Medical Writer jobs in Kentucky

I
Principal Medical Writer - Home-Based (US/Canada)
  • ICON Strategic Solutions
  • Canada, KY FULL_TIME
  • ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

    • Lead, manage, and coordinate all internal and external writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally.
    • Oversee and manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.
    • Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and AMA Medical Writing styles, as applicable, in adherence with study/project timelines and corporate objectives.
    • Actively participate in study and/or project team meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
    • Administrate as appropriate, the receipt, collation, and incorporation of review comments needed for the completion of regulatory documents.
    • Lead or participate in defining and writing standard operating procedures and working practices which will allow the effective and efficient preparation of quality.
    • Lead or participate in cross-functional process improvement initiatives.
    • Mentor more junior medical writing staff.


    Responsabilités
    • Agir en tant que rédacteur médical principal pour de nombreux programmes, projets et études individuelles d’un niveau de complexité modéré à élevé.
    • Rédiger et réviser des protocoles/amendements aux protocoles, des synopsis de protocoles, des rapports d’études cliniques, des brochures pour chercheurs (IB)/mises à jour d’IB, des soumissions réglementaires (y compris les composantes cliniques et non cliniques des IND, NDA, BLA, MAA, etc.), et d’autres documents de recherche clinique et/ou de post-marketing. Préparer des manuscrits scientifiques si nécessaire.
    • Fournir des conseils en matière de rédaction scientifique et médicale aux clients et aux collègues internes à un niveau de complexité élevé.
    • Diriger les équipes de projet dans la rédaction des spécifications des rapports, la rédaction médicale et la coordination des soumissions réglementaires et de l’analyse des données, le cas échéant.
    • Servir de mentor actif auprès du personnel à tous les niveaux hiérarchiques.
    • Superviser les activités opérationnelles des autres employés en tant que chef d’équipe du projet.
    • Élaborer et mettre en œuvre des formations pertinentes.
    • Dispenser une formation transversale en cours d’emploi, en interne et pour les clients, dans les domaines d’expertise thérapeutique et/ou technique.
    • Participer aux audits externes et internes.
    • Fournir des estimations d’offres pour les projets potentiels et assister aux réunions de défense des offres lorsque cela est demandé.
    • Agir en tant que membre de groupes d’amélioration des processus et de groupes d’intérêt.
    • Participer à d’autres activités non facturables, selon les besoins, et accomplir toute autre tâche jugée appropriée par l’équipe de gestion du département.

    • A Bachelor's degree in a life science discipline, with Master's degree in life science
      discipline preferred.
    • At least 6 years writing experience in the biopharmaceutical/CRO industry required.
    • Proficient understanding and knowledge of domestic and international regulatory requirements required and knowledge of therapeutic areas in all phases of clinical development desired.
    • Proficiency in organizing and communicating clinical information necessary.
    • Strong communications, organizational, time management, and project management skills are required.
    • Proficient in MS Word. and experience with template systems (eg, StartingPoint).
    • Experience with an electronic document management system (eg, MasterControl,
    • Documentum) and use of templates preferred.
    • Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.


    Qualifications
    • Être titulaire d’un diplôme de baccalauréat dans un domaine scientifique, lié à la santé ou au journalisme/à la communication. Diplôme d’études de deuxième ou troisième cycle préférablement.
    • Posséder 8 ans d’expérience pertinente ou une combinaison équivalente d’études, de formation et d’expérience pertinente.
    • Démontrer d’excellentes compétences en communication écrite et orale et en présentation en anglais américain.
    • Posséder de solides compétences dans la rédaction de sections techniques de documents réglementaires et/ou scientifiques, tels que, sans s’y limiter, les protocoles/modifications de protocoles, les synopsis de protocoles, les rapports d’études cliniques, les brochures pour les chercheurs (IB)/les mises à jour des IB, les soumissions réglementaires (y compris les composantes cliniques et non cliniques des IND, NDA, BLA, MAA, etc).
    • Accorder une grande importance aux détails.
    • Posséder une excellente connaissance des exigences de style énoncées dans le AMA Manual of Style, 10 th
    • Démontrer des habiletés de haut niveau dans la résolution de problèmes et l’interprétation d’analyses statistiques complexes.


    What ICON can offer you:

    Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

    In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

    Our benefits examples include:
    • Various annual leave entitlements
    • A range of health insurance offerings to suit you and your family’s needs
    • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
    • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
    • Life assurance
    • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others


    Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

    ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

    If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

    Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
  • 6 Days Ago

M
Writer
  • Mediabistro
  • Barbourville, KY FULL_TIME
  • Mondelez International - JobID : 0C60113AA37941E2B4042E2676AA8F15 Retail Merchandiser / Visual Merchandiser As a Nabisco Merchandiser / Order Writer at Mondelez International, you'll : Physically move...
  • 21 Days Ago

M
Writer
  • Mediabistro
  • Ashland, KY FULL_TIME
  • Stock to ensure full-shelf conditions, neatly-merchandising displays and shelves; Build display point-of-sale in all areas of the store, and rotate product...Hiring Immediately > Last updated : 2024-0...
  • 21 Days Ago

O
Writer
  • Outlier AI
  • Lexington, KY FULL_TIME
  • Outlier helps the world’s most innovative companies improve their AI models by providing human feedback. In this role, you will become an AI coach of sorts, assessing the quality of AI-generated writi...
  • 11 Days Ago

O
Writer
  • Outlier AI
  • Bowling Green, KY FULL_TIME
  • Outlier helps the world’s most innovative companies improve their AI models by providing human feedback. In this role, you will become an AI coach of sorts, assessing the quality of AI-generated writi...
  • 11 Days Ago

M
Writer
  • Mondelēz International
  • Ashland, KY FULL_TIME
  • Description Join our Mission to Lead the Future of Snacking AT Mondelēz International Full Time Nabisco Merchandiser / Order Writer Join our team of Full Time Nabisco Merchandiser / Order Writers and ...
  • 1 Month Ago

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Medical Writer
  • LanceSoft
  • Titusville, NJ
  • Title: Plain Language Summary Writer/Medical Writer/Clinical Writer Location: Titusville, NJ 08560 (Remote) Duration: 06...
  • 3/28/2024 12:00:00 AM

M
Principal Medical Writer
  • MMS
  • Richmond, VA
  • MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, including clinical trial transparency,...
  • 3/28/2024 12:00:00 AM

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Medical Writer
  • Randstad Life Sciences US
  • Title: Medical Writer Location: Remote | based in IL Pay: $50-59/hr Contract: 12+ months Summary The Senior Medical Writ...
  • 3/26/2024 12:00:00 AM

A
Medical Writer
  • Ascentage Pharma
  • Rockville, MD
  • Company Summary: Ascentage Pharma is a globally focused biopharmaceutical company engaged in developing novel therapies ...
  • 3/25/2024 12:00:00 AM

R
Medical Writer
  • Randstad Life Sciences US
  • Northbrook, IL
  • A major Pharmaceutical company “Contribute toward improving the health of people around the world through the provision ...
  • 3/25/2024 12:00:00 AM

S
Medical Writer
  • Source One Technical Solutions
  • Source One is a consulting services company and we’re currently looking for the following individual a Technical Writer ...
  • 3/25/2024 12:00:00 AM

R
Medical Writer
  • Randstad Life Sciences US
  • Waukegan, IL
  • Medical Writer III 3 Months Waukegan, IL (Onsite preferred, Open to remote) PR: $50 - $59.86/hr Job Description Prepares...
  • 3/25/2024 12:00:00 AM

F
Medical Writer
  • Flywheel Partners
  • New York, NY
  • DESCRIPTION Training + Communications + Healthcare. We have an immediate opening for a full-time, entry-level Writer & C...
  • 3/24/2024 12:00:00 AM

Kentucky (/kənˈtʌki/ (listen) kən-TUK-ee), officially the Commonwealth of Kentucky, is a state located in the east south-central region of the United States. Although styled as the "State of Kentucky" in the law creating it, (because in Kentucky's first constitution, the name state was used) Kentucky is one of four U.S. states constituted as a commonwealth (the others being Virginia, Pennsylvania, and Massachusetts). Originally a part of Virginia, in 1792 Kentucky became the 15th state to join the Union. Kentucky is the 37th most extensive and the 26th most populous of the 50 United States. Ke...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Medical Writer jobs
$83,955 to $103,666

Medical Writer
Attend on-site client meetings, listening to their needs, offering your feedback, and building a level of trust that will ensure future commitments.
April 21, 2023
Negotiates with cross-functional areas on project outcomes and deliverables to meet conflicting demands.
April 15, 2023
Participates in core process steps for systematic literature reviews including search, screen, data extraction, analysis, and synthesis of the literature for CER processes.
January 27, 2023
Determines scope of QC review with the document author and the source documents and/or data required (in addition to utilizing any applicable checklist).
December 31, 2022
Communicates with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the CER process to identify the necessary clinical and technical information for as
November 22, 2022
Medical Writer in Virginia Beach, VA
Functional knowledge of Biostatistics - Accurate description and presentation of clinical trial methods, statistical parameters, and medical data.
January 27, 2023
Medical Writer
Contribute to account plans, strategic publication plans and publication programs, where appropriate, by maintaining current awareness of developments in therapeutic area or discipline and the Springer Healthcare product portfolio.
May 02, 2023