Title: Medical Writing Publications Manager
Location: MD Gaithersburg - Corporate Headquarters
Major Duties and Responsibilities (including supervising others):
• Ensures the timely presentation/dissemination of clinical data from investigational pipeline products according to budget timelines strategic publication plans and tactical approaches.
• Ensures that strategically aligned scientific communication points are delivered and that statements and conclusions in publications (manuscripts abstracts posters oral presentations etc.) are accurate and supported by appropriate data.
• Oversees the entire publication development process working closely with authors thought leaders medical writers and other cross-functional publication team members.
• Ensures the quality and transparency of clinical publications by maintaining and promoting familiarity with ICMJE CONSORT AMA and other external standards as well as MedImmune’s publication policy and procedures.
• Creates and maintains publication records in the e-publication system and related files in the document management system ensuring that all author feedback and publication versions are archived.
• Leads cross-functional publication development team meetings and communications among team members.
• Participates in the development of strategic publication plans and tactics attends publication planning team meetings.
• Manages contract resources in the development of publications to meet objectives in a cost efficient and timely manner effectively using project management skills.
• Develops and actively manages relationships with journals sponsor congress organizations and publishers; prepares cover letters and response to journal letters and submits publications for review.
• Creates publication timelines and provides regular publication project status reports to Director Publication Writing and to publication planning teams.
• Develops and improves industry best practice in publication management; participates in the preparation or revision of SOPs and WPDs.
• Oversees the maintenance of database of bibliographic references across assigned therapeutic areas.
• 5+ years writing/editing publication experience in pharmaceutical industry communications agency or academic setting relevant to clinical publication development.
• Lead author of 8+ clinical/scientific publications or formal medical writing acknowledgment in 8+ clinical publications.
• Previous experience with management of publication-related vendors required; supervisory experience for direct reports a plus
• Strong track record (5+ years) in publication management required.
• Previous experience writing and editing peer-reviewed clinical publications (manuscripts abstracts posters oral presentations review articles etc.) required.
• Demonstrated ability to manage several projects simultaneously.
• Ability to analyze critically and synthesize complex scientific information from a broad range of scientific disciplines and clinical therapeutic areas.
• Ability to think strategically; demonstrated negotiating skills and resourcefulness.
• Demonstrated leadership qualities to gain credibility and influence cross-functional publication teams and external authors and thought leaders; high degree of influencing skills in shaping and developing publication content and wording.
• Demonstrated ability to make effective decisions even in the absence of complete information and when under pressure.
• Demonstrated ability to drive performance—holds others accountable for high standards and clarifies what needs to be accomplished and the consequences for the individual and/or the organization.
• Demonstrated ability to work collaboratively—seeks input and demonstrates an appreciation for diverse views by incorporating them into decisions/proposals.
• MS degree in a biomedical discipline required; doctorate level (PharmD MD or PhD) preferred.
• AMWA BELS and/or ISMPP certification a plus.
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