Ebony Kennedy, PharmD
Medical Information Writer at Moderna- Claim this Profile
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Bio
Experience
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Moderna
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United States
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Biotechnology Research
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700 & Above Employee
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Medical Information Writer
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Nov 2022 - Present
Remote • Serve on the Medical Writing team, independently authoring a variety of standard response documents for educational purposes, including standard response letters (SRLs), Unique Response Letters (URLs), Frequently Asked Question (FAQs), and other medical documents for reactive use. • Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate, and fair-balanced documents. • Plan, coordinate, and oversee review process of documents as well as… Show more • Serve on the Medical Writing team, independently authoring a variety of standard response documents for educational purposes, including standard response letters (SRLs), Unique Response Letters (URLs), Frequently Asked Question (FAQs), and other medical documents for reactive use. • Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate, and fair-balanced documents. • Plan, coordinate, and oversee review process of documents as well as uploading approved versions to various Medical Information systems. • Plan and coordinate timelines to ensure timely completion of global and regional writing projects. • Manage timelines and communicate with team stakeholders to maintain awareness of expectations, milestones, and deliverables. • Manage significant workstreams that involve work across departments or with external vendors. Show less
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Med Communications, Inc.
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United States
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Business Consulting and Services
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100 - 200 Employee
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Content Medical Information Specialist
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Nov 2021 - Nov 2022
Remote • Develop and review content for scientific documents including standard responses and dossiers. • Demonstrate ongoing scientific expertise relevant to therapeutic areas, including products, disease state management, and emerging therapies. • Integrate scientific expertise with knowledge of regulatory and compliance guidelines to ensure comprehensive review of materials submitted into approval process. • Create and review and medical affairs materials. • Apply approved standards of… Show more • Develop and review content for scientific documents including standard responses and dossiers. • Demonstrate ongoing scientific expertise relevant to therapeutic areas, including products, disease state management, and emerging therapies. • Integrate scientific expertise with knowledge of regulatory and compliance guidelines to ensure comprehensive review of materials submitted into approval process. • Create and review and medical affairs materials. • Apply approved standards of style to created and maintained materials. • Demonstrate proficiency in the use of content management systems as applicable. • Maintain active role in the Quality Assurance process. Show less
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The Scienomics Group
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United States
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Advertising Services
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1 - 100 Employee
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Medical Associate
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Jun 2021 - Oct 2021
Remote • Engaged in promotional content development for clients at all stages, including outline development, drafting, revision, annotation, and updating. • Prepared content ahead of advisory boards (agenda and presentation deck) as well as after advisory boards (topline and executive summaries). • Collaborated within a cross functional team including accounts and client services. • Prioritized various client tasks to meet client deadlines.
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Sarepta Therapeutics
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United States
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Biotechnology Research
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700 & Above Employee
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Medical Information Writer
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Nov 2020 - May 2021
Remote • Wrote over 50 new and updated standard response documents covering rare disease(s). • Performed routine and ad hoc literature monitoring/searching for department database and strategic projects. • Engaged daily with vendor contact center staff, offering guidance on complex inquiries, as well as ad hoc product training. • Assisted with update and review of joint operational guidelines used with vendor contact call center staff and/or other departments within the company. •… Show more • Wrote over 50 new and updated standard response documents covering rare disease(s). • Performed routine and ad hoc literature monitoring/searching for department database and strategic projects. • Engaged daily with vendor contact center staff, offering guidance on complex inquiries, as well as ad hoc product training. • Assisted with update and review of joint operational guidelines used with vendor contact call center staff and/or other departments within the company. • Supported launch activities following FDA approval of new therapy in Duchenne muscular dystrophy. Show less
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PrimeVigilance
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Medical Information Associate
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Oct 2019 - Nov 2020
Waltham, Massachusetts • Managed parallel client projects, organized client meetings, and served as a liaison to facilitate communication between clients and my colleagues. • Maintained FAQs and Standard Response Document repository. • Trained eight new hires on client specific tasks and medical information processes. • Wrote and updated joint operating guidelines and training materials for use by MI call center agents. • Reviewed inquiry responses and inquiry documentation from colleagues for quality… Show more • Managed parallel client projects, organized client meetings, and served as a liaison to facilitate communication between clients and my colleagues. • Maintained FAQs and Standard Response Document repository. • Trained eight new hires on client specific tasks and medical information processes. • Wrote and updated joint operating guidelines and training materials for use by MI call center agents. • Reviewed inquiry responses and inquiry documentation from colleagues for quality and compliance purposes as a team lead. • Responded appropriately to unsolicited medical information inquiries received via phone, email, and fax using approved documents covering pulmonary, ophthalmologic, and rare disease states. • Accurately identified, documented and reported adverse events, pregnancy and other special situations, as well as product quality complaints. Performed follow up on these events as requested.
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Medical Information Associate
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Aug 2018 - Oct 2019
Waltham, Massachusetts • Responded appropriately to unsolicited medical information inquiries received via phone, email, and fax using approved documents covering pulmonary, ophthalmologic, and rare disease states. • Accurately identified, documented and reported adverse events, pregnancy and other special situations, as well as product quality complaints. Performed follow up on these events as requested. • Reviewed inquiry responses and inquiry documentation from colleagues for quality and compliance… Show more • Responded appropriately to unsolicited medical information inquiries received via phone, email, and fax using approved documents covering pulmonary, ophthalmologic, and rare disease states. • Accurately identified, documented and reported adverse events, pregnancy and other special situations, as well as product quality complaints. Performed follow up on these events as requested. • Reviewed inquiry responses and inquiry documentation from colleagues for quality and compliance purposes. • Maintained FAQs and Standard Response Document repository.
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RITE AID
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Retail
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700 & Above Employee
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Pharmacy Manager
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Jan 2017 - May 2018
Greenville, North Carolina Area • Oversaw hiring and training of pharmacy personnel. • Liaised between district manager and staff pharmacist to fill about 180 prescriptions daily as well as coordinate pharmacy objectives and maintain a quality pharmacy. • Maintained pharmacy within company, state, and national regulatory requirements. • Provided direct patient care to diverse population via patient counseling and point of care services (adherence checks, immunization review, medication therapy management). •… Show more • Oversaw hiring and training of pharmacy personnel. • Liaised between district manager and staff pharmacist to fill about 180 prescriptions daily as well as coordinate pharmacy objectives and maintain a quality pharmacy. • Maintained pharmacy within company, state, and national regulatory requirements. • Provided direct patient care to diverse population via patient counseling and point of care services (adherence checks, immunization review, medication therapy management). • Responded to inquiries from patients, nurses, and doctors with accurate, unbiased clinical information. • Managed a staff of pharmacy technicians.
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Staff Pharmacist
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Sep 2015 - Dec 2016
Greenville, North Carolina Area • Provided direct patient care to diverse population via patient counseling and point of care services (adherence checks, immunization review, medication therapy management). • Responded to inquiries from patients, nurses, and doctors with accurate, unbiased clinical information. • Managed a staff of pharmacy technicians.
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Staff Pharmacist
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Jun 2014 - Aug 2015
Gastonia, North Carolina • Provided direct patient care to diverse population via patient counseling and point of care services (adherence checks, immunization review, medication therapy management). • Responded to inquiries from patients, nurses, and doctors with accurate, unbiased clinical information. • Managed a staff of pharmacy technicians.
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Education
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UNC Eshelman School of Pharmacy
Doctor of Pharmacy (PharmD), Pharmacy -
University of North Carolina at Chapel Hill
Bachelor of Science (BS), Pharmaceutical Sciences