Job Vacancies at IQVIA

Job Overview

Develop the global contracting strategy and support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by the Sponsor’s requirements.

Essential Functions

• Develop Coordinate the development of investigator grants and estimates, contracting strategies and proposal text to support the proposal development process.
• Develop contract language, payment language and budget templates as required as applicable to the position utilize and maintain contracting systems, tools, processes, and training materials for selected sponsors, studies or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy.
• Ensure collaboration, including communication with sponsors, stakeholders and RSU regions and countries as applicable to the position, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.
• Provide specialist legal, operational and financial contracting support to the Study Teams, as applicable to site agreements to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
• Assist with the creation and/or review of core scientific, technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
• Contribute to the collection, interpretation, analysis and dissemination of accurate contracting intelligence to support assigned studies and the wider company, as required.
• Ensure overall contracting efficiency and adherence to project timelines and financial goals as applicable to site agreements report contracting performance metrics and out of scope contracting activities as required.
• Work with Quality Management to ensure appropriate contract management and quality standards. Mentor and coach colleagues as required including the delivery of training materials as required.
• Deliver presentations to clients as required. As applicable, eEnsure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans.
• May take a proactive role in developing long standing relationships with preferred IQVIA clients/customers.

Qualifications

• Bachelor's Degree Related field Req
• 5 year relevant sponsor or clinical research organization clinical site contracting experience, including demonstrable global and/ore regional experience acting as a contract negotiator. Equivalent combination of education, training and experience.

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JOB DESCRIPTION

The Manager, Regulatory Affairs International supports ambitious geographical expansion plans. The position will support registration of existing portfolio products into new territories and to register several of development projects into the international region. This role is key to driving both the Regulatory strategy and execution.

Key Responsibilities/Scope of the Job

• Represent International region in Global Regulatory Team and other cross-functional forums, for assigned products
• Develop International regulatory strategies and filing plans, in partnership with the Global Regulatory Lead, and country leads, for assigned products in development
• Plan and create a core dossier for International, in partnership with cross-functional teams, for assigned products
• Develop regulatory strategies in assigned countries, in partnership with local Regulatory teams
• Manage, plan and direct all aspects for the successful preparation, submission and timely approval of marketing applications and post-approval management for assigned countries
• Provide strategic guidance on regulations and changes in assigned countries
• Support interactions with Health Authorities in assigned countries

Position Qualifications

• Education/Learning Experience/Work Experience
• A University Degree in Life Sciences is required with 10 years of industry experience, of which at least 5 years of experience within Regulatory Affairs (registration, development, maintenance)
• Experience of regulatory requirements in countries outside the US and Europe
• Very good knowledge in written and oral English is required, knowledge of any other languages would be an asset
• Experience from leading projects and cross-functional teams

Personal Attributes

• A strong team player, with the ability to work effectively in a team setting and interact with people of different cultural, seniority and functional backgrounds
• Highly self-motivated and able to drive activities
• Excellent communication skills
• The suitable candidate should demonstrate the values; Care for our patients, for our colleagues and for our company, Ambition, Urgency, Ownership and Partnership
• Ensure exemplary behaviour, ethics and transparency within the Company and with regulatory agencies

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Responsibilities:

• Act as the primary point of contact for assigned sponsor(s) and Assocd studies.
• Manage the project timeline, identify/pursue change orders and coordinate with other stakeholders, as necessary. ·
• Prepare materials and KPI’s for sponsor Governance Meetings and participate as appropriate. ·
• Identify and execute process improvement initiatives when appropriate. ·
• Prepare, arrange and execute regular client meetings and ensure all necessary materials are presented with accuracy and completeness.
• Function as the engagement leader providing management throughout the length of the clinical trial by overseeing activities of the project team to ensure sponsor commitments and IQVIA's service levels are achieved.
• Coordinate with Site Solutions and Data Operations to ensure proper resource assignment and service delivery quality.
• Ensure that IQVIA financial interests are appropriately protected through diligent scope of work management efforts.
• Ensure support to the clinical trial sites is provided at IQVIA’s levels of excellence through timely resolution of issues that are raised via email and/or phone contact.
• Responsible for ensuring that payments do not exceed SOW timelines. ·
• Responsible for ensuring change orders are executed and communicated to appropriate personnel.
• Responsible for performance review input to Site Solutions and Data Operations for roles that support assigned sponsor.
• Coordinate with the Site Solutions and Data Operations team members to prepare and complete sponsor funding as needed.
• Ensure that all IQVIA processes and standards are followed and that appropriate financial controls are observed and are in line with sponsor requirements for managing and mitigating financial risk.
• Ensure work is SSAE 18 compliant.
• Responsible for monitoring, assist in resolving and escalating operational and performance metric issues.
• This role may require assistance from Sr. Lead or Mgr to support more difficult Lead activities

REQUIRED EDUCATION AND EXPERIENCE

• Bachelor’s Degree in Finance, Business Administration or equivalent experience
• Experience as a Site Solutions Assoc, Data Operations Assoc, or equivalent experience preferred
• Experience with financial business applications preferred
• General knowledge of Clinical Trial Industry preferred
• Project management or team leadership experience preferred
• Comfortable representing Clinical Trial Payments to internal / external stakeholders

Skills and Abilities

• Must be customer focused and have excellent written and oral communication skills
• High energy, self-starter with the ability to work in a team environment, as well as independently
• Able to think independently, and to analyze and solve problems creatively

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Responsibilities:

• Participate in bid defence presentations in partnership with Business Development and may lead the presentation for smaller, less complex regional studies.
• Develop integrated study management plans with the core project team.
• Accountable for the execution of clinical studies, or assigned portion of clinical studies, per contract while optimizing speed, quality and cost of delivery and ensuring consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
• Set objectives of the core project team and/or sub-team(s) according to agreed upon contract, strategy and approach, effectively communicate and assess performance.
• Collaborate with other functional groups within the company where necessary to support milestone achievement and to manage study issues and obstacles.
• Monitor progress against contract and prepare/present project and/or sub-team information proactively to stakeholders internally and externally
• Manage risk (positive and negative) and contingencies proactively and lead problem solving and resolution efforts.
• Achieve project quality by identifying quality risks and issues, responding to issues raised by project team and/or sub-team members and planning/implementing appropriate corrective and preventative action plans.
• May serve as primary or backup project contact with customer and would then own the relationship with the project’s key customer contacts, as well as communicate/collaborate with IQVIA business development representatives, as necessary.;
• Build the cross-functional project team and lead their efforts; responsible for managing cross-collaboration of the core team and for overall project delivery to support milestone achievement and to manage study issues and obstacles.;
• Ensure the financial success of the project.
• Forecast and identify opportunities to accelerate activities to bring revenue forward.
• Identify changes in scope and manage change control process as necessary.
• Identify lessons learned and implement best practices.
• May be assigned as the primary contact for vendors leading project vendor management and vendor management related activities as per project requirements.

Qualifications and Experience Required:

• Bachelor's degree in life sciences or related field
• Global project management experience within the drug development industry, with previous CRO experience is ideal.
• Minimum 4 years prior project management experience and experience in clinical operations; or equivalent combination of education, training and experience
• In-depth therapeutic knowledge in one of our Dermatology therapeutic area

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Job Overview:

• Serve as key FSP Solutions Design (SD) contact supporting strategic planning, direction, and execution of all new FSP business.
• Develop customized FSP solutions that resonate with IQVIA’s overall FSP business delivery strategy, our established FSP Models, and clients’ requests.
• Work with internal stakeholders to respond to client opportunities (RFI, RFP, BDM).
• Review client requests, identify needed information, and work closely with the cross-functional team (FSP Operational Heads, Business Development/Account Teams, Proposal Developers, and Strategic Pricing) to prepare and finalize the expected FSP deliverables according to timelines.
• Function as a FSP Subject Matter Expert and provide hands-on support and guidance to the rest of the cross-functional team in the delivery of assigned FSP opportunities.

Requirements:

• Requires 5 - 7 years of prior experience in clinical or Data Sciences operations, preferably with knowledge of working within FSP models.
• Requires practical knowledge in leading independently and managing the execution of processes, projects, and tactics within one department or multiple related departments
• Experience actively managing clinical research projects
• Experience of direct customer interaction and identification of their needs
• Flexibility and ability to manage multiple tasks to meet deadlines while delivering high quality work in a dynamic environment
• Thorough knowledge of FDA regulations and drug development
• Background in Data management/Statistics

What is in it for you?

• Interesting and innovative projects
• Collaborative and inspirational working environment / atmosphere
• Excellent career development and progression opportunities

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Job Overview

• Provides high quality, on-time input to client projects in the life sciences field. Assignments typically require analysis and problem solving within an established framework.
• Essential Functions
• Identification of relevant publications by HTA agencies in multiple countries/regions (“scouting”).
• Data entry of around 300 data points that need to be identified, selected, and processed from the HTA reports.
• Quality control of entered data.
• Writing a newsletter reporting on HTA and reimbursement policy developments.
• Participation in client project deliverables on diverse research questions and therapy areas.
• Provide insight into the HTA, and pricing & reimbursement processes and policies of countries (requires continuous development gaining knowledge of these systems and staying up to date
• Supporting the design and build of new technology solutions including; understanding business needs, determining product specifications, production timetables, pricing, and time-integrated plans for product introduction; developing marketing strategies.
• Conducting market research; to understand business needs and generating product requirements.
• Managing internal and external cross functional stakeholders to support product development.
• Leveraging business experience and acumen in identifying strategic alternatives to client questions.
• Working in a team of like-minded professionals to create reports, presentations, workshops with client employees, management teams and other stakeholders, under the guidance our “the best on the business” team leaders.
• Developing broad knowledge of related consulting methodologies and pharmaceutical market through the delivery of consulting engagements and participation in formal and informal learning opportunities.
• Working independently and as part of a team.
• Assisting development and writing of proposals with senior support.
• Contributing to learning, development and recruiting.

Qualifications, Skills and Knowledge

• Bachelor's Degree in Life Sciences
• 1-3 years of related experience in HTA / Market Access / Pricing and Reimbursement
• Qualification in Health Economics highly beneficial
• Strong verbal and written English language skills
• Additional language skills required: Portuguese, Italian or Spanish
• Ability to provide high quality work under time pressure
• Ability to identify and relay accurate and relevant information
• Clear communication
• Works willingly and effectively with others in and across the organization to accomplish team goals.
• Effective time management skills.

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JOB DESCRIPTION

You are expected to be a developing professional who works under moderate oversight and supervision and is responsible for making recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area.

• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines
• Perform feasibility, site ID, start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members
• Prepare site documents, reviewing for completeness and accuracy
• Review, track and follow up the progress, the approval and execution of documents, questionnaires, CDA/SIF, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines
• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information
• Review and provide feedback to management on site performance metrics.
• Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed
• Inform team members of completion of feasibility, site ID, regulatory and contractual documents for individual sites
• Provide local expertise to SAMs and project team during initial and on-going project timeline planning
• Perform quality control of documents provided by sites.
• May have direct contact with sponsors on specific initiatives
• Feasibility and efforts to identify sites across Sub Saharan Africa
• Support capacity building initiatives and Bid defense calls

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Bachelor’s Degree in Life Science or related field
• Minimum 3 years’ prior experience in life sciences or similar. Experience in a leadership capacity considered advantageous 
• Fluent/ native language capabilities, including English
• Makes recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area
• Good negotiating and communication skills with ability to challenge
• Makes recommendations for enhancements in systems and processes to solve problems or improve effectiveness of job area
• Ability to handle change and ambiguity
• Ability to work on multiple projects
• Knowledge of functional/regulatory requirements, including local regulations, SOPs and GCP/ICH

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PURPOSE:

Develop and prepare grant budgets to be included in proposals for assigned customers, to support the global sales team.

RESPONSIBILITIES:

• Review Requests for Investigator Grants as assigned through Customer Relationship Management (CRM) System.  Identify information for investigator grant budget development and work closely with proposal development team, Therapeutic Strategy Leads, and Medical Officers to prepare and finalize grant estimates  
• Obtain appropriate approvals from Therapeutic Strategy Lead and Medical Officer prior to submission to proposal developer
• Adhere to delivering investigator grant budget per proposal process to support timely delivery to Business Developer/Client
• Provide support and assistance to other Investigator Grant Analysts in the delivery of assigned opportunities
• Develop in depth understanding of and be compliant to all processes and policies relating to the development of investigator grants.
• Update and maintain corporate databases as required and ensure accurate information is included in tracking reports
• May participate in training / mentoring new staff
• Participates in department initiatives
• Perform all other duties as assigned

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES:

• Knowledge of CRO Industry
• Knowledge of Microsoft Excel, Word and understanding of Grant Plan Tool
• Ability to interpret protocols
• Possess strong analytical skills and excellent verbal and written communication skills
• Ability to establish and maintain effective working relationships with coworkers, managers and stakeholders