Online Medical Training
i am looking for speakers/experts for online training in the below areas:
if you are interested, please leave your contact details and convenient time to connect.
rahul+30 Other Responses
Job title: manager, medical writing
group : medical writing
reports to: title executive vice president, chief scientific officer
the manager of medical writing is responsible for smooth functioning of all medical writing projects for clients and project teams through management of internal staff and the medical writing process. The manager, medical writing, maintains optimal department processes, implements project-specific strategies, and assists with the development and implementation of department strategies to increase productivity and quality.
The manager of medical writing assists with the oversight of medical writing personnel, including hiring personnel, managing personnel matters, and conducting performance evaluations for relevant staff. The manager of medical writing will be involved in training medical writing staff regarding applicable regulatory guidelines and medical writing practices. The manager also assists with resource allocation and with the development of business proposals related to medical writing functions.
The manager of medical writing serves as the lead medical writer on projects. As the lead medical writer, drafts and finalizes documents necessary for all phases of clinical drug and device development by organizing, analyzing, and interpreting scientific and statistical data. Such documents include, but are not limited to, clinical study reports, study protocols, investigator’s brochures, and manuscripts.
• works with project manager to develop timelines and resource plans for the production of clinical documents.
• reviews statistical analysis plans and case report forms as required.
• performs “peer” and quality control (qc) review of clinical study reports and clinical sections of regulatory submissions written by other medical writers.
• keeps management informed on progress of documents and other project related information, assists management in projecting resources, and performs administrative duties as requested.
Documents are to be completed within a time period that supports project needs and deadlines. Furthermore, documents are to be of high quality and scientifically accurate, and are to reflect a consensus among team members that is acceptable to all appropriate reviewers. Documents must meet international conference on harmonisation (ich) guidelines and company document standards unless required otherwise by client and agreed per procedure.
• the manager of medical writing has a bs/ba or advanced degree, with some applied training relevant to the clinical trials or health research environment, and at least 5 years medical writing experience in a cro, pharmaceutical, and/or biotechnology setting. Management experience preferred.
• thorough knowledge of international conference on harmonisation (ich) good clinical practice (gcp) guidelines and other applicable regulatory rules and guidelines as well as of medical terminology, clinical trials, and clinical research.
• excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with moderately complex statistical methods that apply to phase i-iv clinical trials are required.
• working knowledge of the relationship and regulatory obligation of the contract research organization (cro) industry with pharmaceutical / biotech companies.
• demonstrated ability to lead by example, and demonstrated skill for technical and supervisory leadership of staff.
• skilled in use of computer software, including microsoft word and microsoft excel, and ability to learn new applications.
• excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment.+6 Other Responses
Life Sciences Online Training
We are a leading provider of educational webinars for the international life sciences community and we are looking for independent u.S.-based consultants/subject matter experts with a minimum of 10 years hands-on industry experience to provide interactive, online training for the pharmaceutical, biotech and/or medical device industry.
Must have proven experience in instructional design and content development and be well versed in adult learning principles. This position may lead to a long-term contract.+24 Other Responses