The Assoc Medical Writing Director 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 10 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.
- Expert knowledge of regulations, requirements, policies, and guidelines that apply to the preparation and production of scientific publications.
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 advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at https://jobs.iqvia.com
We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe
IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status. https://jobs.iqvia.com/covid-19-vaccine-status
The potential base pay range for this role, when annualized, is $124,400.00 - $211,900.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.