Analyst 2 - Quality Systems Document

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. 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.

Job Title: HEMA Processes Coordinator
Duration: 12+ months contract on W2
Location: Cincinnati, OH / Remote
20 hours per week

Manager would prefer HYBRID, but for a great candidate would accept REMOTE.
Part-time: flexible with the hours, prefer 4 hours a day, if a meeting in the morning at 8am they would need to be able to attend the 8am meeting

Description:
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.

Contact:
Sharath Babu: sharath.b@sunrisesys.com | (732) 395-4575 | URL: www.sunrisesys.com