Iqvia Jobs in Usa

Job Summary:

To provide product management, modeling and commercial analytics to support PAI’s strategic product development and life cycle management. This role will manage the functions including product forecasting, 5YSP/Budget, competitive analytics, business management and insights reporting and product launch coordination to support growth and sales operations.

• Responsible for supporting business case development, business development modeling, and modeling new product targets

• Responsible for performing commercial analytics, insight generation and competitive analysis

• Supports launch planning

• Contributes to Finance quarterly planning cycle for 5YSP/Budget

• Supports portfolio sales economics

• Provides holistic support to Finance & Leadership teams

Duties and Responsibilities:

1. Lead commercial business insights and reporting to support growth and commercial execution, to include but not limited to competitive and market share analysis, business and competitive intelligence reporting, product performance and ad-hoc.

2. Lead the product forecasting/modeling for all commercial products which supports business case development, demand planning, manufacturing readiness, and financial budgeting.

3. Contributes to finance quarterly planning cycle, including owning commercial re-forecasting model and supporting portfolio sales economics.

4. Manages various in support of overall analysis of PAI Pharma’s revenue, including holistic support of the finance and leadership teams in understanding portfolio changes, even those driven outside the commercial team (BD, R&D, etc.)

5. Delivers adhoc analysis in conjunction with finance team in support of commercial, executive, & finance leadership

6. Be the product expert.

7. Support the development of marketing materials to support existing and new product launches, including sell sheets, product catalog, PR, advertising, podium, white papers, etc.

8. Support and coordinate the execution of new product launch plans.

9. Support commercial and market assessment to drive execution of new product launches and achieve product targets.

10. Support the management and reporting of pipeline postmortem and launch success tracking.

11. Nurtures a team environment of accountability, continuous improvement and best-in-class performance.

12. Assist and manage projects to meet organizational and customer requirements.

ACCOUNTABILITY

For the accuracy and timeliness of all work performed.

SUPERVISORY RESPONSIBILITIES

Manage the product management for assigned products and business analytics process to drive commercial execution.

Education and Experience:

Proven working experience in marketing and product management, preferably in the generic pharmaceutical industry

• Working knowledge of data management and business analytics to derive business and competitive insights

• Ability to think strategically and to lead

• Strong client-facing and communication skills

• Advanced troubleshooting and multi-tasking skills

• Skilled in Excel, PowerPoint and Word

• Solid proficiency and knowledge of commonly used pharmaceutical industry databases like IQVIA, ProspectoRx, First Databank, etc.

• Knowledge of FDA websites

• BS degree in Business Administration or related field

• Minimum 5-7 years of industry related experience

The pay range for this position at commencement of employment is expected to be between $100,000-$140,000; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided to employees who receive an offer of employment.

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Physical Requirements/ Working Conditions:

EQUIPMENT AND MACHINES

Personal computer and standard office equipment.

WORKING CONDITIONS

Office environment. Occasional business travel may be required.

To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. PAI is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. PAI uses E-Verify.

PAI Pharma is a nicotine-free campus, meaning the use of nicotine products—including cigarettes, vaping, chewing tobacco, and any other nicotine-containing substances—is strictly prohibited on company property. All employees should be able to complete their full shift without the need to use nicotine. By joining PAI Pharma, you agree to adhere to our nicotine-free workplace policy, which supports a healthier environment for all employees.

EEO Employer / Veteran / Disabled

Site Research Assistant – Merrillville, IN

Work Setup: On-site

Scheduled Hours: 40 hours per week

About IQVIA

IQVIA is a global leader in advanced analytics, technology solutions, and clinical research services, dedicated to driving healthcare forward. We partner with the world’s leading pharmaceutical, biotechnology, and medical device companies to improve patient outcomes and accelerate innovation. Our team combines deep scientific expertise with cutting-edge technology to deliver high-quality data and insights that shape the future of clinical trials.

Job Summary

The Research Assistant plays a critical role in supporting clinical trial activities in accordance with GCP, IRB, and all applicable regulatory requirements. This position requires strong attention to detail, the ability to prioritize in a fast‑paced environment, and excellent communication skills. Experience in cardiovascular studies and hands‑on familiarity with EDC entry, query resolution, prescreening referrals, reviewing charts from site databases, and related clinical research tasks are highly valued.

Key Responsibilities

• Perform EDC data entry and query resolution in a timely and accurate manner.
• Review patient charts and records from the site database to support protocol‑required tasks.
• Build and maintain strong working relationships with investigators, clinical staff, and study teams.
• Assist in screening, prescreening referrals, recruiting, and enrolling research participants.
• Manage scheduling of participants, visit scheduling, reminders, and protocol‑related procedures.
• Collect participant history and coordinate laboratory requirements and follow‑up care.
• Support the informed consent process, ensuring adherence to IRB‑approved protocols.
• Promote participant safety by following protocol guidelines and reporting requirements.
• Ensure compliance with Sponsor and company SOPs, policies, and regulatory guidelines.
• Maintain study supplies and support upkeep of the regulatory binder.
• Record (but not obtain) vital signs as required by study protocol.

Qualifications

• Minimum of an associate’s degree or equivalent education and experience.
• At least 1 year of experience in a clinical research setting (preferred).
• Working knowledge of clinical trials, GCP principles, and study‑specific procedures.
• Familiarity with cardiovascular studies (preferred).
• Demonstrated experience with:
• Reviewing charts from site databases
• Prescreening referrals
• EDC entry and query resolution
• Visit scheduling and reminders
• Maintaining study supplies
• Upkeep of regulatory binders
• Recording (not obtaining) vital signs
• Ability to perform required clinical procedures and understand medical terminology.
• High attention to detail and strong organizational skills.
• Ability to collaborate effectively with coworkers, physicians, patients, and study stakeholders.
• Certifications and licenses as required by company, state, country, or regulatory bodies.

Note: This position is not eligible for sponsorship.

Company Overview:

Luye Pharma is fast-growing pharmaceutical company committed to advancing innovative therapies for Central Nervous System (CNS) disorders, with a primary focus on schizophrenia. Our pipeline includes promising new treatments such as Erzofri and Rykindo, which are set to launch in the U.S. market.

Position Summary:

In this role, you will collaborate closely with the US Head of Commercial Operations to design, implement, and manage data analytics and performance reporting systems. Your main responsibility will be to provide actionable insights that support decision-making and drive improvements in commercial outcomes. As the Manager of Commercial Analytics, you will serve as a key analytics partner for commercial leaders across sales, marketing, and operations in the US. You will offer valuable insights and recommendations to fuel growth, optimize field performance, and analyze market and patient trends. Additional key responsibilities include developing reporting processes and assisting with the coordination of Monthly Business Reviews, focusing on KPIs, forecasting variances, and updates to the Latest Estimate.

Report to: Head of Commercial Operation

Key Responsibilites:

• Develop and maintain performance dashboards and reports, integrating internal KPIs and external datasets to track business metrics, monitor progress toward sales goals, and evaluate operational performance.
• Conduct in-depth analysis of market trends and product performance to identify growth opportunities and risks.
• Evaluate overall business performance, including volume, market share, new patient starts, and KPIs, comparing actuals against forecasts and targets.
• Partner with Sales and Commercial Leadership to optimize territory alignments, call planning, and customer targeting, using analytical insights to improve sales coverage and operational efficiency.
• Assess performance and activity trends at sub-national levels to uncover opportunities, inefficiencies, and areas for improvement within the sales force.
• Prepare monthly business reviews, utilizing a combination of third-party market data (e.g., prescriber, chargebacks, 867, 852 data) and internal performance metrics to guide executive decision-making.
• Build and maintain performance dashboards and reports by integrating internal KPIs and third-party datasets to monitor business metrics, track progress against sales goals, and evaluate operational performance.
• Assist in designing incentive compensation structures and performance metrics, including goal setting and attainment analysis.
• Analyze market trends, physician and account-level data, and promotional effectiveness to support segmentation, targeting, and brand strategy.
• Provide support to field teams by addressing data and reporting requests, resolving inquiries, and delivering actionable insights for daily execution.
• Collaborate with cross-functional teams to develop demand forecast models.
• Conduct data analysis, reporting, and generate actionable insights to support commercial brand strategy and execution.
• Other duties as assigned.

Qualifications:

• Bachelor’s degree
• 3-5 years of experience in relevant analytics roles within the pharmaceutical or life sciences industry.
• Strong understanding of the pharmaceutical industry and familiarity with third-party data sources (e.g., Symphony Health, IQVIA, etc.).
• Strong proficiency in Excel
• Exceptional analytical capabilities, including the ability to manipulate large data sets and apply advanced analytical methodologies.
• Experience with BI tools (Tableau, Power BI, Qlik etc.) preferred.

To all recruitment agencies: Luye does not accept unsolicited third party resumes, and all resumes must be submitted to HR Function.

The starting compensation range(s) for this role are listed for a full-time employee (FTE) basis. Additional incentive may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Luye Pharma is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

Notice: MCRA’s Talent Solutions division works to unite top talent with opportunities on our clients’ teams. This posting is not for a position directly at MCRA, but rather for a position with a MCRA client that our team is helping to recruit and fill.

MCRA's client, a commercial-stage medical device company specializing in designing, developing, and marketing orthopedic fracture repair and stabilization products, is in search of a Director of Quality and Regulatory Affairs to provide support across Regulatory, Quality Assurance, Operations, and Research & Development (R&D).

Primary Roles:

• Is a key member of the senior leadership, and is responsible for the successful operation of the company's quality and regulatory systems. Essential functions include the development, implementation, maintenance, and improvement of company-wide quality and regulatory systems, integrating continuous improvement activities.
• Serves as our clients Management Representative under ISO and FDA requirements, and takes the lead role in ensuring that the quality management system is efficient, effectively implemented and ensures compliance with the requirements of applicable regulatory agencies. Responsible for the generation and maintenance of our client's Quality systems, with direct oversight for the processes for Complaints Management, CAPA, Risk Management, Post-Market Surveillance, and Regulatory Reporting.
• Is responsible for leading the resolution of quality and compliance issues within the business and provide routine quality feedback and leadership to cross-functional groups
• Serves as the official correspondent to Competent Authorities (e.g. FDA, EU countries, etc) as well as Notified Body. Responsible for maintaining compliance registrations and device listings.
• Ensuring compliance with FDA and other applicable international regulations and requirements for the design, development, distribution, and maintenance of medical devices and provide general regulatory support to the organization

Responsibilities:

Quality Systems

• Provide operational leadership in planning and management of quality system activities to maintain appropriate QMS certification
• Responsible for leading and interfacing with any Notified Bodies or Competent Authorities during inquiries or facility inspections by such organizations
• Acts as lead in all product complaint and recall campaigns.
• Responsible for interfacing with and following up with any Customers regarding complaints
• Responsible for Supplier Quality assurance program
• Responsible for Measurement, analysis and improvement programs, including quality trending, CAPA system, and the Internal Quality Audit program for our client.
• Leads the Management Review process

Quality Engineering

• Ensures all inspection and quality plans are statistically sound and can ensure quality levels that exceed requirements
• Ensures all device history records are complete and reviewed prior to release of product
• Assist suppliers by providing information to enable process improvements
• Ensure all manufactured products are conforming to FDA Quality System, ISO 13485, MDD, and MDR
• Supports the engineering staff with PPQA activities, validations, and statistical analysis of new products and processes
• Leads Risk Management and Post-Market Surveillance activities

Regulatory Affairs

• Develop and implement global regulatory and compliance strategies to:
• Ensure all products designed, manufactured and/or shipped meet all regulatory, corporate and customer requirements for quality, safety and efficacy;
• Ensure proper and timely preparation and maintenance of national and international new product submissions, registration/licensing renewals, product listings, post market surveillance reports, import and export documents, safety testing, and other national and international requirement
• Optimize and focus on quality during the design and change control processes for both new and existing products;
• Ensure all advertising and promotion materials conform to applicable FDA, EU, and, where applicable, other country regulations.
• Responsible for the CE Mark approval process for all products, and Technical File generation and maintenance
• Responsible for writing Letters to File as required
• Participates in the development and writing of 510(k) submissions with the management team utilizing external resources as required
• Responsible for external agency reporting

Education:

• Bachelor’s Degree in Engineering or Natural Science preferred, coupled with approximately 10 years of combined experience in QA / RA in the medical devices industry; experience regarding medical device design, development and manufacturing regulations, especially 21 CFR Part 820 Quality System Regulation, the MDD and MDR Directives, as well as ISO 13485 requirements. 5 years of experience managing supervisory personnel and contributing toward the development of department strategies.

Experience/ Skills:

• Ability to build efficient quality assurance systems; including electronic document and record control, CAPA, NCR, complaint, training, metrics
• Demonstrated ability to write, review, execute and critique validation protocols, investigation plans, root cause analyses, NCRs, CAPAs, complaints, trend report
• Has experience with applying ISO 14971 principles to medical devices throughout all stages of the product's lifecycle.
• Demonstrated leadership skills and team building skills, inspires others toward continuous quality improvement
• Able to solve complex quality, technical, managerial or budgeting problems
• Readily adapts to changing priorities, effectively manages own time and direct reports to ensure tasks, projects are completed on time to meet growth objectives. Adjusts easily and readily to a fast-paced work environment
• Working knowledge of data acquisition, analysis and statistical software
• Demonstrated ability to manage multiple projects and technical personnel simultaneously
• Successful oral and written communication skills, business acumen and assertive decision-making ability
• Excellent computer skills, including MS Office proficiency

NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as to meet the ongoing needs of the organization.

MCRA, LLC is an equal opportunity/Affirmative Action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

Join the IQVIA team, where diversity and inclusion thrive in a workplace committed to improving patients' lives.

We recognize that our employees are crucial to our mission's success and have been acknowledged as a fantastic workplace.

At IQVIA, we provide benefits and programs to empower you to develop and advance in your career.