Job Description
Target PR Range: 57-67/hr
*Depending on experience
Position Summary: The primary responsibilities of an Associate Director Medical Writer at include, but are not limited to, leading key medical writing projects and activities across therapeutic areas and preparing (under minimal supervision) scientific and regulatory documents related to the clinical development of investigational and marketed drugs and biologics. These types of scientific and regulatory documents can include clinical study reports (CSRs), subject narratives, clinical investigator brochures, protocols, briefing documents, and sections of Investigational New Drug Applications (INDs) and New Drug Applications (NDAs)/Biologics License Applications (BLAs) (i.e., integrated summaries of safety and efficacy, product labeling, and summaries and overviews of nonclinical and clinical information). The Associate Director Medical Writer has a broad range of experience in pharmaceutical medical writing and clinical/pharmaceutical development and knowledge of current regulatory guidelines. Primary Responsibilities: • Acts as medical writing point person for production of preclinical summaries, clinical summaries, pharmacokinetic reports, safety summaries, literature reviews, and other documents needed for regulatory submissions. • Participates in and contributes to the development of the submission communication strategy for a product. • Interprets and summarizes data from biostatistical summary tables and listings accurately, precisely, and concisely into narrative text. • Liaises with internal groups, i.e., Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, Clinical Development, Clinical Operations and R&D Management to obtain necessary information and to ensure the timely implementation of activities related to the production of reports. • Interacts with and oversees, coordinates and reviews the work of other medical writers, including freelance/contract medical writers and agencies, with support from Director Medical Writing. • Fosters innovation and improvement related to medical writing processes and documents, with support from Director Medical Writing. • Other responsibilities as assigned. Scope: Uses professional concepts and company objectives to resolve complex issues in creative and effective ways, exercising judgment in selecting methods, techniques and evaluation criteria for obtaining results. Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Determines methods and procedures on new assignments. Physical Requirements: While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Occasional overnight travel may be required.
Skills:
Skills: American Medical Writing Association (AMWA) certification or other is desirable, with a specialty in Pharmaceutical Writing. Preferred experience includes: • 3+ years’ in medical writing for the pharmaceutical industry, with a focus on regulatory document preparation; knowledge of drug development process and regulatory guidelines. • Specific experience working with CNS/Neuroscience compounds. • Ability to manage projects independently and lead/organize/participate in cross-functional teams. • Journalism/press publications. Must possess: • Strong writing skills and the ability to convert scientific data into a clear, scientifically sound, well-structured ‘story’. • Ability to self-edit and improve own work to ensure readability, accuracy, consistency and aesthetic presentation of data and information. • Knowledge of clinical trial and drug development processes. • Knowledge of and/or ability to quickly assimilate US, ICH and international regulations, requirements and guidance associated with scientific and clinical/regulatory document preparation and submissions. • Knowledge of Common Technical Document content templates as well as content expectations for IND/NDA/MAA and other regulatory documentation. • Working knowledge of current electronic document management systems and publishing systems. • Ability to assimilate, interpret and translate information/data for appropriate audiences. • Excellent working knowledge of software programs in Windows environment with high proficiency in word processing, flow diagrams, and spreadsheets. • Ability to learn fast, grasp the 'essence' of a story quickly to convert relevant scientific data/information into high quality summaries and reports. • Open to feedback and suggestions and innovation for improvement. • Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization. • Skilled at creating a cooperative team environment. • Able to objectively evaluate situations and make recommendations for changes in light of overall project demands.
Education:
A PhD in a life science/Pharm D preferred with 5 or more years of relevant experience; MS with 7 or more years of relevant experience.
Job Tags
Remote job, Contract work, Work at office, Night shift,