The Senior Medical Writer is responsible for preparing clinical study documents and sections of regulatory submissions. The Senior Medical Writing Scientist may assist other Medical Writing staff to prepare more complex documents and may assist with developing documents produced by other departments. The Senior Medical Writing Scientist contributes scientific knowledge and analytical skills to the preparation of clinical regulatory documentation. Works under minimal supervision.
KEY RESPONSIBILITIES: - Prepare moderately complex clinical regulatory documents, including clinical study protocols, clinical study reports, investigators brochures, and sections of regulatory submissions - Serve as the lead Medical Writing Scientist for moderately complex clinical studies - Support Medical Lead with review and interpretation of clinical study data and addressing questions from study team members - May coordinate Medical Writing resources for a clinical development program - Participate in developing key messages for moderately complex clinical regulatory documents - May represent the Medical Writing department on teams responsible for defining the direction and regulatory strategy for a clinical development program - Ensure medical and scientific consistency between related documents or studies in a clinical program - Thoroughly analyze and critically interpret data to determine the best approach to composing each document - Provide more advanced input for study designs, analysis plans, and statistical output - Provide advanced review of documents - As part of a cross-functional team, contribute to product development plans (e.g., provide information from previous studies, provide scientific input, integrate and review data) and serve as coordinating author for product development plans - Provide input and support for advisory board meetings for clinical development programs - May assist in preparing grant applications - Participate in developing standard operating processes and related procedures - Manage contract medical writers - May train, mentor, or supervise staff in the Medical Writing department - Perform other duties as assigned
The Successful candidate will have: - Ph.D. (or equivalent degree) and 2 \" 5 years of relevant work experience - Superior written communication skills - Experience writing and editing clinical regulatory documents - Ability to analyze, interpret, and summarize moderately complex data - Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology. - Ability to manage project teams, form productive working relationships, and work through conflicts - Excellent project management and organizational skills - Ability to prioritize and manage multiple complex projects - Ability to complete work in a resourceful, self-sufficient manner and design alternative approaches to achieve desired results, with some guidance and mentoring on new or complex issues. - Initiative and creativity in solving routine problems that affect multiple documents and in identifying and contributing to improvements in cross-functional process - Advanced computer skills related to word processing, templates, table/figure creation, literature searches, electronic review systems, and document management systems; can act as a resource for others for these tools. Associated topics: hematopathology, laboratory, medical technologist, microbiology, scientist, services, sterile processing technician, technician iii, technician iv, technologist
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.