The Senior Medical Writer (SMW) will Oversee the execution of scientific publications (ie, clinical manuscripts, abstracts, posters, and oral presentations) that fulfill medical/scientific objectives. They will draft and review medical publications and with knowledge of publication planning, processes, and requirements following industry standards such as International Committee of Medical Journal Editors (ICMJE) and Good Publication Practice (GPP 2022) guidelines. They will drive development of global strategic publication plans for priority and/or complex therapeutic areas, as assigned and provide oversight to other writers. They will represent Global Medical writing on organizational cross-functional teams, and lead/participate in department initiatives/activities that impact medical publishing practices/processes.
Responsibilities:
Create documents for all phases of drug development, including manuscripts, abstracts, posters, oral presentations, and slide sets through their lifecycle.
Independently write first drafts from study reports and/or source data, including primary and secondary analyses, with input from lead author.
Perform Project Management responsibilities including drafting and driving timelines, leading kick-off meetings, scheduling and leading meetings, and demonstrating excellent interpersonal and negotiation skills and flexibility.
Coordinate or complete journal/abstract submissions adhering to journal and congress requirements.
Manage and drive document reviews and address comments. Facilitate comment resolution discussions with internal and external authors.
Provide oversight of writers from different vendors that support multiple compounds and/or indications of a major or complex product within a therapeutic area, including oversight of work product and activities, ensuring accuracy and adherence to timelines and Publication Policy and associated Procedures. Critically reviews work and provides feedback to ensure scientific accuracy and strategic alignment.
Lead cross-functional Publications Team(s) for priority and/or complex therapeutic areas including Hematology, Transplant, Cardiovascular, Immunology, and Respiratory, as assigned. Lead team meetings/discussions and driving the development of publication strategy, incorporating input from key global stakeholders.
Demonstrate ability to communicate key and sensitive information to TA and senior leadership.
Communicate effectively across functional areas and within department to accomplish project objectives. Able to present information in a professional, concise, clear, and objective manner.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Implement systems or solutions to enhance efficiency, eliminate redundancy, reduce expenditure.
Provide professional guidance to authoring teams to ensure adherence to GPP 2022, ICMJE guidelines and other industry standards and best practices.
Obtain and retain required documentation for publication per client policies
Education, Experience, Training, and Knowledge:
PhD, MD, MPH, or PharmD required, or equivalent experience.
Minimum of 7+ years of experience as a professional medical writer who has contributed or written many medical publications, manuscripts, presentations and posters.
Advanced graphics capabilities to produce publication quality figures.
Experience with developing manuscript enhancements and extenders.
Experience with grant proposal writing is preferred.
Experience with medical information and educational materials is preferred.
Expert knowledge of regulations, requirements, policies, and guidelines that apply to the preparation and production of scientific publications.
ISMPP certification is Preferred
Skills & Abilities:
Proficient in Word, PowerPoint, Excel, and Adobe Acrobat; for developing and editing PowerPoint slides and PDF poster layouts. Advanced graphic capabilities a plus.
Knowledge validating publication guidelines and specifications, client publication policies and procedures, confidentiality, secure file transfer, copyright law, and privacy protection.
Excellent oral and written communication skills to work across an organization and facilitate discussions with clients, client authors, and KOLs within an industry.
Strong analytical skills to anticipate team needs, identify where
improvements can be made, and offer suggestions for making work more efficient.
Maintain industry knowledge, identify and adopt work practices that are the most effective to ensure consistency in performance for self and the team.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
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