![]() Review of team members work for style, strategy, content accuracy and data checking.Successfully managing client relationships and providing effective counsel to clients and leading formal client meetings.Content development for a wide range of meetings and stakeholder engagement programmes, such as steering committee meetings, advisory boards, and standalone educational meetings.Involvement in the design & implementation of targeted and systematic literature reviews, as well as evidence reviews and gap analyses.The creation of a wide range of documents, such as study protocols, study reports, publications and publication summaries, slide decks, and newsletters.Y our responsibilities will include (but are not limited to): The team is at a particularly exciting stage in its growth and development at present, so there is tremendous potential for you to really make your mark. ![]() This is a chance to work on a wide variety of written deliverables, meetings, and stakeholder engagement programmes, across a diverse range of therapy areas. Our industry-leading flexible working policy means you could be fully office-based, in London or New York, a hybrid worker, or even fully remote. Softworld has developed expertise across six distinct staffing and consulting practices over the past 25 years that include Technology Services, Life Sciences, Engineering, Government, Banking, and Creative Services.With strong growth year on year over the past 5 years, AXON’s Real-World practice has an outstanding opportunity for a Senior Medical Writer to join its dynamic, friendly, international team. Softworld, Inc., a 2018 Inavero Best of Staffing Award Winner for both talent and client satisfaction, is a multifaceted staffing and consulting firm with the experience and infrastructure to support clients and talent on a national level. Subcontracting is not available for this position. Applicants received from firms will not be considered. THIRD PARTY AGENCIES, SUBCONTRACTORS, AND RECRUITERS NEED NOT APPLY. * Good communication, interpersonal, and team skills. Microsoft office, and expertise with EndNote or equivalent. * Experience working with different document management tools, ie. * Minimum 4-6 years relevant professional experience in Medical Writing. * Knowledge and understanding of the clinical research process, including ICH GCP, and FDA/EMA/NMPA guideline for clinical study. Publications in the international journals as the first author would be a plus. * Master's degree or above, majoring in medicine, pharmacy, or life science related disciplines. * May oversee external vendors to provide writing service for internal AHT projects. * Arranges and conducts review meetings with team, and coordinates responses to inquiries, questions, and deficiencies received from submission reviewers. * Acts as interface to resolve issues and questions arising during writing process. * Communicates deliverables needed and writing process to team members. * Utilizes submission templates (if available) or format/style guidelines (if available) according to related SOP. * Serves as the Medical Writing representative on product teams. * Relative Clinical/regulatory review documents ![]() Top Required Skills - 5 years industry experience, focus on medical writing oncology, small molecule, IND & NDA experience, provide guidance to internal medical/clinical science teamīe responsible for preparation of key clinical documents for regulatory submissions and other documents not limited to below: ![]()
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