Medical Writer II

Other

Posted 26 days ago


Job description

Responsibilities:
  • Defines scope of quality control activities with the document author and the required source documents and data required.
  • Conducts independent quality control review of documents per applicable checklist by checking against source documents to ensure results are accurate.
  • Ensures quality control documentation is complete and accurate and uploaded to the master file per the established business processes.
  • Maintain strong knowledge of clinical regulatory documents requiring quality control review and business processes.
  • Interacts daily with medical writers and/or medical writing managers and interfaces/communicates with applicable cross-functional areas.
  • Communicates and provides deliverables to medical writers, medical writing managers, and others as applicable.
Requirements:
  • Bachelor's degree required.
  • Bachelor's degree in science, English, or Communication preferred.
  • 2-3 years in relevant industry experience in quality control/review of clinical regulatory documents or related experience in an area such as quality assurance, clinical research, drug development, medical writing, regulatory, or product support/R&D. Note: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.
  • Excellent knowledge of organization and content of clinical documents and eCTD structure.
  • Knowledge of drug development and experience with Common Technical Document (CTD) content templates.
  • Excellent oral/written communication, interpersonal/organizational, analytical/critical thinking, and conflict management skills.
  • Superior attention to detail and ability to prioritize multiple tasks/projects.
  • Experience in working with collaborative cross functional teams.
  • Operates with limited oversight.
  • Prepares technical documents to support both domestic and international regulatory submissions.
  • Incorporates text, graphs, charts, tables and statistical analysis.
  • Proofreads, circulates, edits, assembles, inspects and duplicates product submissions.
  • Experience Level = 3-5 Years.

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About Katalyst Healthcares & Life Sciences

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Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.

Industry

Scientific research and development services

Company size

51 - 200 Employees

Headquarters location

South Plainfield, NJ, US

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Frequently asked questions

Q: What skills or qualities help someone succeed as a Medical Writer?

A: To succeed as a Medical Writer, key technical skills include a strong understanding of medical terminology, pharmacology, and regulatory guidelines such as FDA regulations and ICH guidelines. Soft skills like excellent communication, attention to detail, and the ability to distill complex scientific information into clear, concise language are also crucial. These strengths enable Medical Writers to effectively convey critical information to various audiences, from healthcare professionals to patients, and support their career growth by fostering a reputation for accuracy and clarity.

Q: What is the career path for a Medical Writer?

A: A Medical Writer's typical career progression involves starting as an Entry-Level Medical Writer, where they assist in creating content for pharmaceutical companies, medical device manufacturers, or healthcare organizations. As they gain experience, they can move into Mid-Level roles such as Senior Medical Writer or Medical Communications Specialist, where they lead content development, manage teams, and develop strategic communication plans. Ultimately, Senior Medical Writers can advance to roles like Medical Director or Scientific Communications Lead, overseeing large-scale content initiatives and mentoring junior writers, or transition into related fields like Regulatory Affairs, Clinical Research, or Science Publishing.



Katalyst Healthcares & Life Sciences job posting for a Medical Writer II in San Francisco, CA with a salary of $41 to $69 Hourly with a map of San Francisco location.