Chera York
Emerald Isle,NC
Summary
Technical/Medical Writer with 10+ years of research, writing, and editing experience including advanced proficiency in evidence -based clinical research and regulatory research. Proven and capable communicator of scientific information to a targeted audience. A 2 year focus on medical writing and white paper publication. A 5 year focus on policy writing including clinical, reimbursement, and administrative medical policies for an MCO writing over 200 active medical policies. A 3 + year focus on writing SOPs and internal controls. Exceptional presentation, communication, and collaboration skills with all organizational levels. Leadership experience in oversight of regulatory and quality programs, including acting as a state liaison and overseeing regulatory submissions for state approval, additionally creating a compliance program for a new company and writing all company Internal Controls and SOPs for state approval. Also interested in writing wellness articles.
Overview
15
15
years of professional experience
Work History
Medical Writer
Magellan Health/ Prime Therapeutics
08.2021 - 08.2023
- Created industry white papers to educate and inform target audiences;
- Performed extensive and in-depth research including medical evidence-based data, clinical trial analysis, literature reviews, and regulatory and legislative research;
- Collaborated with SMEs across multiple departments including peer reviews requiring considerable content editing, clinical trial analysis, pharmacy drug summaries and content and graphics design and placement assessments;
- Managed white paper projects to ensure project objectives were met within set deliverable dates;
- Regularly presented research findings and project progress updates;
- Responsible for final proofing and editing of papers prior to website publication;
- Completed FDA Drug Recall applicability reviews including quality document reviews and collaboration with the Quality Department prior to sending documents to clients; and
- Developed SOPs and quality checklists for the Medical Writer position.
Medical Policy Writer
CareSource
04.2016 - 07.2021
- Wrote medical policies for Medicare, Medicaid, MyCare, and Marketplace products;
- Responsible for extensive and detailed research including medical literature, clinical studies, evidence-based databases, regulatory and legal;
- Presented medical policies to the Clinical Policy Committee, communicating complex clinical concepts to a broad audience in order to facilitate committee decisions;
- Worked with health plan business product leaders, specialty companies, and corporate leaders to develop deliverables on policy priorities;
- Reviewed existing policies on an annual basis and revised according to new evidence-based literature or regulatory guidelines;
- Proofread and edited policies for website publication or state submission;
- Ensured policies were compliant with local, state, and federal guidelines;
- Collaborated with SMEs to create policy positions, review new policies and revise existing policies;
- Worked closely with Reimbursement Policy Writers, Coding Analysts, Configuration Analysts and Medical Directors;
- Worked closely with Financial Analytics to strategically steer policy decisions;
- Reviewed and evaluated workflow projects, ensuring timely development of new and existing assignments;
- Maintained detailed summaries and tracking spreadsheets to ensure information is documented and projects were completed in a timely manner;
- Worked closely with the administrative team to ensure completed and approved policies were submitted to Marketing and applicable state markets for approval; and
- Supported operational processes of the Clinical Policy Committee as a voting member.
Compliance Manager - Internal Control & SOP Writer
Pinnacle Entertainment - Belterra Park Location
09.2012 - 01.2016
- Served as a liaison between the company and state regulators;
- Developed a system of Internal Controls for the organization, including formal submission and approval from governing agency;
- Developed and wrote system of SOPS across all departments;
- Collaborated with internal team members, outside agencies, program and project leads and department personnel;
- Provided all New Hire Orientation in regulatory required training;
- Provided all industry best practice compliance training;
- Reviewed and evaluated internal audit reports and evaluated department requests for revisions of Internal Controls and SOPs;
- Responsible for assuring management complied to all state, federal and local laws and administrative codes governing the gaming industry;
- Responsible for all formal responses, including company representation in compliance reviews regarding violations and sanctions;
- Hired, trained, and managed staff in Compliance Department;
- Implemented and monitored department standards, guidelines, and objectives, and maintained other administrative processes such as budget and staffing to ensure proper planning and efficient operation of department;
- Maintained a system of Internal Controls and SOPs, conducting routine audits for compliance;
- Submitted all corporate quarterly reports; and.
- Ensured timely submission of all permits and licenses.
Quality Assurance Manager
Cincinnati Eye Bank
04.2012 - 08.2012
- Administered the complete Quality Assurance Program for the Eye Bank;
- Prepared reviews of personnel, safety, facilities, instruments, reagents, and quality controls per policy, reporting findings to management;
- Prepared audit reports of QA activities for management; and
- Maintained current EBAA Medical Standards and FDA requirements.
Family Services Coordinator
Life Center OPO
03.2009 - 02.2011
- Primary liaison between hospital decision makers, families, and LifeCenter staff;
- Responsible for donor informed consent and execution of paperwork;
- Functioned as donor family advocate and responded to family concerns, questions, and needs, championing their rights and honoring their decisions;
- Built close cooperative relationships with key hospital staff to maximize partnership between LifeCenter and participating hospitals;
- Acted as a public educator creating public awareness and promoting LifeCenter's mission; and
- Created and maintained all written correspondence to families, hospitals and outside transplant centers, including: letters, updates, event invitations, and surveys.
Communications Specialist
Life Center OPO
09.2008 - 03.2009
- Provided education to communities in the Cincinnati area regarding organ and tissue donation;
- Worked with multiple outside institutions to insure timely follow-up to families, hospitals, and LifeCenter staff;
- Collected and maintained data according to company and UNOS policy, including proofreading and ensuring complete accuracy; and
- Acted as a liaison between donor families and staff to ensure timely and accurate management of each case.
Education
Bachelor of Arts - Communication Arts/Written Comm/Biological Science
Mount St. Joseph University
Cincinnati, OH 05.2006
Skills
Medical Writing
Policy Writing
Technical Writing
Research
Clinical Trial Analysis
Proofreading and Editing
Presentations and Public Speaking
Compliance and Quality Assurance
Hobbies
Interests include: yoga and wellness, travel, chocolate, nature conservation, ocean conservation, conchology, gardening and botany, and baking.
Timeline
Medical Writer
Magellan Health/ Prime Therapeutics
08.2021 - 08.2023
Medical Policy Writer
CareSource
04.2016 - 07.2021
Compliance Manager - Internal Control & SOP Writer
Pinnacle Entertainment - Belterra Park Location
09.2012 - 01.2016
Quality Assurance Manager
Cincinnati Eye Bank
04.2012 - 08.2012
Family Services Coordinator
Life Center OPO
03.2009 - 02.2011
Communications Specialist
Life Center OPO
09.2008 - 03.2009
Bachelor of Arts - Communication Arts/Written Comm/Biological Science
Mount St. Joseph University
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