Senior Clinical Programmer Analyst (19-01050) – NJ – Woodcliff Lake

Perform SAS programming to provide complex data review listings/reports to support different functional groups for Oncology trials.
Program data review checks as necessary to facilitate data cleaning activities.
Design standard programs and macros using study metadata.
Design and develop SAS macros, applications, and other tools to expedite SAS programming activities to support different areas of Clinical data review.
Develop standard SAS utility macros for developing standard programs. Develop and maintain the programs including testing and organizing the SAS datasets, SAS programs and related documentation.
Ensure all programming activities and processes are performed following standard operating procedures and good programming practices.
Participate in system validation, customization, and integration of new tools and technologies.

Qualification:
Strong SAS programming skills required in Windows & UNIX environment with proficiency in SAS/Base, SAS Macros, SAS/Graph, SAS/SQL.
Experience in writing SAS tools and developing generic SAS programs for clinical studies
Knowledge of working in SAS Grid environment with experience in SAS Enterprise Guide, SAS Data Integration Studio, SAS Studio is a plus
Good understanding of relational databases such as ORACLE, Knowledge of the EDC system, InForm, and underlying data structure is desirable.

Additional experience:
Good understanding of system development life cycles, GCP, and related regulatory guidelines.
7-10 years of experience in programming with clinical trial data and preparing programming and test documentation.
Experience with all clinical phases I, II, III and IV of oncology trails is desirable.
Good understanding of Recist, mRecist, irRecist and Rano criteria.
Extensive experience of handling external data, such as lab data, PK,Tumor,Biomarker,Imaging etc.
Good understanding of standards specific to clinical trials such as CDISC, SDTM, MedDRA, WHODRUG.
Good understanding of Regulatory requirements for submissions to FDA, PMDA and EMA.

Strong problem solving skills
Able to work independently and a team player, good organizational and time management skills.
Excellent communication skills & capable of communicating technical concepts
Excellent organizational skills, demonstrated success to multi-task and deliver viable solutions in a fast-paced environment with changing priorities.
Source: Job Diva – Job Listing

Technical Project Manager (Biostatistics) (19-01049) – NJ – Berkeley heights

 General Summary:
The Technical Project Manager, Biometrics and Medical Writing, is responsible for supporting
cross-functional leadership in Biometrics (Data Management, Biostatistics, and Statistical
Programming) and Medical Writing in project execution and providing timely, high quality
deliverables. This position provides project management support related to development and
execution of product programs, including, but not limited to, regulatory submissions activities.
The incumbent works closely with Biometrics and Medical Writing leadership and personnel, as
well as other functions (such as project management, clinical operations, regulatory, commercial
and health outcomes activities) and vendor representatives from corresponding functions.
Establishes, monitors, and communicates achievement of milestones on time and within budget.

Major Responsibilities:

  • Works with submission team to provide support for planned regulatory submissions.
  • Closely monitors internal and external deliverables, maintaining function-specifictimelines and communicating updates to key stakeholders
  • Manages receipt of biometrics deliverables from vendors and establishes process and tools for dissemination of information to key internal and external stakeholders.
  • Works within cross-functional groups with the execution of product development plans and operations to ensure continuity across the development lifecycle.
  • Leads the proper identification, integration and allocation of resources across multiple development efforts operating concurrently.
  • Optimizes resources while avoiding critical resource bottlenecks that impede progress against time.
  • Manages departmental and project budget to ensure planning and spending is consistent with established corporate operating expense goals.
  • Other responsibilities as assigned.
Knowledge and Skill Requirements:
  • BS/MS in scientific or mathematics related field
  • Experience in Product Development and Project Management with at least 5 years of experience in biopharmaceutical industry; direct experience in Data Management,
  • Biostatistics, SAS Programming and/or Medical Writing a plus.
  • In-depth experience in Finance, Clinical Development and Program Management operations; alliance management a plus.
  • Strong leadership and communication skills mandatory.
  • Demonstrated skill in strategic planning and operational excellence.
  • Ability to collaborate cross-functionally with individuals in a wide variety of disciplines
  • Demonstrated ability to mentor individuals in leading, as well as functioning in a cross-and backgrounds and build strategic relationships.
  • functional environment.

Source: Job Diva – Job Listing

Business Systems Analyst IV (19-01048) – CA – South San Francisco

Business Analyst

The Position
The IT Business Analyst will be responsible for working closely with partners across lines of business and the IT group in order to understand current system landscape, strategic drivers, tactical needs to participate in the system landscape documentation exercise, and to ensure that the implementation teams can provide solutions that meet the business need with the necessary stability, usability, and scalability.
Duties:

  • Analyzes business scenarios and identifies opportunities for improvement through automation and/or business process change.
  • Provides analytical expertise in identifying, evaluating, designing and developing systems and procedures that are cost effective and meet user requirements through interviewing and conducting workshops.
  • Documents and champions business processes and priorities.
  • Elicits, organizes, analyzes, translates, drives out ambiguity and simplifies requirements.
  • Manages documents and communicates requirements.
  • Derives functional specifications, user interface and/or technical specifications.
  • Develops mock-ups and prototypes, communicates during the requirements lifecycle using demos.
  • Adjudicates solution’s adherence to requirements during testing and defect triage.
  • Knowledgeable in testing best practice, and supports systems quality assurance.
  • Facilitates and supports system and user acceptance testing.
  • Develops business cases in collaboration with business stakeholders and key account managers.
  • Provides consultation to users in the area of business systems and processes.
  • Leads cross-functional discussions in the resolution of business or systems issues.
  • Champions accountability by example.
  • Participates in roadmap discussions and vendor assessments.

For this position you will bring the following qualifications:

  • Bachelor’s degree or equivalent experience in business administration, computer science, systems design, or equivalent field with 5 years + experience in analyzing business processes, business requirements and in supporting information systems projects.
  • Demonstrated excellence in analysis, documentation, facilitation and presentation skills.
  • Strong skills in leadership, critical thinking, structuring, communication across a wide range of management levels and facilitation of small and large groups.
  • Understanding of systems engineering concepts.
  • Experience with modelling techniques, methods and tools e.g. use cases, activity diagram, flow chart, UML, Stories, prototyping etc.
  • Demonstrated ability to conduct cost/benefit analysis and business case development.
  • Demonstrated success handling global initiatives of high complexity and risk.
  • Experience with life sciences industry, medical and scientific affairs processes and in delivering technical solutions for clinical operations, business development and data integration
  • Experience and knowledge of processes and procedures for validated systems and CSV.
  • Fluent English skills

Location: South San Francisco
Source: Job Diva – Job Listing

Clinical Data Associate III -: Data Science & Informatics (19-01046) – MA – Cambridge

Duties:

  • Collaborates with the project team to help gather technical requirements.
  • Creates and maintains the following documents for the Rare Disease Registry web-based EDC and reporting technology platform: eCRF database specifications, data validation (edit checks) specifications, report specifications, and other functional specifications.
  • Provides peer review/QC of technical specifications/documentation to ensure consistency and accuracy
  • Collaborates with the technical vendor and data management team to troubleshoot database bugs/issues from root cause to resolution.
  • Develops training materials and provides training on technical applications to data management peers and Site Operations personnel.
  • Collaborates with the Data Management team to define and develop operational reports to assist with data exploration and metrics.
  • Collaborates with the Data Management team in the development of global, inter-departmental harmonized SOPs, and registry specific guidelines.

Required Skills:

  • Clinical data management experience (CRF design, data collection, data review, query management)
  • Experience with EDC systems
  • Clinical database experience including eCRF/database design and development, system edit check design and development, writing UAT scripts, and conducting UAT
  • Good working knowledge of software development life cycle (SDLC) and change management
  • Good working knowledge of industry data standards (e.g., CDASH, SDTM) and how to apply them to CRF design and database development
  • Ability to work with reporting/analytical tools (e.g., Business Objects) to manipulate data and produce metrics
  • Good working knowledge of International Regulations / Guidelines / Good Clinical Practices pertaining to the pharmaceutical industry standards and practices

 
Formal Education and Experience Required:

  • Bachelor’s degree in related science/technical discipline
  • At least 4years of clinical data management/database development experience in the pharmaceutical/biotechnology industry
  • At least 2 years of experience with EDC systems, preferably Medidata Rave
  • At least 2 years of experience with EDC requirements, database development, user acceptance testing, and implementation of eCRF study builds

Knowledge and Skills Desirable:
•             Experience with Medidata Rave EDC
•             Completion of Medidata Rave Study Design and Build Essentials training coursework
•             Experience with CRF migrations within EDC systems
•             Experience with validation of computer systems
 
 
Source: Job Diva – Job Listing

Clinical Contract Coordinator II Glob Corp Purchasing (19-01045) – NJ – Bridgewater

This position is a key role in executing and maximizing the efficiency of the contracting process. The individual must understand business requirements, complex policies, and have the ability to assess risk in review of spend transactions. The individuals will process and draft contracts according to legal and compliance standards for the agreements delegated by the legal organization. These individuals will work closely with the Business/End Users, Procurement, Legal and PTP team members to ensure an efficient and timely contract execution. Must have at least 3 – 6 years of experience.

Facilitates and ensures completion of the contract preparation process starting with contract draft and continuing through to approvals, contract signature, and storage.
Drives, monitors and proactively follows up on the approval of contracts through the appropriate system/approval flows to assure they meet customer timing requirements.
Manages documentation and related processes in appropriate contracting and procurement systems.
Ensure correct information is included with transaction to improve overall efficiency of processing with specific attention to reduce errors that cause invoice challenges.
Drafts delegated agreements in accordance with Legal approved templates
Determines need for additional contractual provisions based on ***-specific Compliance requirements (e.g. Covered Persons).
Proactively organize and manage Queue of open contracts related to the business function supported
Independently reviews and applies judgment to determine appropriate spend strategy of transactions (contracts and purchase requisitions) in accordance with company policies and guidelines from Procurement and Legal.
Initiates the contract creation process once the supplier has been selected
Selects template (if provided and trained by legal) and completes initial draft of contract with input from requestor, supplier and buyer
Negotiates certain pre-identified clauses, under the guidance of Legal
Accountable to provide status updates with clear communication with requesters and support functions
Acts as single point of contact for all contracting stakeholders (Requestor, Legal, Finance)
Initiate and coordinate legal participation in complex contract drafting and review process
Works with legal to coordinate additional input or modifications (as needed) from supplier based on review process
Coordinate and Chair regular meetings with contracting stakeholders in legal, business, and procurement to discuss open contracts including prioritization, open items, contract pipeline, and continuous improvement opportunities
Escalate opportunities for continuous improvement and ongoing training/capability opportunities for contract administrators and trained users
Implement continuous improvement practices to assess and evaluate efficiency of contract management
Act as single point of contact for any questions related to the end to end contracting process within business area of support.
Support onboarding or training for new contract administrators
Review contract requests for completeness prior to preparing, drafting and processing
Contribute to the development and / enhancement of guidelines and SOPs.
Maintain level of performance and quality in alignment with departmental SLAs and SOPs
Responsible for understanding complex compliance policies and ensuring the requirements are met and properly supported
Accountable for triage and resolution of issues with internal customers, acts as a liaison for escalations to maintain a high-level of customer satisfaction.
Provide subject matter expertise and guidance for procure to pay process and suite of tools ensuring high customer satisfaction.
Perform key SOX controls (including screening of contracted parties, review Contract Approval Policy, Delegation of Authority of contract signatories and compliance with records retention policies), and support compliance with CIA as needed via either process or system
Source: Job Diva – Job Listing

Drug Safety Specialist II (Risk Benefit & Epidemiology) (19-01041) – NJ – Bridgewater

JOB SUMMARY
 
The Benefit-Risk support will support Benefit-Risk evaluation team to lead the development of the B/R models, propose the appropriate the most efficient and comprehensive approach, methodology, and tool for the B/R evaluation and guide the team of stakeholders contributing to the structured B/R assessment.
 
KNOWLEDGE, SKILL, FORMAL EDUCATION & EXPERIENCE REQUIREMENTS
 
Knowledge And Skills

  • In depth knowledge of B/R methods and extensive experience B/R and in different B/R tools.
  • In depth knowledge of Real World Data sources and epidemiology or other RWD-related quantitative methods and extensive experience in RWE analytics.
  • Proven capability to clearly visualize and communicate complex quantitative models and issues to both the scientific community and the general public.
  • Written and verbal communication proficiency in English, including the presentation of data.
  • Demonstrated ability to formulate investigational plan and capability to work in crisis situations.
  • Excellent teamwork and interpersonal skills and proven time management skills.

 

Formal Education And Experience Required:
  • PhD degree or other advanced Science degree from an accredited graduate department of epidemiology or other public health related fields
  • or
  • MD degree/pharmD degree/DVM degree with graduate training in Epidemiology or other public health fields.
  • Significant experience in clinical and/or epidemiological research and quantitative B/R assessment in industry (or equivalent experience in academic setting).

Source: Job Diva – Job Listing

Associate Research Scientist I (19-01039) – MA – Cambridge

Work independently in supporting senior fellow in biopharmaceutics evaluations. Design, plan, and perform analytical experiments in order to test hypotheses and advance understanding of fundamental scientific principles. Interpret and report results.
With minimal oversight from senior fellow, design and perform analytical scientific experiments.
Standard and Client solubility and dissolution experiments of drug substance and drug product.
Analysis by Fiber Optic techniques and UPLC/MS. Experience with quantitative UPLC/MS analysis of samples is necessary.
Interpret results, evaluate data, draw relevant conclusions, and capture all experimental data in electronic laboratory notebook according to *** electronic documentation process.
Report and present results internally and contribute to publications and presentations if applicable.
Utilize complex tools and equipment, lab automation tools and specialized facilities.
Empower Chromatography software, Acquity UPLC, HPLC, QDa detectors, fiber optic systems and dissolution baths. Experience with solid powder handling equipment and automation is preferred.
Electronic laboratory notebook (Cambridgesoft eLN) and ChemDraw
Maintain infrastructure and equipment and required investments.
Proactively communicate key issues and any other critical topics in a timely manner to the appropriate management level and/or to any other relevant project team members.
Work according to appropriate SOP’s, HSE and *** guidelines. Maintain a clean and safe working space.
Keep track of lab supplies and submit orders to ensure proper availability so as not to delay any planned experiments. Plan work and complete in a timely manner.

Proficient in English (oral and written)
1. Knowledge of laboratory and technical tools.
2. Proficient in utilization of special tools and equipment, lab automation tools and specialized facilities e.g. analytical tools such as UPLC.
3. Good knowledge of software and computer tools.
4. Literature search skills.
5. Very good communication skills. Good presentation skills and scientific/technical writing skills.
Source: Job Diva – Job Listing

Operations Manager III (19-01037) – CA – South San Francisco

Informatics Privacy Operations Support Expert

Scope

Operational privacy support for legal entities/sites and business units/global functions

Purpose

Privacy Operations is a global supporting organization as part of Group Functions Informatics to support operational aspects of data privacy. Main activity areas of Privacy Operations will be monitoring and executing processes related to CCPA compliance and privacy, coordination between all stakeholders; liaise with divisional and local operational groups, IT operations and / or eDiscovery for data retrieval tasks as well as keeping track of approval workflows.

Role in context

The Privacy Operations will work closely together with the Global Privacy Office, covering operational and coordination aspects of processes related to data privacy and CCPA. Privacy Operations will be the interface between DPO and Information Security, Quality and Risk.

General Responsibilities

The Privacy Operations Expert understands the overall objectives of CCPA and data privacy in general and specifically at Roche. He/she is able to interpret the Data Privacy Policy and underlying standards. He/she will work closely with data privacy coordinators, local DPOs and operational groups throughout the divisions for all privacy related questions. This role ensures the timely execution of process workflows on a global level and supports them on a local or divisional level in order to meet all CCPA compliance targets.

Specific Responsibilities

Operational responsibilities

Support all processes related to CCPA and Data Privacy regulations compliance:

· Support the Global DPO / Local DPO in the context of a Data Subject Access

Requests and Data Breach, covering documentation and communication tasks

Manages global data subject access requests

· Identifies data scope (privacy register / user story analysis)

· Identifies, contacts and supports business data owners and IT solution owners

· Coordinates data handling processes

· Liaises with original request recipients and internal supporting functions

· Close daily collaboration with the DPO Office

· Documents and keeps track of requests Client. to CCPA requirements

Supports local data subject access requests

· Supports local / divisional data subject requests

· Supports the local privacy organization (DPC, DPO) with process expertise

· Monitors correct execution of processes

· Monitors correct and complete documentation

Training responsibilities

Contributes to training creation and maintenance by providing subject matter expertise and draft content related to privacy operations

Required profile

· Has a degree in Information Technology, ideally combined with data privacy/legal specialization

· Has an in depth understanding of Data Privacy and CCPA

· Has a strong sense of ownership for the Data Privacy Policy, standards and instructions issued by the global Data Protection Office

· Self-disciplined and capable of identifying and completing critical tasks independently and with a sense of urgency.

· Strong communication, problem solving and analytical skills required

· Is able to execute accurately and pragmatically

· Is fluent in English, other languages are a plus

Source: Job Diva – Job Listing

Global, Value and Access Consultant (19-01036) – NJ – Woodcliff Lake

The Global Contractor– Oncology provides strategic market access/HTA strategies and HEOR input to the Oncology Business Unit Leadership Team to ensure patient and payer-centric product development. The Global Contractor, GV&A will drive the development and alignment of value proposition strategies with clinical, regulatory, medical affairs, and commercial/field team. The Global Contractor – Oncology will report to the Senior Global Director – Oncology.

The Global Contractor, GV&A will be responsible for Value and Access Strategies for key Client oncology products,) as well as new products and indications. In collaboration with Global Market Access Contractor will support reimbursement activities for key oncology products in all markets.

Developing and executing comprehensive global HE and HTA strategies and implementation plans in collaboration with the Global Market Access and the Regional Market Access partners.

Demonstrate strong technical abilities in SLR, ITC, NMA, economic modelling (BIM and CEA), real world evidence, patient-reported outcomes, and GVD execution, and vendor management.

This is a dynamic, experienced individual, with very strong presentation and technical skills, with 7-10 years’ experience in the field of health outcomes and health economics within a pharmaceutical company or consulting, who enjoys working as a team and is looking to work in a rewarding fast-growing therapy area.

Responsibilities Percent of Time
1. Strategic Input into Oncology Leadership Team / Product Development Plans
• Drive alignment across complex matrix of clinical, medical affairs, commercial and value & access functions as well as local country affiliates to deliver an integrated global payer perspective.
• Serve as the subject matter expert on HEOR, pricing and reimbursement at the leadership team and provide key input to the clinical development plan and global regulatory plans.
• Collaborate internally with clinical development, biostatistics, and medical affairs to ensure that strategically appropriate payer- and patient- relevant endpoints are include in phase 2-4 trials. Critically assess every protocol and provide recommendations on study designs, comparator selection and outcomes measures.
• Create and implement Patient Reported Outcomes strategy: recommendation for PRO selection in clinical trials, PRO SAP, FDA/EMA PRO submissions, utility analyses and publications.
• Provide HEOR and P&R input to development and launch teams.
• In collaboration with Clinical, Medical Affairs and Regulatory Affairs, develop clinical strategy early in product development that supports broad market access.
• Work with commercial areas and clinical affairs to gather feedback from key opinion leaders and understand global reimbursement pathways; Lead cross functional initiatives and collaborate with Medical Affairs, Clinical, R&D, local Market Access and Affiliates to ensure solid understanding of global payer markets and emerging stakeholders in the reimbursement area and translate reimbursement requirements into product specifications and assess potential reward and risk.
• Provide estimates of pricing & reimbursement expectations and necessary future HEOR investments for business development reviews and existing products.
• Monitor healthcare legislative changes and proactively modify product reimbursement and market access plans to manage; communicate impact and recommendations to the leadership team. 20%
1. Strategic Input into Oncology Leadership Team / Product Development Plans
• Drive alignment across complex matrix of clinical, medical affairs, commercial and value & access functions as well as local country affiliates to deliver an integrated global payer perspective.
• Serve as the subject matter expert on HEOR, pricing and reimbursement at the leadership team and provide key input to the clinical development plan and global regulatory plans.
• Collaborate internally with clinical development, biostatistics, and medical affairs to ensure that strategically appropriate payer- and patient- relevant endpoints are include in phase 2-4 trials. Critically assess every protocol and provide recommendations on study designs, comparator selection and outcomes measures.
• Create and implement Patient Reported Outcomes strategy: recommendation for PRO selection in clinical trials, PRO SAP, FDA/EMA PRO submissions, utility analyses and publications.
• Provide HEOR and P&R input to development and launch teams.
• In collaboration with Clinical, Medical Affairs and Regulatory Affairs, develop clinical strategy early in product development that supports broad market access.
• Work with commercial areas and clinical affairs to gather feedback from key opinion leaders and understand global reimbursement pathways; Lead cross functional initiatives and collaborate with Medical Affairs, Clinical, R&D, local Market Access and Affiliates to ensure solid understanding of global payer markets and emerging stakeholders in the reimbursement area and translate reimbursement requirements into product specifications and assess potential reward and risk.
• Provide estimates of pricing & reimbursement expectations and necessary future HEOR investments for business development reviews and existing products.
• Monitor healthcare legislative changes and proactively modify product reimbursement and market access plans to manage; communicate impact and recommendations to the leadership team. 20%
2. Value Evidence Generation
• Drive high quality evidence generation methodologies and execution of timely deliverables for the Oncology BU, in collaboration with Medical Affairs and Product Creation Unit.
• Develop comprehensive outcomes research plans to identify and address evidentiary gaps for pricing and reimbursement submissions, patient-reported outcomes submissions, and health policy submissions.
• Provide advice and guidance for best practice in evidence generation strategies and methodologies, including enabling external scientific advice, ensuring appropriate protocol review committee’s advice sought and incorporated.
• Conduct systematic literature reviews, comparative effectiveness assessments, and indirect treatment comparisons to identify areas of value differentiation, opportunities for strategic evidence generation.
• Develop economic models and reports both for cost-effectiveness and budget impact analyses, as well as strong understanding of economic modelling methods, extrapolations and sensitivity analyses
• Conduct ITC and NMA and comparative effectiveness analyses
• Conduct Real Work Evidence research including retrospective and prospective studies.
• Develop and execute an effective and resource-efficient publication plan in collaboration with the clinical, medical affairs, and publication teams 40%
3. Global Value Dossier
• Develop accurate, succinct, and life-cycle appropriate global value dossiers to prepare country market access leads for pricing & reimbursement submissions.
• Validate payer messaging and utility of deliverables through affiliate feedback and external research.
• Develop and effectively collaborate on clinically appropriate cost-effectiveness and budget impact models with Market Access team and regional stakeholders.
• Confirm structural accuracy and support the provision of model inputs.
• Develop appropriate value story training materials to expedite communication of key strategic data and messages to support optimal market access. 30%
4. Global Market Access
• In collaboration with Global Market Access – Oncology, support market access country affiliates in securing successful reimbursement of Client oncology products by innovative market access tactics.
• Review business development opportunities from a market access perspective ensuring the reimbursability and pricing potentials of the assessed opportunity.
• Inform ideas and options through effective engagement with external experts, HTA agencies, methodology and policy forums, and by leveraging knowledge of the external policy and decision maker environment, enabling more efficient evidence development and /or optimizing demonstration of differentiation for both discovery assets and later medicines in development.
• KOL engagement and management 10%

• Degree in medicine, pharmacy, life sciences, economics or statistics
• A postgraduate degree such as Masters, MPH, or PhD in the area of Health Outcomes/Health Economics
• Minimum of 7 years’ experience in health outcomes.
• Competence in carrying out a variety of HEOR studies using a range of standard techniques including PRO validation, SLRs, ITC, NMA, Survival analysis
• Hands on experience of economic modeling projects, and HTA relevant statistical methodologies
• Solid background in the design and conduct of Health Technology Assessments (HTA) in and proven record of achieving local market access and favorable pricing in HTA driven markets such as UK, Sweden, Canada, or Australia
• Strong Excel modelling skills
• Effective analytical/problem solving skills, including generation of original and innovative ideas and solutions
• Experience of the preparation and delivery of HE communications: abstracts, posters and presentations for scientific conferences; manuscripts for peer-reviewed journals
• Action-oriented, customer-focused, with effective prioritization, goal-setting and time management skills
• Experience in the design of claims analysis and observational studies is desirable
• Effective interpersonal skills; projection of professional image and credibility; teamwork oriented and inclusive
• Ability to work cross-functionally within teams
Source: Job Diva – Job Listing

Technical Writer (19-01033) – AZ – Tucson

Duties:
Serves as a primary interface between project teams and Technical Documentation Department, acts as liaison to project leader, conducts formal meetings, track project status and resolves any communication barriers.
Designs, develops, tests, and maintains documentation associated with the design, manufacture, test, release, installation, and distribution within established -schedule and budget targets.
Creates, writes and edits high quality text and graphics, using easy-to-understand grammar, excellent writing structure and good punctuation.
Uses desktop publishing tools skillfully to produce efficient and accurate documentation.
Assists in ancillary services and interdepartmental activities or applications required for publication, preparation, storage and delivery of documentation.
Assists in the maintenance of translated documents, updates and storage as required.
Maintains departmental tools, processes and libraries.
Helps maintain all desktop publishing tools that are required to skillfully produce efficient and accurate labeling documentation.

Qualification:
Bachelor's Degree in a scientific discipline or business administration or other related technical field
5 years years of direct documentation experience in medical device, software, pharmaceutical, or biotechnology industry.
Authoritative knowledge of current US and International regulations as it pertains to documentation (e.g., FDA, ISO, IVDD and 21 CFR 11), and control of electronic records.

Skills:
Specific job knowledge of Technical Publications activities and requirements, change control and configuration management.
Excellent skills in communication, negotiation, motivation and persuasion required.
Must have excellent technical writing skills and knowledge of desktop publishing and online help, including, but not limited to, Word, FrameMaker, RoboHelp, and WebWorks. Illustrating, graphics, and screen capture experience (PhotoShop, Corel Draw, Paint Shop Pro) a plus.
Knowledge of word processor, spreadsheets, project management, and electronic document management software

Source: Job Diva – Job Listing

Senior Trial Operations Manager (19-01032) – NJ – East Hanover

Job Purpose
Under the direction of TOM Development Unit Head, the Senior TOM will be accountable for the oversight and coordination of the global Monitoring operational aspects of assigned clinical trials with particular focus on pivotal trials, from start-up to close-out, in collaboration with GCT/ICT/CTTs, regions and CPOs, in compliance with *** processes, GCP, ICH and regulatory requirements.
Scope of activities range from trial start-up to close-out including strategic and operational planning, feasibility assessment, trial allocation, start-up activities coordination, patient recruitment, clinical data collection and delivery of timely, high quality submission data, sites close-out, audit organization and inspection preparation activities. Contribute to the implementation of the Trial Monitoring strategy in the assigned clinical trials.
Major Accountabilities
Trial Monitoring strategy
Partners and agrees with GPT/GCT/ICT/CTT on trials execution plans and timeline commitments in alignment with Trial Monitoring strategy and on behalf of the Trial Monitoring organization to achieve global and regional/local business. Communicates planned milestones to Trial Monitoring stakeholders and update GCT/ICT/CTTs on operational activities at the Region/CPO level, during the course of the trials to meet GPT Objectives
Participates in the development of innovative solutions in clinical trial planning and execution, including country, site and patient engagement to ensure the delivery of assigned studies on time
Provides ongoing information and regular updates to the Trial Monitoring organization, including remediation actions
Is a core member of the assigned TOM Development Unit Team
Actively participates to the development of reporting methodologies, and implements performance reporting for trial monitoring, ensures accurate and complete of operational data within corporate systems (i.e ClinAdmin, DARWIN)
May be the delegate of TOM Development Unit Head for specific teams or activities
Allocation, initiation and conduct of trials
Is responsible to have trials execution according to enrolment commitment and timelines delivered per established GDD key performance indicators
Develops planning for prospective management of clinical trials including operational risks for each phase of the trial (Feasibility/allocation, Start-up, Data collection and cleaning) using available internal and external resources (patients’ incidence, competitive landscape regional strategies, data, statistical plan)
Drives conduct of medical and operational feasibilities and communicates aggregated feedback to clinical teams; supports protocol development based on the feasibility feedback collected, ensures feedback given during feasibility process is answered and provided to regions and CPOs. Evaluates potential challenges/risks within the protocol and operational aspects of the study; assessing impacts, developing risk management plans and communicating/escalating, as appropriate
Leads trial allocation process to ensure adequate patient accessibility and alignment with regional and country strategies, including re-allocation or corrective action when needed

At least 8 years’ experience in clinical research, in planning/executing and/or monitoring clinical trials
Solid understanding of all aspects of clinical drug development with particular emphasis on clinical trial design, trial execution, project management and operations
Demonstrated ability to collaborate across partner functions in a matrix environment, without direct reports, but can coordinate the activities of others
Project/trial management and/or CRA or CRA management, Clinical Study Managers experience preferred
Proven ability to manage operational challenges at global, regional or country level for large complex trials with minimal supervision
Excellent project management capabilities with demonstrated ability to problem solve and mediate complex issues
Thorough knowledge of the international aspects of drug development process, the international standards (GCP/ICH), health authorities (FDA/EMEA), local/National health authorities regulations, *** standards, and clinical development process
Understand and apply medical and business knowledge to clinical trial execution
Excellent negotiation and conflict resolution skills
Demonstrated ability to influence without direct authority
Strong interpersonal skills
Excellent organizational, interpersonal skills with extensive networking expected
Communicates effectively with senior leaders in a local/regional/global matrixed environment
Source: Job Diva – Job Listing

Direct Hire – Sr Clinical Database Analyst (19-01029) – NJ – Woodcliff Lake

Key Responsibilities:
• Develop and program EDC Databases accordingly to the Protocol with quality and efficiency to support the Oncology clinical data management to conduct clinical trials.
• Lead the study database design, edit checks programming, study deployment and study maintenance of eDC trials.
• Provide technical expertise to the clinical team members in the areas of clinical database design and programming.
• Develop EDC studies using Central Designer 2.x which includes CRF screen design and edit checks programming for InForm 6.x studies.
• Perform review, approval, and execution of QC test scripts for any related clinical studies activities before UAT and Production releases.
• Create Ad-hoc listings to support Data Management and other clinical areas for data cleaning, data reviewing, and trial monitoring functions.
• Develop External data specification for vendor related data eg., Labs, PK, Bio Marker and etc.
• Perform and support user management, trial deployment, post-production changes, trial decommissioning/ archival/submission and vendor related support.

Qualifications:
Education Guidelines: BS/MS in equivalent degree in Biotechnology, Computer Science, Engineering, Mathematics, Biological Science or related field 3 – 5 years of experience, or Master’s degree with 2 – 3 years of experience in Data Operations methods and processes in industry setting.
Source: Job Diva – Job Listing

Direct Hire – Director, Database Operations (19-01028) – NJ – Woodcliff Lake

Duties
The Director of Data Operations – Database Development in Integrated Oncology Data Services (IODS), Oncology Business Group (OBG), will oversee the development, programming and management of EDC clinical database and related systems such as IxRS and other vendors systems.

This includes, but is not limited to: Database design and build, edit check programming, data retrieval and integration, standard EDC libraries development and maintenance. Oversee the integration of related systems to study databases; external data transfers; provide study database related technical and end user support to other areas of Data Operations, Data Management, and Clinical team; liaise with external vendors for all technical issues related to clinical databases within Oncology Business Group.

Key Responsibilities:
• Assist the Executive Director of Data Operations in establishing the strategy and standards to achieve departmental /company goals.
• Oversee the Database Development process from Study start-up to Study Decommissioning, ensuring quality, efficiency in order to meet all department and company required timelines
• Provide technical guidance to the Database Development and IxRS system in terms of programming, analysis, solution techniques, and approaches.
• Develop/maintain Oncology standard EDC library which includes database design, edit checks programming, standard functions, and reports.
• Proactively identify and track Oncology Data Management need in terms of database development, and propose/implement solutions.
• Coordinate the activities related to trouble shooting, end user support, and provide resolutions in a timely manner.

Qualifications:
Master degree in Computer Science or related fields with at least 10 years of hands-on experience in clinical database development and support using EDC systems and IxRS systems, including 3-5 years of project management; 3-5 years experience in people management experience;

Expertise knowledge of EDC systems (InForm and/or Rave), database structure, annotated eCRFs, edit checks, external data handling, medical coding, Clinical Data Management process, FDA regulations, system validation & QC methodologies.

Excellent oral and written communication skills; strong leadership skills, good organizational skills to effectively manage and guide multiple resources involved in various projects
Source: Job Diva – Job Listing

Technical Writer I (19-01027) – AZ – Tucson

Duties:
Serves as a primary interface between project teams and Technical Documentation Department, acts as liaison to project leader, conducts formal meetings, track project status and resolves any communication barriers.
Designs, develops, tests, and maintains documentation associated with the design, manufacture, test, release, installation, and distribution within established -schedule and budget targets.
Creates, writes and edits high quality text and graphics, using easy-to-understand grammar, excellent writing structure and good punctuation.
Uses desktop publishing tools skillfully to produce efficient and accurate documentation.
Assists in ancillary services and interdepartmental activities or applications required for publication, preparation, storage and delivery of documentation.
Assists in the maintenance of translated documents, updates and storage as required.
Maintains departmental tools, processes and libraries.
Helps maintain all desktop publishing tools that are required to skillfully produce efficient and accurate labeling documentation.

Qualification:
Bachelor's Degree in a scientific discipline or business administration or other related technical field
5 years years of direct documentation experience in medical device, software, pharmaceutical, or biotechnology industry.
Authoritative knowledge of current US and International regulations as it pertains to documentation (e.g., FDA, ISO, IVDD and 21 CFR 11), and control of electronic records.

Skills:
Specific job knowledge of Technical Publications activities and requirements, change control and configuration management.
Excellent skills in communication, negotiation, motivation and persuasion required.
Must have excellent technical writing skills and knowledge of desktop publishing and online help, including, but not limited to, Word, FrameMaker, RoboHelp, and WebWorks. Illustrating, graphics, and screen capture experience (PhotoShop, Corel Draw, Paint Shop Pro) a plus.
Knowledge of word processor, spreadsheets, project management, and electronic document management software

Source: Job Diva – Job Listing

Regulatory Affairs Specialist III (19-01026) – PA – Swiftwater

Duties:
Candidate to author/review/approve CMC technical documents in Company’s internal document system to support regulatory submissions (may include BLA, MAA, IND, supplements) to US FDA and international Health Authorities. 
Must have working knowledge of biologic/drug regulations (FDA, ICH, EU, etc) related to CMC.  Provide regulatory guidance for development projects, post-approval CMC changes/variations. Must have working knowledge of GMPs.  Must be well-organized, work with minimal management and meet aggressive timelines. Utilizes knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality.   

Experience with drug/biologics licensure
Prior regulatory experience 
Technical writing experience (CMC experience) Scientific background

Skills:
CMC/ Regulatory writing experience – 3 + years authoring CMC regulatory documents including Module 2 and Module 2.3
Scientific background, vaccines preferred Microsoft Office (word, excel, powerpoint) Documentum/ Veeva Applications Trackwise Applications ICH Guidelines GMP experience
Experience with drug/biologics licensure preferred
Prior regulatory experience 

Education: BS in Biology/Chemistry or related field
 
Source: Job Diva – Job Listing