In August 2017, I saw an advertisement published for a medical writer. Is this what you want to do?
If so, the Medical Writing Institute can help you work on documents and become expert at them. If not, the Medical Writing Institute can work with you, determine what you are good at, and help you in a different direction in the international health industry.
If not, the Medical Writing Institute can work with you, determine what you are good at, and help you in a different direction in the international health industry.
The advertisement, I edited it as much as I could. They have used a lot of words to say that they want a medical writer who has a proven track record writing documents for regulatory agencies (FDA, EMEA), who can look at masses of data and determine if they were correctly analyzed, who understands the scientific background of the product that needs to get regulatory agency approval, and who will not sink other products that the company has been given tons of money to run clinical trials.
What they are really saying is that because of the labor laws in this country, and the ease with which employers fire employees, medical writers have no loyalty to any company, and they are not going to train anyone to be a medical writer who will jump ship the minute they get a better job offer. Here it is:
Medical Writer for a Contract Research Organization
Medical writers are responsible for development of medical writing deliverables that support the Client’s clinical regulatory writing portfolio. They work with minimal guidance and oversight to achieve goals, and are expected to be well experienced in clinical regulatory writing.
• Reports to company management with day-to-day direction from the client
• Liaises with other company profesionals and vendors as appropriate
• Functions as scientific contributor and subject matter expert in preparation of selected regulatory clinical documentation
• Applies developing knowledge of regulatory medical writing and therapeutic area or investigational product to support other company projects
• Participates as part of the medical writing team in cross-functional teams
• Demonstrates competence in writing, editing and reviewing of clinical study reports, investigator brochures, registration dossier modules, and other clinical regulatory documents in line with expectations
• Able to interpret data and apply knowledge of scientific background and agency regulations when preparing documents
• Manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings
• Works collaboratively with colleagues in other ares of the company to achieve results
• Solves problems associated with medical writing scope of work, seeks advice from management and others as needed and exercises negotiation and communication skills with project team members
• Completes training assigned by the client and the company as necessary, including general training requirements, standard operating procedures, and system and process related training
• Follows closely company and client standard operating procedures and processes
Training and Education:
• Bachelor’s degree in Life Sciences with 8+ years; or MS with 4+ years; or PhD with 3+ years of relevant career experience
• 3-8 years of experience as a medical writer preparing regulated documents on drugs, devices and biological products in the international health industry
• Ability to prepare, with minimal supervision a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines
• Participate actively in medical writing and cross-functional project teams
• Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management
• Excellent oral (including presentation) and written communication, and project management skills
• Awareness of pharmaceutical industry needs beyond clinical development”