Rheumatology Brand Trainer

The Brand Trainer supports the Rheumatology Franchise (ACTEMRA and Rituxan) in which the responsibilities are a combination of Clinical Trainer and Sales Trainer. Therefore, the Brand Trainer must possess a thorough understanding of the assigned brands in addition to be able to create training programs for both new hires and advanced sales representatives.
• Determines the most effective approach to meet product learning needs of the specific brand business. Applies instructional design principles and adult learning principles to enhance content delivery.
• Establishes goals and learning objectives to design appropriate and effective curriculum by leveraging adult learning principles.
• Researches the clinical issues and leverages resources (internal and external) to support the learning objectives in designing and creating training programs and products.
• Prepares and/or oversees the preparation of clinical training products and programs such as classes, workshops, learning modules, poster books, and other job aids and materials for distribution to CT&D customers and program participants.
• Develop Brand training programs as identified from Sales and Marketing teams focusing on Brand strategies and tactics which will ensure significant impact on increasing business.
• Facilitates Foundation (Phase I), Core (Phase II), and Continued (Phase III) Training Classes – skilled at group facilitation and group learning exercises.
• Designs and implements metrics to measure clinical training programs and products impact, effectiveness, appropriateness, and utility.
• Filters and distributes educational resources (i.e. clinical papers) to the CT&D customers and other appropriate audiences while remaining contentious of legal and regulatory parameters.
• Collaborates with all CT&D customers and resources: Sales, Marketing, Development, Medical Communications, Clinical, Legal, Regulatory, Library Services, etc. to ensure consistency, avoid redundancy, and that needs are met and leverage internal resources thereby ultimately, enhance training programs.
• Communicates appropriate Commercial Training and Development (CT&D) programs and resources to all customer segments to help support the Commercial Organizations strategic goals
• Participates as an active member on Commercial and Brand product teams
• Facilitation of “Selling Excellence” training programs that will enhance the effectiveness of the field sales organization
• Participates on CT&D internal training initiatives

...

We are recruiting for the position of Service Provider Strategy Lead to join our international Product Development Quality Assurance (PDQA) team.

Reporting to the Team Lead for Service Provider QA Strategy the ideal candidate will be responsible for the design and implementation of the Service Provider risk management and audit strategy across the GLP, GCP, GPVP areas. The role works in partnership with Procurement/Outsourcing Functions and the PDQA GLP, GCP, PV Strategy Leads to ensure that Risk Assessments are maintained across the inventory of Service Providers engaged globally (gRED, pRED, PD, GPS/gMED) and at Affiliate Level. 

 

This role monitors activities outsourced to Service Providers through periodic risk assessment, risk-based routine audits and provides ongoing support to mitigating actions. It also provides actionable data to Senior Procurement/Outsourcing functional management based on analysis of data (audit/inspection/risk) and identification of trends.

The ability to influence business partners in the area of service provider risk and quality management is essential to proactively identify and address issues with the skill to ensure that service provider quality issues are addressed in a timely manner and that the relevant management functions in the organizations are kept informed.
Key responsibilities and tasks:

• Design and implement the PDQA Service Provider risk-based strategy for risk management and audit activities
• Define/maintain the “audit/risk universe” of Service Providers based on input from Procurement/Outsourcing functions and PDQA GxP Strategy Leads
• Partner closely with the GxP Strategy Leads, Procurement/Outsourcing Functions to ensure that risk assessments are maintained for Service Providers to determine which audits will be conducted and where risk mitigation activities should occur. 
• Develop and implement a GxP risk based strategy to deliver an audit program and quality oversight model for service providers within service category areas. 
• Assess specific risk areas on an on-going basis, communicate to PDQA senior leadership and propose modifications to PDQA strategy where necessary 
• Develop and maintain risk assessment tools 
• Assess data/metrics from audits, inspections and risk management activities for compliance trends and risks 
• Develop communication tools (reports/dashboards) for audit and inspection metrics and trends
• Escalate significant compliance issues to PDQA Management
• Represent QA on Service Provider sourcing initiatives and Strategic Alliance or Category governance teams, participating in Service Provider due diligence visits where appropriate.
• Support regulatory authority GCP inspections at service providers.
• May lead or participate in GCP audits at service providers
• Provide leadership and direction to PDQ/PDQA and our customers/stakeholders on GxP related activities/issues related to Service Providers  
• Establish strong partnership/relationship with key stakeholders in Procurement and Outsourcing functions
• Review and provide feedback on service category area risk mitigation plans/CAPAs
• Provide quality leadership on complex issues (i.e., CHD) to Procurement/Outsourcing functions and PDQA staff
• Represent QA on Service Provider Strategic Alliance or Category Governance teams.
• Contribute to the development and execution of PDQA goals and initiatives
• Participate in or lead departmental or cross-functional compliance projects and initiatives as assigned
• Assists and/or contributes to the development and/or revision of PDQA SOPs, guidelines and tools
• Maintains knowledge of GLP, GCP, PV regulations and internal policies and SOPs  
• Maintains highest level of awareness and expertise in international GxP/PV regulatory requirements, guidelines, and policies, and applicable Roche/Service provider SOPs and project-specific procedures. 

...

HCV Sr. Clinical Coordinator
Territory: IL, MN, WI, ND, SD, and part of MI and KY. (Preferred location is Chicago; will consider Minneapolis) 

HCV Sr. Clinical Coordinators are responsible for the active promotion of Genentech's HCV product portfolio and focus their attention on key specialty customers and thought leaders. HCV Sr. Clinical Coordinators are expected to deliver on-label messages in support of product indications. HCV Sr. Clinical Coordinators implement programs and tools pertinent to the successful expansion of Genentech's HCV products in the treatment of HCV and other approved indications. The job requires an advanced level of technical and consultative selling skills. HCV Sr. Clinical Coordinators are preferably experienced working in a broad range of customer segments and in accordance with operational polices so as to appropriately influence current and future prescribers of Genentech products. The HCV Sr. Clinical Coordinator function is in a dual capacity through independent efforts and as a team player with the field and headquarters-based staff to ensure sound business strategies and services are being implemented. The HCV Sr. Clinical Coordinator must comply with all sales force promotional guidelines. 
...

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

 

Responsibilities:

 

- Provides Direction and Leadership to one or more SMTs

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

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

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

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

- Functions as Study Management Team Leader.

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

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

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

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

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

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

 

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

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

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

- Oversees the management of the Clinical Operations studies budget.

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

...

The Biomarker team in Early Development has an opening for a summer intern.

Responsibilities may include but are not limited to the following:

Evaluate and develop methods for capture and molecular characterization of circulating tumor cells (CTCs) . 

1- develop methods for identification of CTCs of epithelial and non-epithelial origin, and algorithms for automatic detection of CTCs.

2- evaluate diagnostic markers on CTCs using imaging methods (IF, ICC). 

3- develop methods to isolate single CTCs and evaluate downstream molecular analysis platforms.

...

An Associate Scientist position is available in the Protein Analytical Chemistry Department (within US Biologics Pharma Technical Development, PTDU).  The selected candidate will be responsible for developing, optimizing, and performing analytical methods to characterize recombinant protein therapeutics and antibody drug conjugates using techniques such as high-performance liquid chromatography (HPLC), mass spectrometry (MS), and capillary electrophoresis (CE).  This will include development, optimization and validation of analytical methods to be used for characterization and/or quality control of therapeutic protein and ADC candidates.  This individual will provide analytical support to different functional groups in PTDU and actively participate in project teams consisting of members from all areas of process development. This individual may be responsible for managing 1-2 research associates, depending on experience level.
...

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

...

Product Manager / Senior Product Manager

The Product Manager, Lytics Cathflo Marketing reports directly to the Group Product Manager and is responsible for:

Management of all peer-to-peer Cathflo programs including speaker's bureau, Cathflo Nurse Trainers, Cathflo Nurse Liaisons and national webinars.
Development of relevant medical education content and patient case studies for inclusion in peer-to-peer programs. Evaluation of nurse thought leader engagement strategy in partnership with the field and other internal partners.
Evaluating new means of marketing broadly to nurses, with a goal of driving an increase in habitual CVAD line assessment. Planning and execution of annual advisory boards in support of Cathflo, as needed. Contribution to the development and execution of the 3-year brand plan, and the 1 year tactical plan for Cathflo.

The successful candidate must have:

• Proven strategic agility in a complex marketplace
• Demonstrated experience in the development and execution of a sales or marketing plan
• Proven ability to partner effectively with field sales and sales leadership
• Considerable skill in influencing without authority
• Ability to provide rationale-based, succinct and persuasive oral & written communications
• Working knowledge of product development, regulatory and clinical affairs
• Demonstrated ability to establish thought leader and other relevant stakeholder relationships
• Strong analytical and project management skills, including previous experience working with budgets and analyzing market research results

...

Responsibilities: The successful candidate will participate in the discovery and investigation of novel small molecule drug targets in the therapeutic area of immunology.
Using state of the art techniques and technologies, he/she will investigate various signaling molecules, such as kinases, transcription factors, enzymes, and epigenetic regulators, and assess their potential therapeutic utility. Furthermore, the candidate is expected to independently design, execute, analyze and present experiments to various forums within and beyond the department of discovery immunology, and thus must have excellent communication and interaction skills.
...

We are seeking a highly motivated individuals to join the Oncology Biomarker Development Dept. to lead companion diagnostic (CDx) development programs in support of the Roche / Genentech early and late stage Oncology clinical development pipeline. The incumbent will provide leadership for a portfolio of molecules within a Franchise and represent these programs to senior management and decision-making bodies internally.

The CDx development strategies will be closely aligned with clinical development program timeline and strategy to enable robust clinical validation of the CDx, including establishment of thresholds and statistical analysis of the relationship with efficacy or safety using robust assays developed with diagnostic partners. The incumbent will also develop cross- functional relationships with internal scientific, operational and regulatory groups and diagnostic partners, and represent GNE / Roche CDx efforts to external professional organizations and regulatory bodies. The successful candidate will also be expected to contribute to Medical Affairs strategies to enable biomarker hypothesis testing.

 

Responsibilities

• Work closely with the biomarker, regulatory, statistics and clinical leadership to ensure development and effective operational execution of the CDx portfolio of multiple investigational agents in Franchises or Disease Area
• Management of direct and matrixed reports whose responsibilities will include programs in both early and late stage clinical development. A substantial focus will be in early development where design of CDx strategies that enable device development in preparation for hypothesis testing will be important. Therefore requires strong understanding and experience with development of diagnostic devices in order to develop fit for purpose CDx strategies.
• Develop and lead strategic initiatives to identify novel CDx technologies and develop relationships to enable effective evaluation of technologies as CDx assays.
• Develop and lead IVD strategies that are aligned with disease areas including development of multiplex platforms to support investigational and approved products in collaboration with diagnostic partners.
• Enable the coordination and execution of exploratory biomarker hypothesis testing in the clinic.
• Develop relationships with external key investigators, scientists and professional organisations in the diagnostic technology field to inform internal CDx strategies including next generation technology implementation and validation.
• Represent CDx strategy to health agencies as part of the regulatory strategies for the agents within the entire portfolio.

...

3 positions available for locations in SSF. Washington DC or Basel

 

Main Purpose of the Position:

·        Provides objective and uniform assessments of quality and compliance risks across global network, including independent expert review of (1) the internal GMP auditing program and (2) correspondence to global health authorities regarding GMP issues.

·        Supports support liaisons and interactions with external bodies and committees to influence on technical quality issues through articles, speeches and participation on committees

 

Job Duties/Responsibilities:

·        Performs independent expert assessment to determine global uniformity and conformance to appropriate regulatory standards for (1) internal GMP audits and (2) correspondence to global health authorities regarding GMP issues, including written responses to inspectional observations.

·        Advise senior management across PT Global network on best practices, regulatory intelligence, key opportunities, and possible threats in the areas of quality and compliance. 

·        Provides up to date regulatory and compliance information and trends, specializing in specific regulatory authorities and regions, providing timely information to the PTQ organization.

·        Contributes to expert GMP compliance opinions for PT Global network, including Manufacturing, Quality, and Regulatory Affairs.

·        Participates as a key member of teams throughout the global Technical Operations Quality organization for strategy and policy, external interactions and influencing activities as they relate to Quality and GMP/GDP Compliance

·        Supports the overall efforts for strong health authority relationships in the areas of Quality and Compliance through effective communications, interactions and participation in meetings, conferences and committees with focus on respective region or area of expertise.

...

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

...

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

...

We have an opening for a talented Scientist to join our Biochemical and Cellular Pharmacology Department. The successful candidate will be responsible for supporting mass spectrometric characterization of antibody therapeutics and antibody drug conjugates. More specifically, the individual will focus on developing, validating and executing various mass spectrometric assays to evaluate antibody therapeutics and antibody drug conjugates from both in vitro and in vivo studies to support lead-finding/optimization efforts in the context of multidisciplinary project teams. Working with automation and bio-informatics experts, the individual will be expected to implement robust and high throughput sample preparation as well as data analysis workflows for mass spectrometric assays. The candidate will have the opportunity to conduct detailed data analyses and will present these data to project teams and senior management. In addition, the candidate will function as part of a multi-disciplinary project team that will coordinate with protein science, chemistry, in vitro and in vivo groups to advance lead molecules of the projects....

This is a term position for approximately 9 months

Responsible for implementing and maintaining the validated state of automated systems at Genentech’s Oceanside Facility. Expected to be knowledgeable of and work within GMP regulations.  Requires protocol generation, execution, data analysis, troubleshooting skills, deviation investigation and protocol report closure for the site.  Responsible for validation contractor oversight, demonstrating leadership skills and modeling Genentech values and core competencies while working closely with Engineering, MSAT, Quality Assurance and Manufacturing.  This position requires strong communication and collaboration skills, the ability to work within teams, facilitate meetings and lead teams.  

Job Responsibilities

Essential

Manage and track the Validation program and assigned validation projects for automated systems and ensure target timelines are met and/or issues are communicated / escalated effectively and consistently.
Generate, review, approve and maintain Qualification Project Plans and Summary Reports and other validation lifecycle documents for automated systems.
Generate, review and approve a variety of Validation protocols (IQs, OQs, IOQs, PQs) for automated systems.
Manage protocol execution, perform data review and manage deviation resolution.
Oversight and management of validation contract resources including work prioritization, execution and contractor budget.
Strong understanding of commercial production environment and requirements.
Evaluate and audit the current validated status of automated systems.  Make suggestions for improvements as well as ensure system is operating in compliance and validated state.
Present validation packages for automated systems as required for audits and/or regulatory inspections.
Perform role of subject matter expert and assess change control and discrepancy events for automation systems.
Review automation validation lifecycle documents for compliance with CFRs, corporate requirements, and site procedures.
Lead group of Subject Matter Experts through the Quality Risk Management process and prepare Risk Management Reports documenting system risks, applicable remediation/risk reduction and critical controls.
Participate in cross-functional team meetings and where required, lead/facilitate meeting.
Review validation lifecycle documents for compliance with CFRs, corporate policies (QP/QS documents), and site procedures (SOP’s).
Participate in cross-functional team meetings and where required, lead/facilitate meeting.
Ensures there will be 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 their functional area.

...

Clinical Specialist, Tarceva/Zelboraf
Knoxville, TN or Asheville, NC

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

Reports to: Division Manager, Franchise Sales

Example Duties and Responsibilities:
*Responsible for meeting or exceeding assigned sales targets
*Develops robust territory business plans
*Develops strong and long-term relationships with customers in all assigned accounts
*Presents the assigned GNE brands in a professional, compliant, ethical and effective manner; helping external customers understand the benefits and use of GNE brands
*Monitors operating costs and compliance with territory budget
*Complies with all laws, regulations and policies that govern the conduct of GNE activities
*Business travel, by air or car, is regularly required
...

Solution Architect – Regulatory

 

The Regulatory team is looking for a highly skilled Solution Architect, able to deal with the multicultural team. We are looking for an outgoing and open minded individual with high communication and presentation skills.

 

The Position

 

The Regulatory Information Management (RIM) Solution Architect is responsible for the architecture of our RIM systems including Global Product Registration System (GPRS), Product Information Dissemination (PID), Q&A, XEVMPD, Protocol Reporting System (PRS) and RADAR, as well as a key contributor to develop these systems to a state where they fulfill the current business needs and are well prepared to meet future demands. 

 

The main responsibilities are:

• Working in a multinational team of employees
• Oversee the technical solutions
• Document the as-is architecture
• Develop the future-state architecture
• Develop a roadmap for the systems
• Support the ongoing projects and design solutions on the existing platform
• Providing guidance in area of expertise to Project Managers and Technical Leads

...

Group Product Manager, Erivedge Key Customer Team

The Group Product Manager (GPM) will report to the Erivedge Marketing Director. This position offers the opportunity to lead the brand analytics, access initiatives and key customer relationships for Erivedge, a first-in-class hedgehog pathway inhibitor indicated for the treatment of advanced basal cell carcinoma (aBCC). The role will be accountable for tracking performance indicators, implementation of access-to-care and practice management tactics and thought leader engagement, while leading a team of two marketers. Specific responsibilities include development of quarterly business reviews, thought leader development, advisory activities, peer-to-peer promotions, managed care / access programs and providing appropriate commercial perspective to publication planning and medical teams.

Additional responsibilities of this position include: 

• Collaborate with MCCO to ensure understanding and execution of brand strategies within appropriate payer and field-based tactics
• Lead initiatives with MCCO to optimize patient flow from script to shipment 

• Manage development and implementation of thought leader strategies including major conference activities, internal management tools, and participation/involvement in key promotional activities
• Collaborate with field sales, TLLs, marketing colleagues on thought leader activities
• Collaborate with BioOncology partners for implementation of major meeting activities

• Collaborate with Medical Affairs, Clinical Science, and Advisory Board Services to manager advisor activities
• Lead data integration team toward developing and tracking key performance metrics in collaboration with market planning, marketing science, sales operations and forecasting/business analytics team
• Lead and motivate team of two direct reports and manage all activities and professional development
• Managing brand budgets 
• Maintain strong relationships with colleagues in research, clinical, medical affairs
• Actively participate in Oral Oncolytics and BioOncology initiatives and programs
• Comply with all laws, regulations and policies that govern the conduct of GNE activities

Successful candidate should possess:

- Solid understanding of specialty biotech/pharmaceutical marketing and sales

- Solid experience with proven results in managing and motivating direct reports in a marketing role 

- Strong analytical and communication skills

- Direct experience managing through leader relationships and/or extensive knowledge access dynamics for part D drugs

- Proven ability to develop relationships with sales force and across departments for support of strategies 

- Proven ability to work in a fast-paced, collaborative environment which requires significant cross-functional and cross-brand coordination and teamwork

- Proven ability to work in teams and also work autonomously 

- Experience in working with commercial promotional review committees

- Proven track record of adhering to timelines and budgets

...

Brand Protection is a proactive initiative to protect patient safety, supply chain integrity and brand reputation by identifying and acting on individuals or entities that intend to mislead healthcare practitioners, caregivers, patients, trade organizations or the public at large for their own illegal gain.    

The Senior Manager, Brand Protection reports directly to the Director, Interactive Marketing and is responsible for overseeing the Brand Protection Core Team, managing key external partnerships, directing ongoing surveillance, executing the communication strategies, analyzing the impact of these entities and reporting initiative progress to Commercial leadership.

MAJOR RESPONSIBILITIES:

• Direct online and offline monitoring of suspect products, diversion, trademark infringement, and promotional abuse in the US market, maintain expert familiarity with core industry trends, including customer, competitive and enforcement dynamics in order to adapt and support various aspects of Brand Protection.
• Serve as the single point of contact for orchestrating Brand Protection activities across the Commercial organization.
• Leads a multidisciplinary, cross-functional Brand Protection Core Team that includes Quality, Trade, Security, Commercial Law, Patent Counsel and Customer Operations. 
• Leads the development of a communication plan that keeps both the CLC and the Commercial organization at large appropriately informed of Brand Protection initiatives and progress reports.
• Track online pharmacies selling Genentech products illegally and analyze behaviors relative to Rx requirements, trademark/copyright infringements, product format/packaging and pricing.
• Execute monthly communication strategies (warning letters) and track response to key actions.
• Prioritize monthly targets for suspect product purchase, secure senior management approvals, and oversee the purchase process. 
• Build and manage relationships with key Federal Enforcement Agencies  (FDA OCI, ICE, DOJ) and partner organizations (NABP, PSI, CDC).
• Develop and manage budgets/resource requests for all Brand Protection activities. 
• Serves as a member of the Counterfeit Core Team.

CAPABILITIES:

• Strong leadership presence with proven ability to influence stakeholders at various levels of the organization (both US and Global); capacity to work collaboratively with peers in pharmaceutical industry and engage support/ alignment.
• Ability to build, lead, motivate and represent matrix, cross-functional teams without direct reporting authority.  
• Superior verbal/ written communication abilities with demonstrated success at communicating complex situations and action plans in a simple, structured and easily absorbed manner.
• Willing to champion new ideas or positions to meet key goals and doesn’t abdicate responsibilities.  Can negotiate skillfully in tough situations with both internal and external; U.S. and Global groups.  Is comfortable around, and influential with, higher management.
• Experience in forecasting and building predictive models to understand impact of diversion on legitimate trade channels.
• Basic understanding of online promotional practices, search engine marketing and social media environments.  Understands consumer behavior and response dynamics.
• Strong commitment to patient safety and compliance requirements.  Maintain thorough understanding of U.S. compliance requirements and legitimate channel definitions.

...