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

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The Department is currently seeking an additional Pathologist to work with five of its Pathologists to help them support (i) research scientists who discover and develop drugs for the treatment of cancer, and (ii) research scientists and clinicians who discover and develop biomarkers for pharmacodynamics and patient selection purposes in Phase I, II and III clinical trials of oncology therapeutics.

The successful candidate will be familiar with, if not expert in, the molecular, cellular, systems biology, and pathogenic mechanisms of cancer. He/she will have a strong interest in providing pathology support for drug and biomarker discovery programs in cancer, and an appreciation for the need for potential flexibility in contributing support to programs outside of oncology as the need arises.  Depending on the candidate and the availability of resources, there may be an opportunity for the individual to spend part of his or her efforts in basic and/or translational research activities that have relevance to the company’s business goals.

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The DMPK group is dedicated to enabling the discovery,development and commercialization of safe and effective medicines by elucidatingthe absorption, distribution, metabolism, excretion and pharmacokineticproperties of small molecule drug candidates. We accomplish this through theapplication of state of the art technologies and sciences of bioanalysis, drugmetabolism, drug transport and pharmacokinetics. The DMPK group works in closepartnership with disciplines such as medicinal chemistry, pharmacology,toxicology, pharmaceutical sciences, clinical pharmacology and regulatory tooptimize leads, select clinical candidates, conduct preclinical developmentstudies, support clinical evaluation and contribute to IND and NDA filings.

We are seeking a Senior ResearchAssociate/Research Associate to support Small Molecule Drug Discovery in theDrug Metabolism and Pharmacokinetics (DMPK) department.  The qualified candidate will work closely withour established team performing metabolic stability assays using hepatocytesisolated from various species, protein binding experiments in plasma, tissues,and microsomes from various species, and hypothesis-based in vitro metabolismassays to address specific mechanistic questions in drug discovery.  This person will perform weekly, fullyautomated, high-throughput, and high-capacity in vitro experiments to supportsmall molecule projects.  This personwill develop analytical methods (LC and MS/MS) to separate and detect smallmolecules and also proficient in using and troubleshooting LC-MS/MS.

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The successful candidate will be involved in late-stage pharmaceutical development ofmonoclonal antibodies, antibody-drug conjugates, and delivery systems for clinical evaluation and commercialization. The responsibilities of this role include formulation development, evaluating product stability and throughout the manufacturing process and performance in diverse delivery systems, as well as biophysical characterization, drafting technical documents and contributions to regulatory filings. Applicants should be comfortable working both independently with minimal supervision and as part of a team to support the development of recombinant protein therapeutics. The successful candidate will also be expected to participate on cross-functional project teams. The position offers opportunities for professional and scientific growth in a dynamic, intellectually stimulating and fast-paced work environment.

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A Research Associate/Senior Research Associate 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).  The individual will maintain excellent documentation of all work including laboratory notebooks, test methods, or any other appropriate documents.  Additionally, the individual will be responsible for presenting results and experimental information to departmental colleagues, writing and reviewing internal reports, and representing the department on project teams consisting of members from all areas of process development.
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Position Description and Responsibilities:

A Research Associate/Senior Research Associate 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).  The individual will maintain excellent documentation of all work including laboratory notebooks, test methods, or any other appropriate documents.  Additionally, the individual will be responsible for presenting results and experimental information to departmental colleagues, writing and reviewing internal reports, and representing the department on project teams consisting of members from all areas of process development.

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We are seeking an outstanding individual for theposition of a Research Associate / Senior Research Associate within theBiochemical and Cellular Pharmacology department. The successful candidate willbe responsible for supporting research projects in the disease therapeuticareas of immunology and/or immunotherapy as part of the biologics drugdiscovery program at our South San Francisco campus. The individual will be expectedto work independently in developing and performing immunochemical, biochemical,and cell-based assays to support candidate selection, potency, efficacy, andpharmacokinetic studies as well as immunogenicity evaluation andpharmacodynamic biomarker measurements. In addition, the individual will incorporateautomation into his/her daily work and apply novel technologies in assaydevelopment.

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The In Vivo Studies group is seeking a team-oriented, highly motivated individual to participate in the technical conduct of in vivo studies in a high-throughput work environment. This unit of the Safety Assessment Department is responsible for the planning and execution of pre-clinical drug development studies (including pharmacokinetics and toxicology) supporting a large customer base.

Responsibilities:
Studies include (but are not limited to) work with chemotherapeutics, radioisotopes and other potentially hazardous materials. The individual will have to perform applicable techniques requiring a high-degree of manual dexterity (cannula implantation, catheter insertion, drug administration, blood collection, restraint, anesthesia, euthanasia) in common in vivo models. Maintain study-related documents and follow departmental SOPs to ensure study integrity and quality. Assume role of study coordinator for selected studies and write preclinical protocols as appropriate. This job will involve a high level of physical activity.
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The job responsibility within the Biological Technologies group in Analytical Development and Quality Control, is to develop, qualify/validate, and troubleshoot biochemical/immunochemical and cell-based assays for clinical and to-be-marketed products.  The candidate will perform testing as needed in support of process development, stability, and lot release according to established test procedures..  Expectations will also include some routine lab maintenance, participate in writing SOPs, test procedures, and participate in training, performing testing, troubleshooting, and/or validation of immunological and cell-based potency methods.  Additional responsibilities may include presentation of data at internal meetings and participating in the evaluation of new equipment and technologies. ...

The candidate will be working in the design, performance and analysis of virus clearance studies, evaluating virus removal by protein recovery processes. Candidate will execute chromatography and/or filtration processes and perform Q-PCR, or cell-based, assays. Candidate will be responsible for scaled-down chromatography and filtration of the recovery process, as well as virus nucleic acid purification and quantification. Candidate will write GMP protocols, summary reports and execute validation studies. Depending on the business needs, candidate will support the development and implementation of recombinant protein purification process from laboratory to manufacturing scale.  The work may include purification process development, optimization, characterization, and validation. The work includes projects carried out at laboratory, pilot plant, and industrial scale using separation unit operations including column chromatography, filtration, and centrifugation. The successful candidate will also collaborate with many different functional groups and work on the development of state-of-the-art technology on viral clearance or protein purification.

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Description
The Critical Reagents System (CritRS) in Purification Development is responsible for the purification of critical reagents in support of assay development (for clinical products), assays in support of regulatory filings, the continued support of assays for marketed products, as well as specific reagents that support general test procedures (such as ELISAs to measure host cell impurities).  The candidate will be responsible for protein purification, characterization, and documentation of critical reagent production within the purification group. The work also includes interaction and collaboration with members of other CritRS production and customer groups, and potential support of other projects within the group.

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GENERAL POSITION SUMMARY/PURPOSE:¿

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 Managers are assigned their responsibilities by therapeutic area, and are assigned projects for different product development phases, as business needs dictate. Regulatory Program Management Program Managers support regulatory program management for one or more development projects. Regulatory Program Management Program Managers participate in and support the development and implementation of regulatory strategies to facilitate the development and approval of Roche medicines for human use. Program Managers are expected to perform their responsibilities with supervision. Regulatory Program Management Program Managers work cross-functionally and help coordinate regulatory-related activities across PDR functions and with other internal partners.

JOB DESCRIPTION – PRIMARY DUTIES AND RESPONSIBILITIES:

1. Intact & Cross-Functional Teams

• Participates in site and/or regional and/or global PDR Program Management departmental meetings
• Participates as a standing member in the Regulatory Affairs Functional Team (RAFT) for assigned product development projects to help ensure effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough ¿and compliant execution
• As assigned or otherwise needed, assists relevant Regulatory Program Management Program Directors with their interactions, ¿communications and planning with various other teams, dependent upon assigned projects and the associated development phase, such as early development core teams, global development teams and lifecycle teams. Helps Regulatory Program Management Program Directors coordinate cross-functional PDR contributions to product development projects and other related activities
• As assigned, may act as a standing or ad hoc member of other teams for special or ongoing initiatives and projects

2. Regulatory Program Management

• 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 assigned therapeutic areas and projects. 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
• Stays abreast of therapeutic area product development and other related business strategies and plans
• Supports on one or more regional projects at any one point in time 
• Analyzes data, the regulatory environment and business objectives to advise others on applicability of new or existing regulations and guidelines
• Participates in the development and implementation of the cross-functional regulatory strategy for each project or related assignment
• Supports Regulatory Program Management Program Directors in identifying and aligning cross-functional regulatory resources necessary to execute the regulatory strategy for each project or related assignment
• Supports Regulatory Program Management Program Directors and others in preparing and facilitating meetings, teleconferences and other interactions/communications with regulatory authorities. Establishes effective working relationships internally and externally with regulatory authorities
• Documents meetings, teleconferences and other interactions/communications with regulatory authorities
• Supports Regulatory Program Management Program Directors in providing internal teams with direction on regulatory authority ¿interactions
• Participates in and supports management of ongoing RAFT meetings. Including providing ongoing guidance on regulatory ¿deliverables, compliance, timing and other relevant matters. Helps manage RAFT resources, including documenting meeting ¿minutes and conducting follow-up to ensure action items are completed in a timely and thorough manner
• Helps manage project plan...

The Regulatory Advisor will be responsible for developing global regulatory strategy, writing high quality dossier and leading teams for assigned projects to obtain timely approvals of Roche applications. The Roche Pharma Technical Regulatory leadership team is composed of seasoned technical experts whose focus is to collaborate with Roche Scientists and International Health Authorities to drive development of innovative regulatory policy, and ensure the approval of Roche products developed using novel and efficient process development strategies. This position will require regular interaction with management from multiple internal functional areas, corporate partners, international regulators and external experts.

 

The individual will lead and/or participate in cross-functional project teams and work effectively with multiple disciplines and personalities.  The candidate will support both US ex-US filings, as appropriate and as requested by corporate partners.  Additional responsibilities will include leading departmental operational excellence and business process initiatives, as well as, proactively communicate with Regulatory and cross functional personnel and partners in support of internal and partner associated goals.

The Regulatory Advisor 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. Have a proven ability to work well under pressure.  The incumbent will be skilled to lead communications with FDA and regulatory agencies to facilitate review and approval of submissions.

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Department:                       Pharma Technical Regulatory (PTR)

 

Job Family / Category:      PTR Regional Hubs

 

Position:                             PTR Regional Hub Sr. Regulatory Associate

                                           PTR Regional Hub Regulatory Manager

 

Location:                           Tuas, Singapore

 

Purpose

 

This position will be responsible for execution and management of regional life-cycle submissions for all Roche products as well as new product registrations by focusing on local needs of Affiliate Drug Regulatory Affairs (DRA) teams to ensure right first-time submissions to Health Authorities.

 

Responsibilities:

 

* The incumbent will be the primary technical regulatory (CMC) point of contact for the Affiliate DRAs and as such he/she will work closely with them and the regional Supply Chain teams as well as with the PTR product managers and the PTR network.

* In coordination with global PTR Technical Regulatory Leaders (TRL), execute regulatory strategy for lifecycle submissions in Asia Pacific markets associated to management of CMC changes originating at manufacturing sites or affiliates toward maximizing efficiency, quality and rate of submission approvals by Health Authorities.

* Coordinate strategic planning with Regional Supply Chain and Affiliates DRA for change management alignment and early visibility/communication/planning of changes impacting markets in the region.

* Assemble lifecycle submissions for markets under responsibility to guarantee right first time submissions and coordinate/manage with affiliates for timely and effective submission of changes to the Health Authorities.

* Act as subject matter expert in regulatory requirements for post approval submissions and maintain the regulatory intelligence repository for regional markets under responsibility.

* Ensure timely update of the CMC change management electronic systems with the regulatory information submitted/approved externally by a Health Authority or internally by the appropriate functional area.

* Upon request, support Affiliate DRA with interactions with regulatory authorities to facilitate the prompt review and approval of submissions (CMC content Subject Matter Expert).

* Manage timely responses to Health Authority questions resulting from lifecycle submissions in regional markets under responsibility.

* Manage tracking of commitments with a Health Authority as result of license/dossier approval and ensure commitments due dates are met.

* The candidate may be required to travel to other Roche sites on a periodic basis.

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Description - 

An opportunity for a protein biochemist is available to join a chemical biology group in the Department of Early Discovery Biochemistry. The group uses a multidisciplinary molecular approach for target validation. Recent efforts focus on the use of peptide phage display and small molecule tools for modulating protein-protein interactions and fluorescence imaging of cellular proteins. The successful candidate will be responsible for producing proteins and peptides of therapeutic interest and their characterization by analytical methods (affinity purification, RP-HPLC, SDS-PAGE and western analysis). He/she will also investigate the functional mechanism of bioactive ligands by biochemical and cellular assays. This is a basic research position that requires critical thinking, flexibility, multitasking and the ability to learn new techniques.

 

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The Quality Product Leader is part of Clinical (IMP) QA.  This position will be responsible for managing the quality logistics for commercial product used in clinical trials across the network. The job responsibilities include creating and implementing business processes to effectively manage the logistics for small and large molecule active, placebo, and comparators; both product produced by Roche and by a competitor.  The position is global.  This position will establish and maintain strong partnerships with internal and external colleagues, customers, and stake-holders.  These groups are located globally and are comprised of, but not limited to, QA Operations, Commercial Product Quality Stewards, External and Site Quality, Commercial QC, Product Development, Global Supply Chain, Country Qualified Persons and Pharma Technical Regulatory (PTR).

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Description Main Purpose of the Position:

• Direct Quality support staff and operations in accordance with cGMP regulations and Roche standards.
• Provide leadership and guidance to immediate staff hosting inspections or performing Quality Systems functions as assigned.
• Provide the Director, GQIM, with expertise in device and/or combination product inspection issues and risks.

Job Duties/Responsibilities:

• Optimize resources with the PTQS department.
• Interpret, execute and recommend improvements to Quality operational policies, plans and procedures.
• Provide input to department budget.
• Monitor and control expenditures against the department budget.
• Provide input for the development of overall Quality objectives and long-range goals.
• Notify Senior Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
• Lead and participate in continuous improvement initiatives for Roche Quality Systems.
• Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
• Be accountable for behaviors described in Core, Common and Critical Competencies.
• Perform any other tasks as requested by Senior Management to support Quality oversight activities. Technical

Duties/Responsibilities:

• Develop and oversee implementation of the Inspection Risk and Readiness systems to ensure on-going inspection readiness.
• Collaborate with Pharma Technical Operations and Quality areas as needed to identify inspection risks and mitigation plans.
• Serve as a GQIM primary point of contact and liaison for assigned sites
• Manage and oversee the inspection readiness program across sites to ensure proper deployment and reporting of inspection risks
• Lead or support regulatory inspections as appropriate.
• Collaborate with sites to develop and communicate inspection strategy, approach and goals.
• Communicate potential inspection risks and current state of inspection readiness to Senior Management.
• Provide input into the design and presentation of inspection readiness performance metrics
• Act as an advisor to internal project teams by providing extensive knowledge of regulatory requirements, industry standards, and company strategy.
• Attend and participate in external regulatory and/or compliance organizations, and applicable industry conferences to exchange information regarding current regulatory inspections and to stay current on inspection trends.

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Here is an opportunity to join Roche as a Quality Manager. This position is responsible for proactively ensuring that all GCP governed clinical activities within the department (PDG – Operations) are delivered to the highest standards of quality and efficiency in accordance with the appropriate Roche and industry requirements and regulations.

The Quality Manager promotes quality and compliance excellence within PDG Operations by embedding quality principles throughout the organization. This is achieved through:

• Close collaboration/partnership with the Product Development operational staff
• Facilitation of subject matter experts within and outside PDG
• Close liaison with PDQ (global quality group)

Main Responsibilities:
Quality Management System (QMS) – You will be required to understand and maintain the QMS requirements for the business and develop and implement the QMS and monitor its performance.

Ensure cross functional alignment and compliance through process documents -  By analyzing/reviewing  “to be” processed, forms, templates and related process documents and facilitate review and approval of process documents along with global and cross functional teams. The Quality Manager will coordinate the functional subject matter experts by scheduling review and implementation of new/revised process documents.

Risk management strategy - Ensure strategic quality risk management activities are implemented and maintained and enable identification of key risks for escalation to study teams and senior management.

Performance metrics - Develop and implement the most appropriate key performance indicators (KPIs) for the business and monitor their effectiveness and gather and report on the metrics which give performance data on the chosen KPIs.

Compliance support - Provide timely GCP compliance support to personnel by answering questions and providing advice and facilitate escalation of compliance issues through the appropriate routes and with appropriate urgency.

Additional duties include:

• Continuous Improvement
• Training Compliance
• Facilitation of simple aligned business processes
• Inspection Readiness and supporting Sponsor inspections
• Records compliance

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• Perform testing of routine and non-routine samples and document according to GMP.
• Perform environmental monitoring and utilities sampling and document according to GMP.
• Review data and assess against established acceptance criteria.
• Perform technical review of peer-generated data for basic methods.
• Prepare data tables and graphs.
• Identify discrepancies, participate in quality investigations and CAPA (corrective actions preventive actions) initiatives as needed.
• Receive and provide training.
• Participate in assay transfer and assay validation as needed.
• Perform equipment qualification / maintenance.
• Prepare and maintain standards, controls, stocks, and cultures per established procedures
• Support the maintenance and compliance of operational areas.
• Assure and apply GMP throughout operations.
• Coordinate with supplier/customers to support operational activities.
• Support internal and external audits.
• Work to meet schedules.
• Identify and support resolution of technical problems. Resolve sample issues as needed.
• Actively participate in group and project teamwork; projects and process improvements.
• Draft protocols and reports under supervision.
• Meets scheduled performance of 95% on time (ATS).
• Perform other duties as requested by managers to support Quality activities.

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