BioMetrics
Description
The Medical Writer 1 applies basic to intermediate documentation preparation and document project management skills to assist in the development, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.
RESPONSIBILITIES
• Under the direction of the project lead Medical Writer, prepares and edits documents that meet project timelines and conform to global regulatory submission and internal document standards.
• Provides peer review and editing support for regulatory documents and may also provide editorial or review support for other types of documents, such as manuscripts or presentations, CRFs, or study materials.
• Assists in the preparation and distribution of documentation to the project team members.
• Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
• Works effectively with cross-functional groups within BioMetrics and the document development team.
• Other tasks as assigned.
SCOPE
This position progressively develops the medical writing function in alignment with the requirements of the BioMetrics department and organizational goals. Filling this need with a regular full-time employee will enable BioMarin to reduce writing-related CRO and contractor costs, increase BioMetrics productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications.
EDUCATION
Bachelor’s or higher degree preferred; scientific focus desirable.
Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing.
Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.
EXPERIENCE
Relevant Experience
Fulfills one of the following:
• Up to 2 years of as a medical writer in the pharmaceutical industry
• At least 5 years of medical or scientific writing experience as a primary job responsibility
Clinical Studies
• Familiar with the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for the conduct of clinical studies.
• Familiar with clinical study data collection and results reporting.
Medical Writing
• Intermediate to advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content.
• Intermediate to advanced applied knowledge of AMA, CBE, and Chicago Style Manuals.
• Ability to interpret basic tabular and graphical clinical data presentations.
• Ability to create basic tables using AMA style (eg, Schedule of Events).
• Intermediate applied knowledge of basic clinical laboratory tests.
• Advanced capabilities to research literature and interview subject matter experts to quickly gain familiarity with therapeutic area.
• Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).
• Basic understanding of biostatistical and clinical research concepts.
• Experienced with writing, reviewing, or editing protocols, Investigator Brochures, clinical study reports, case report forms, and informed consent forms.
Computer/office equipment Skills
• Proficient in Microsoft Word (including the use of templates), Excel, and PowerPoint.
• Basic Microsoft Project skills.
• Experienced with scanners, printers, and copiers.
Regulatory
• Basic knowledge of regulatory requirements and guidances associated with ‘standalone’ regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
Project Management
• Takes direction well.
• Capable of working on multiple tasks and shifting priorities.
• Motivated and shows initiative.
• Detail oriented.
• Intermediate applied knowledge of the principles of tracking and accurately compiling reviewer comments.
• Intermediate applied knowledge of managing document review/development in a team setting.
Communication
• Capable of well organized, concise and clear written and verbal communication.
• Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements.
• Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills.
https://www.ultirecruit.com/BIO1001/jobboard/JobDetails.aspx?__ID=*B97E6F7DC9743972
Tags:
Stats:
Item Location
Images
There are no images