Total 6 job vacancies by 5PY US Quintiles, Inc.

*This Position is Remote in North America*

The IQVIA Cell and Gene Therapy Center of Excellence, a hub of CAGT clinical innovation, is growing! We are looking for exceptional Board-Certified physicians to join our team as a Medical Strategy Lead to help us expand our CAGT portfolio and advance this dynamic and rapidly expanding area of clinical development.

The CAGT Medical Strategy Lead is a subject matter expert with experience in clinical research and clinical trials who will be a champion for CAGT across IQVIA.

The key remit of the role is drive growth of the IQVIA CAGT portfolio through scientific and clinical expertise. The Medical Strategy Lead will be charged with using his/her clinical, scientific, and operational knowledge to harness the vast IQVIA data and clinical trial resources to develop innovative, data-driven, and patient-centered solutions for CAGT trials.

The Medical Strategy Lead will provide senior clinical and scientific expertise to all IQVIA divisions as requested and will collaborate closely with indication-specific teams to develop integrated strategies for CAGT clinical trials and studies. The Medical Strategy Lead will also be responsible for early engagement business development activities, providing scientific knowledge and expertise to guide sponsors in CAGT development.

As a subject matter expert, the Medical Strategy Lead will drive thought leadership activities including presentations, publications, and interactions with the medical scientific community.

RESPONSIBILITIES:

• Accountable and responsible for creating innovative, evidence-based, and patient-centered delivery strategies and solutions for CAGT trials or studies, addressing the specific needs and challenges of each customer.

• In partnership with Indication-Specific Medical Strategy, Operations, Sales, and other functions, responsible for award of strategic and tactical new business to achieve annual Gross New Business targets. Responsible for the inclusion of CAGT elements into proposals.

• Provide scientific, clinical, and operational advice to internal stakeholders developing proposals: this may include, but is not limited to, providing the strategy to protocol design/clinical development plan, mining data to address important clinical questions relevant to the study, reviewing the protocol for scientific/regulatory soundness and feasibility, identification of target site and principal investigator profiles, anticipated patient recruitment, standard of care and competitive landscape.

• Support preparation of customer and bid defense meetings, e.g. training and preparation of the assigned project team; provide specific content; ensure presentation focus and content effectively conveys CAGT strategy. Attends and presents at customer meeting, or bid defense or partnership meetings, as required.

• Participates in strategic business development activities including presentations to prospective clients and professional meetings.

• Maintains awareness of industry pipeline and scientific and business landscape; supports due diligence research of the CAGT landscape

• Leads CAGT thought leadership at IQVIA which may include publications, presentations, and taking a leadership role in scientific activities

REQUIREMENTS:

Scientific and Research Qualifications and Experience

• A physician with experience in Cell and Gene Therapy. A degree from an accredited and internationally recognized school is required

• 5+ years clinical research relevant experience, including hands on operational delivery and/or drug development experience

• Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in CAGT

• Excellent skills in providing consultation and advice on multiple assignments are required, as well as initiative and flexibility.

• In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements; e.g. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines

• Demonstrated ability to understand customer needs, have difficult conversations with internal/external stakeholders and customers, negotiate solutions and understand impacts on the overall offering

• Strong clinical research skills and commitment to evidence-based and patient-centered clinical development

Professional Skills

• Excellent communication, presentation and interpersonal skills, including good command of English language (both written and spoken)

• Strong leadership skills, ability to work with minimal supervision, and lead a virtual team in a matrix organization

• Innovative and strategic thinker

• Strong business acumen including confidence with financial considerations, excellent negotiation and influencing skills, and comfort working in both sales and operational environments

• Flexible and able to work in situations where specifications may or may not be well defined and willing to support work in other therapeutic areas when required

• Confident and capable in the use of technology, applications and other media e.g. databases and internet to research assess new opportunities, maintain currency of therapeutic and operational knowledge and competitive landscape.

• Proven ability to make decisions with limited information, bringing clarity to disparate information to inform actions and drive results

Interpersonal Skills

• Ability to establish and maintain effective working relationships with coworkers, managers and clients. Maintains a positive outlook at work; handles criticism well and learns from it

• Ability to establish and maintain effective working relationships with a wide network of individuals e.g. coworkers, managers and customers

• Effective mentoring and training skills, fostering learning and knowledge sharing with colleagues

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

Your opportunity

IQVIA, a leading Human Data Science company, is seeking a dynamic and experienced Senior Director of Compliance to join our Ethics and Compliance Office (ECO). In this critical leadership role, you will shape and maintain an effective healthcare compliance program on a global scale. Your responsibilities will span a wide range of duties, ensuring adherence to ethical standards and regulatory requirements.

You will interact regularly with various internal stakeholders, including Legal, Finance, Human Resources, Internal Audit, Global Quality Assurance, Chief Information Office, and all global and regional business units, as well as with external parties such as auditors, law firms, and regulators. 

As a leader, you will be a trusted member of the ECO Leadership Team, managing at least one employee and reporting to the Chief Compliance Officer, and driving a culture of ethics and integrity in all we do.

Your key responsibilities will include:

Strategic Leadership:

• Oversee IQVIA’s Code of Conduct and ethics and compliance policies.

• Manage the Ethics Line, including the Ethics Line mailbox, in accordance with applicable laws and best practices.

• Prepare materials for presentations to IQVIA’s senior leadership, Audit Committee, and external auditors.

• Provide expert guidance to internal stakeholders across Legal, Finance, Human Resources, and other departments.

• Conduct sensitive investigations as needed.

Collaboration and Stakeholder Management:

• Interact regularly with internal teams, including Legal, Finance, Internal Audit, and Global Quality Assurance.

• Build collaborative relationships with external parties such as auditors, law firms, and regulators.

People Leadership:

• Manage at least one employee.

• Report directly to the Chief Compliance Officer.

• Drive a culture of ethics and integrity throughout the organization.

To be successful on this role, you will have qualifications such as:

• Subject Matter Expertise:

  • Stay informed about global laws, regulations, and codes of ethics.

  • Provide guidance to leadership, management, and employees.

  • JD preferred, or Masters’ degree in legal relevant area, and at least 10 years of relevant experience.

  • Sound knowledge and understanding of the legal and regulatory environment in which the company operates; life sciences or healthcare compliance expertise.

• Ethics Line Management:

  • Experience managing an ethics reporting line, maintaining data and analytics, and preparing accurate, compelling presentations for a wide range of audiences including executive leadership, Audit Committee of Board of Directors, external auditors, and regulators in different regions and countries.

  • Ensure compliance with EU whistleblower laws and other relevant regulations.

• Risk Assessment:

  • Utilize deep subject matter knowledge to assess risks across various areas.

  • Experience managing Codes of Conduct and corporate policies.

  • Experienced investigator; able to guide investigations and enhance capabilities for various resources who do not regularly conduct investigations.

  • Excellent analytical and problem-solving skills; ability to synthesize and summarize complex issues.

  • Excellent judgment and discretion, including the ability to handle sensitive and/or confidential information.

You will differentiate yourself if you have:

• Relevant compliance or professional certification: Certified Compliance and Ethics Professional (CCEP), Certified Fraud Examiner (CFE).

• Life sciences outsourcing experience (e.g., CRO).

Location

• IQVIA currently offers remote work arrangements.

• The incumbent must be based anywhere on the East Coast of the United States.

How to Apply

If you are a seasoned compliance professional with a passion for ethics and integrity, we invite you to be part of our mission to advance healthcare through data science. Apply now by visiting our careers page and searching for Job ID R1393190.

We look forward to welcoming a dedicated leader to our team! 🌟

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

Job Overview

This position leads, directs and coordinates activities of a major set of key accounts within the sales organization in a large region to achieve financial and strategic growth goals across multiple accounts. The role further:

• Directs the activities of a matrixed sales teams within a large account(s) to achieve/exceed the assigned revenue and growth goals.

• Provides leadership to the sales management team to expand scope of existing contracts and identify new business opportunities.

• Develops relationships with key executives and decision makers within large and strategic accounts.

• Collaborates with all business units within R&DS (Research and Development Solutions), RWS, consulting, and client services in developing strategies to promote the full IQVIA offerings to anticipate and meet client needs.

• Provides direction to the sales management team in developing and executing comprehensive account plan(s) and monitors progress against plans.

• Works to develop associated sales and GNB goals to matrixed sales teams.

• Takes a proactive role in account and FSP (Functional Service Provider) strategy.

• Proactively works within global and regional account/sales management in the pursuit of multi-country and FSP and full-service opportunities.

Qualifications

• Bachelor’s degree in business management Req

• 15 years relevant industry experience (CRO/Pharmaceutical) Req Or

• Equivalent combination of education, training, and experience Req

• Proven track record at developing mid-level and high-level contacts.

• Solid understanding of commercialization and the principles of drug discovery and development.

• Excellent skills using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel

• Excellent oral and written communication skills.

• Strategic business awareness and analytical skills.

• Adaptability and flexibility to changing priorities.

• Demonstrated ability to work creatively and effectively in a fast-paced environment.

• Attention to detail and ability to work simultaneously on multiple priorities.

• Ability to maintain demanding timelines.

• Ability to influence others both internally and externally.

• Ability to work independently and as a team player.

• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.

#DB-LI1

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

Job Overview:

As a Lead Medical Writer on most types of writing projects. You will prepare assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Perform Senior Review of straightforward medical writing deliverables. Negotiate timelines and discusses/resolves customer comments. Provide written and verbal feedback to junior staff, and to customers when appropriate. Keep abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in drug development/medical and/or technical writing.

Responsibilities:

• Writes clear and concise clinical submission documents, including clinical study reports, protocols, clinical overviews, investigator brochures, and summary documents; experience with late-stage health authority responses is a plus.

• Contributes to project plan concerning timelines as well as organization and table layout for a specific document.

• Ensures that documents meet regulations, and the key messages as defined by the team are clearly and adequately represented.

• Review and edit documents for consistency, progression, structure, and grammar.

• Review statistical analysis plans and incorporate into clinical study reports or submission documents, as applicable.

• Drive the document preparation process, manage timelines, receive, and review primary statistical output, draft, and distribute document for review, compile comments and edits, lead comment resolution meetings independently.

• Participate in team and client meetings as requested. Deliverables above plus able to work independently on a range of complex clinical documents

• Interprets, summarizes, and presents statistical and medical information to ensure accuracy of content in highly complex document types independently

• Resolves complex problems independently

Education and Experience required:

• 8+ years of experience in medical writing or related field

• Required - Bachelors Degree in Life Sciences or related field

• Preferred - Masters or PhD in Life Sciences or related field

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

Director, Business Development - Patient Suite

The Director, Business Development works collaboratively with internal and external colleagues to increase sales within the Patient Suite Team.

Responsibilities include full cycle sales including target identification, securing and managing client meetings, listening and understanding client needs, addressing client concerns/objections, managing Subject Matter Experts in defining opportunities, proposing solutions, negotiating, obtaining SOWs and closing the deal.

Our Sales Professionals are expected to quickly develop credibility with customers/prospects and build trust through professionalism and knowledge of services and products.

Essential Duties and Responsibilities:

• Prospect accounts focusing on products and services.

• Identify and develop new accounts and follow up on existing leads.

• Develop and maintain productive relationships with key target accounts.

• Manage assigned accounts to generate both incremental and repeatable annual business.

• Initiate and manage RFI and RFP process and negotiate terms for all account programs and projects.

• Expand product portfolio in the Connected Devices market.

• Collaborate with Executives and SMEs to maximize account coverage.

Job Experience:

• 12+ years of related experience, including relevant industry experience (CRO/Pharmaceutical) and/or sales experience required.

• Must demonstrate a sustained (3 + years) and successful track record selling professional services to Pharmaceutical, Biotech, Medical Device, and/or Clinical Research Organizations.

• Demonstrated track record of success working with senior level management in a fast-paced growth environment is essential.

• Full sales cycle experience is required: Prospect, identify opportunities, Propose Solutions (writing proposals), Negotiate, Close

• Strong written and verbal skills.

• Ambitious, driven and self-motivated personality adaptable to a fast-paced high volume and high velocity sales organization.

• Bachelor’s degree or higher required.

• Willing to travel throughout the US, estimated up to 50%.

Highly preferred capabilities:

• Possess an understanding of the Connected Devices market.

• Background in selling eConsent, IRT, eCOA and Connected Devices.

• Selling Connected Device platform concepts, services and products.

• Experience working with Device manufacturers and Partner Vendors.

• Experience managing internal business partners and providing insights and concepts for winning strategies.

#DB-LI1

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status

Job Overview

• Secure and retain business through professional, consultative, and proactive sales of global CRO clinical trial services directed at decision-makers and decision influencers at sponsors currently working in the emerging biopharma space (clinical study phases I-III).

Essential Functions

• Actively prospect and leverage potential new business opportunities within specified customer account(s).

• Cultivate strong, long-term relationships with key decision-makers within Account and develop in-depth knowledge of the customer organization.

• Maintain general knowledge of all IQVIA services for appropriate cross-sell opportunities.

• Aggressively pursue awareness of competitive activities, positioning and pricing, which includes specific reasons for awards and non-awards.

• Identify and respond to customer needs in order to define potential opportunities.  Propose appropriate strategy/solution to customer.

• Coordinate with contracts/proposals to develop proposal.

• Work with operations and functional managers to identify sales team and prepares and leads the sales presentation. Educate team participants in customer culture, operational needs/methods and sales techniques needed to close the sale.

• Handle follow-up related to the sale and drive completion of contractual documents.

• Adapt successful strategies and tactics to meet market demands and financial targets.

• Maintain high visibility within customer organization.  Monitor customer satisfaction by communicating regularly with customer.

• Establish and execute a comprehensive sales plan for each target account.  Ensure appropriate strategy/solution is proposed to customer.   Monitor actions and results against plans.

• Analyze potential opportunities and develop sales plans for each target account. Ensure appropriate strategy/solution is proposed to customer.

• Monitor actions and results against plans.

• Record all customer sales related activities in CRM system.

• Prepare sales activity report for Sales Management as required.

• Serve as a liaison between the customer and technical and operational groups at IQVIA, Inc.

Qualifications

• Bachelor's degree in business management Req

• 10 years related experience, including 3 years of relevant industry (CRO/Pharmaceutical) and/or sales experience Req Or

• Equivalent combination of education, training and experience Req

• Proven track record at mid-level and high-level contacts.

• Strong organizational, planning, project management skills.

• A developing record of customer contacts at the outsourcing, procurement and mid - management level.

• Excellent Business/Industry awareness and a thorough understanding of industry trends and impact on the business.

• Excellent analytical skills in assessing and interpreting customer business data.

• Ability to maintain demanding timelines.

• Ability to influence others internally and externally.

• Adaptability and flexibility to changing priorities.

• Demonstrated ability to work creatively in a fast-paced environment.

• Exceptional attention to detail and ability to work simultaneously on multiple priorities.

• Ability to work independently and as a team player.

• Excellent skills using Microsoft Office Suite: MS PowerPoint, MS Word, and MS Excel

• Excellent oral and written communication skills

• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

#DB-LI1

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status