (CMC) regulatory submissions.

The successful candidate must have broad regulatory and technical knowledge applied to develop, execute and provide oversight in the execution of complex regulatory initiatives and strategies.

The successful applicant will be required to apply practical scientific understanding of drug substance manufacturing facilities and knowledge of pharmaceutical manufacturing to facilitate the preparation and review of regulatory submissions and ensure compliance with applicable regulations and guidelines. The individual will lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and personalities.  The candidate will support ex-US filings, as appropriate and as requested by corporate partners.  Additional responsibilities may include leading or participating in departmental operational excellence and business process initiatives.

Self-supervisory with senior management guidance on strategy. Exercises considerable latitude in determining objectives and approaches to assignments.

The Regulatory Manager must maintain a high level of professionalism, efficiency, and commitment. The successful candidate will demonstrate effective problem solving, strong understanding of regulatory affairs, excellent interpersonal skills and the ability to prioritize multiple tasks. Must have a proven ability to communicate effectively in both a written and verbal format. Ability to work both independently or collaboratively in a team structure. The incumbent will be interacting with FDA to facilitate timely review and approval of submissions.

The Clinical Pharmacology Department at Genentech, Inc. is seeking a Ph.D. level Associate Scientist or Scientist who is driven to understand the clinical pharmacokinetics and pharmacodynamics of novel drug candidates in the area of Biologics.  This individual will be primarily responsible for the clinical pharmacology activities of Biologics in clinical development. This person will have responsibility for the Clinical Pharmacology strategy in order to ensure that appropriate dose/route/schedule decisions are made using the state of the art modeling and simulation strategies that are aligned with project needs. This will be accomplished by working in close partnership with Clinicians, Biostatisticians, Clinicians and project teams.  Responsibilities will include planning and reviewing study designs, analysis plans, data analysis, interpretation of PK/PD as well as planning, implementation and organization of regulatory filings (worldwide) and presentation of data at cross-functional teams, department meetings, conferences and regulatory meetings (worldwide). Additionally this individual will also be directly involved in leading project sub-teams and representing the function at cross-functional project teams.

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

Regulatory Program Management is part of the broader PDR organization that interprets the needs of worldwide health authorities and provides regulatory intelligence necessary to generate and present information that meets the needs of health authorities, patients, purchasers and prescribers for Roche’s global Pharma Medicines Division, which includes all therapeutic areas and all phases of product development from early development to post-marketing. PDR is responsible for the timely submission of applications to health authorities for approval of new products and line extensions. PDR is committed to regulatory strategies that are the most innovative, ethical, and influential in the industry. Like others in Regulatory Program Management, Program Directors are assigned their responsibilities by therapeutic area, and are assigned projects for different product development phases, as business needs dictate. Regulatory Program Management Program Directors provide regulatory leadership for one or more regional or global development projects. Regulatory Program Management Program Directors are responsible for the development and implementation of regulatory strategies to facilitate the development and approval of Roche medicines for human use. Program Directors are expected to lead more complex projects and represent PDR to cross-functional teams and groups with increased independence. Regulatory Program Management Program Directors are responsible for working cross-functionally and coordinating regulatory-related activities across PDR functions and with other internal partners.  Regulatory Program Management Program Directors serve as the principal interface with primary reviewers from health authorities and for other interactions with relevant regulatory-related external parties; managing the strategies for and execution of these interactions.

DUTIES & RESPONSIBILITIES:

• Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.  Briefs teams and management, as appropriate
• Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices
• Provides regulatory expertise and leadership to site, regional or global cross-functional teams and other groups
• Stays abreast of therapeutic area product development and other related business strategies and plans 
• Serves as the primary PDR representative on one or more regional or global projects at any one point in time; typically complex projects
• Analyzes data, the regulatory environment and business objectives to recommend priorities
• Leads teams in developing, implementing and delivering the cross-functional regulatory strategy for each project or related assignment.  Plays a lead role in helping ensure effective balance of time, cost, quality and risk so that regulatory strategies meet the needs of patients, prescribers, payers, regulators and Roche
• Plays a key role in assuring business objectives are understood and taken into account during regulatory strategy development
• Identifies and aligns cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment
• Works with others to ensure timely and appropriate cross-functional alignment and appointment to RAFT for each assigned project
• Presents and obtains approvals for the cross-functional regulatory strategy to various teams, committees and senior management
• Serves as the site, regional or global principal interface with primary reviewers from regulatory authorities or for other regulatory-related interactions with other external parties. Establishes effective working relationships with regulatory authorities and directs regulatory interactions for internal site, regional and/or global teams
• Provides internal teams with direction on regulatory authority interactions
• Manages ongoing RAFT meetings. Including providing ongoing leadership of regulatory deliverables and guidance on compliance, timing and other relevant matters.  Manages RAFT resources
• Ensures cross-functional perspectives and expertise are incorporated into regulatory plans prior to decisions being made
• Manages decision-making and conflict resolution surrounding regulatory issues within cross-functional teams, including coordination between other business teams and RAFT team. Ensures appropriate escalation to team leaders or functional management, as necessary 
• Oversees, coordinates and provides a first-line of internal approvals for regulatory submissions and other relevant regulatory documentation
• Responsible to ensure all PDR deliverables associated with each project or other assignment are completed within defined timelines and meet...

This position may be filled at an Associate Field Reimbursement Manager or Field Reimbursement Manager level.
 
The Territory for this position will cover New York City and New Jersey North. 

Candidate can live within any of  these territories, but would prefer New York City.

 
The Retinal Field Reimbursement Manager (RFRM) helps to minimize reimbursement barriers for patients and providers and, therefore, helps to optimize access to Genentech products in the assigned therapeutic area.  The FRM works closely with internal partners, supporting targeted accounts, and helping resolve reimbursement issues or concerns. They also develop ethical and customer-oriented reimbursement tactics, and proactively communicate payer criteria/terms and practices, as these relate to reimbursement for the assigned GNE products.

• Works with internal partners to review franchise, managed care, and divisional field sales business plans and objectives
• Acts as a subject matter expert on the payer landscape relevant to the assigned Genentech therapeutic area(s)/product(s)
• Acts as a conduit between the Field and Home Office Genentech functions for all public and private payer policies and practices that impact patient access to Genentech products
• Assists Coverage & Reimbursement with individual case management needs
• Develops ethical and customer-oriented reimbursement tactics
• Trouble-shoots field account reimbursement issues, needs, concerns, or challenges
• Spends majority of time visiting customer accounts in the field
• Proactively communicates and explains Genentech-specific reimbursement programs, policies, procedures and resources
• Works with relevant state, institutional or other societies
• Complies with all laws, regulations and policies that govern the conduct of GNE activities
• Business travel, by air or car, is regularly required
• In addition to passing Genentechs background screening, the employee must submit to and pass additional background screening as required by some institutions and health facility sales accounts (additional screening requests may include but are not limited to background checks, immunization, TB, HIV, hepatitis, and drug screening)

"This position requires significant use of either a company provided or personal vehicle to perform the essential duties and responsibilities of the role.  As a result, Genentech, Inc. (Company) from time to time will check your motor vehicle record for purposes of determining your eligibility for driving a Company vehicle or driving any vehicle on Company business."

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...

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.

Level - E3/E4

Main Purpose of the Position:    
·         Solve a wide range of difficult Manufacturing Quality Assurance and Product Release issues that impact multiple functions following cGMP regulations and Genentech standards 
·         Perform assigned tasks and work to achieve company goals and department objectives.
 
Job Duties/Responsibilities: ·         Follow company policies and procedures.
·         Maintain a state of inspection readiness.
·         Provide input to the development of personal performance goals and departmental objectives.
·         Collaborate with Management to establish and meet targets and timelines.
·         Support routine operations and allocate assigned resources.
·         Manage competing priorities.
·         Serve as the Quality representative on cross-functional and multi-site teams.
·         Identify, design, and implement process and system improvements.
·         Lead and participate in the design and implementation of department and cross-functional initiatives.
·         Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems.
·         Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.
·         Serve as a technical subject matter expert (SME) in support of department functions.
·         Train personnel and internal customers on relevant business processes.
·         Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
·         Be accountable for behaviors as described in Genentech’s Core, Common, and Critical Competencies.
·         Perform any other tasks as requested by Management to support Quality oversight activities.
 

Technical Duties/Responsibilities:
·         Manage the product disposition program in support of manufacturing operations.
·         Review and approve master batch production records.
·         Collaborate with departments to ensure product release activities are executed efficiently and effectively.
·         Review and approve lot release documentation.
·         Provide technical assessment for process changes that may impact product disposition.
·         Provide Quality oversight to internal and external customers.
·         Provide input into investigations with potential product, process, or material impact.
·         Ensure process and documentation discrepancies are identified, defined and assessed.
·         Recommend final product disposition impacted by a deviation or discrepancy to Senior Management.
·         Create and maintain a system for tracking, trending, and reporting discrepancies identified and assessed by MQA.
·         Develop a system for tracking, trending, and reporting product release cycle times.
·         Monitor MQA activities to evaluate trends, and report repetitive anomalies, observations, and discrepancies to Senior Management. 
·         Represent MQA at cross-functional meetings to develop, review, and approve Commercial Quality documents.
·         Participate in the MQA review audit program and the Raw Material Reconciliation process.
·         Present and provide rationale for the batch release program during periodic audits and regulatory inspections.
·         Prepare, review, and approve relevant sections of regulatory submissions.
·  &nb...

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. 

Responsibilities:

Works with senior biostatistics staff and clinical monitors on clinical development plans, the design and conduct of clinical studies and in the evaluation, interpretation and preparation of study results. As part of a clinical assessment team, collaborates in the preparation and review of clinical assessments. For assigned clinical development project(s), provides statistically sound experimental design and data analysis input to meet project objectives and Health Authority's statistical requirements. Reviews all project protocols, author protocol statistical analysis sections and generate study randomizations. Develops study analysis plans as a team member; lead this effort for selected studies. Reviews case report forms to ensure that protocol objectives are met and project standards are maintained. Develops statistical programs as necessary to perform analyses, and verify data accuracy and validity. Co-author efficacy analysis results in the clinical study report. Supplies statistical input for filing submissions and in response to FDA questions. Provides support for publications. Keeps abreast of new developments in statistics, drug development, and regulatory guidance through literature review, workshop attendance, etc.

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.

• Perform business analysis activities to design, develop, and deploy solutions including projects, enhancements and upgrades for internal customers
• Analyze data processing problems related to gRED information and planning systems including the Planisware solution and the gRED portfolio analytics platform
• Lead and facilitate meetings with Director and VP level customers to determine organizational needs and requirements and develop solutions
• Manage 2–3 major projects of diverse scope across functional areas
• Create and/or assist with required project documentation practices such as user requirements, functional specifications and service level agreements
• Resolve technical and process incidents and problems according to Service Level Agreements
• Collaborate with internal support teams and external vendors to ensure and continuously improve system stability and optimal performance for deployed solutions

Position is responsible for the development, maintenance and advancement of the Enterprise Resource Planning (ERP) system recipes and master data used by SSF Clinical Supplies Management.  Successful candidates will represent the department as a subject matter expert and liaison between a variety of key internal and external stakeholders.  They will lead processes to ensure successful SAP data development, deployment, and maintenance and will ensure appropriate integration of CLARA, R3, and APO with supporting systems.  The successful candidate will be adept at leading cross-functional teams in problem identification and resolution.  They will be relied upon to work collaboratively and independently to solve emerging challenges inherent to rolling out new data applications.  The position will provide support of user needs for current and future applications for the Clinical Supplies Management department.  They will represent the department in interactions with the global business process management community and will proactively identify areas for improvement.  Additionally, the successful candidate will play an important collaborative role in the integration of the newly formed production services team.  To this end, the successful candidate must also demonstrate competency and/or aptitude as well as interest in broader aspects of materials management, master production scheduling, capacity management, and detailed scheduling.  In addition to their system expertise, they will bring a willingness to learn new skills and tasks that will allow them to successfully backfill other production services roles in a dynamic environment.

Job Responsibilities

Scope of Work - The Business Analysts will be responsible for creating the SAP Recipe in collaboration with data owners to enable materials and capacity requirements planning and successful execution. Responsibilities of this position include:

*Develop SAP recipes for load into system
*Coordinate and lead data strategy and execution meetings with site and network representatives
*Provide technical solutions to a variety of problems of moderate scope and complexity.
*Develop solutions that are imaginative, thorough, practicable, and consistent with organization’s objectives
*Adhere to change management processes to ensure data accuracy is maintained across systems
*Provide reporting and analysis required to manage key performance indicators
*Translate business requirements to technical specifications and collaborate with key stakeholders to complete requests
*Provide training on usage, enhancements and changes to business systems
*Work is performed under limited direction and guidance, with general instructions on new assignments
*Proactively recommend priorities, timelines, and resources for addressing emergent business needs
*Participate in developing courses of action that may impact multiple functions in the organization
*Network with senior internal and external personnel in own area of expertise. Represent organization on assigned projects
*Identify opportunities for improvement
*Lead cross functional and cross network teams in the identification and implementation of improvement initiatives