Analyst 2 - Quality Systems Document

20 hours per week

HEMA Processes Coordinator

Cincinnati; Ohio, United States or remote in the United States

Administration

Health Economics and Market Access (HEMA) Process Coordinator.

Caring for the world, one person at a time has inspired and united the people of Pharmaceutical for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people.

Pharmaceutical is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. Employees of the Pharmaceutical Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

This role is located in Cincinnati Ohio and will operate under the direct supervision of the HEMA Research Operations Associate Director-- providing full-time (40 hours per week) process administration support.

Basic responsibilities

Administer the approval process of research protocols using PUBSTRAT, including basic quality control, according to standardize procedures

Administer the approval process of scientific publication submissions using PUBSTRAT, including basic quality control, according to standardized procedures

Maintain entries into research process trackers and summarization of information for reporting to senior leadership

Assist in development and updating/maintenance of PUBSTRAT administrators process guidelines

Serve as main point of contact with the vendor of the PUBSTRAT platform

Document Preparation: memorandums, correspondence, and/or presentations as needed.

File management (e.g., Microsoft 365 Teams, SharePoint, Word, Adobe)

Assist in the critical review and proofread of standardize process documents

Assemble relevant data, generate reports, compile statistics or information as directed (as needed)

Conduct debarment/exclusion checks

Assist in development and maintenance of training curricula in ComplianceWire

Flexibility to accommodate a changing work schedule and sensitivity to international time zones is required.

Develop in-depth knowledge of department's research processes, policies, and procedures

Acquire knowledge of department organizational structure

Collaborate with administrative staff colleagues to ensure office efficiencies

Maintain Pharmaceutical Credo objectives

Assist with Purchase Order requests and processing

Provide other administrative support as assigned by the Associate Director.

Qualifications

A minimum of an associate degree is required. A bachelor's degree is preferred.

Experience with publication management systems (e.g., PUBSRAT, PubPro) is highly preferred

Basic understanding of research methodologies (in clinical/health preferred)

Knowledge in regulatory and/or compliance in health care industry (e.g., clinical research, trials, health outcomes research) is highly preferred

Basic understanding of scientific publication methodologies preferred

Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook, Adobe) is required

Ability to learn specialized computer (or Web-based) software used for document approval processes, training curricula, and other applications

Prior experience with creating standardized operating procedures is preferred

Must have excellent time management skills

Must have good verbal and written communication and interpersonal skills

Must have strong organizational skills, along with excellent judgment and reasoning abilities.

Must be a strong team player with the ability to coordinate with other HEMA associates and research partners

Ability to multi-task and work under minimal supervision, in a dynamic, fast-paced, multicultural, international environment is required.

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