The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world. As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We’re changing lives for a living. Are you ready to make a difference?
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The Position
The Manager - Publications works with minimal direction from a Director Level Team Member on the efficient and compliant development and execution of NNI publication plan(s) across assigned therapies and therapeutic areas.
This position tracks (database entry), updates, reports and communicates NNI publication projects and deliverables with minimal direction. The Manager, Publications leverages his / her technical experience and understanding of the organization and its processes to guide the successful completion of key publications.
Relationships
This position reports to a Director Level Team Member within Scientific Communications (SC), Medical Affairs.
The Manager-Publications is expected to develop and utilize a network of internal relationships with local and global publication stakeholders, including colleagues from Medical Affairs, Clinical Data Science & Evidence, legal, regulatory affairs, global publication team, and commercial publications colleagues from market access and marketing.
The Manager - Publications is also expected to network effectively with external resources (e.g., authors) and work closely with external vendors, stakeholders, and agencies.
Essential Functions
Works with minimal direction; their manager conducts periodic reviews of progress and results
Functions at a proficient levelParticipates in cross-functional project teams locally and / or globallyMay act as a project leader with own manager oversightHas the ability to identify and resolve problems related to publication projects, processes, or tasks, with management support as neededExercises judgment within defined procedures and policiesActs as a key contact point for publication activities for internal and external stakeholders for assigned therapeutic areas / therapiesProvides guidance / conducts training of internal and external stakeholders on publication planning and processesEngages directly with external HCPs / KOLs that are potential authorsApplies their experience to the quality assessment of documentsHas knowledge of external publication and industry guidelines. Educates others as neededRemains current with respect to assigned Novo Nordisk therapeutic areas and competitor productsPublications :Drives the development and update of NNI publication strategies and publication plans for the assigned therapeutic area in alignment with global and NNI medical strategies and publication plans with minimal direction from a Director Level Team Member
Drives the execution and reporting of publication plan activitiesInteracts with local and global publication groups, journals, editors, authors, and others as necessary to ensure the successful completion of publication projectsManages agency partners and other external stakeholders involved in developing and submitting publications to peer-reviewed scientific journals and scientific / medical conferencesWorks closely with agency partners and consultants (as a day-to-day contact) to manage project status, publication drafts, author comments, NNI reviews / approvals, and maintains Datavision publication records and reportingAs needed, prepare and review manuscripts, meeting abstracts, scientific poster presentations, including digital solutions for publication support with support from a Director Level Team MemberMay be responsible for planning author meetingsParticipates as needed in PPG functions, prepares required PPG proposals, follows up on meetings, etc.Contributes to publication communication, e.g., newsletters, announcements, etc.Coordinates, prepares, manages, and tracks author engagements in HCP Rex and DatavisionAdvanced level of system use of publication systems, Datavision, Medical Toolbox, etc. Develop training and guide authors, internal and external stakeholders, and vendors in the correct use of publication systems. Develops / aids in developing guidance documents and process descriptions to improve processes related to publication planning and execution at NNIManages, tracks, and reports publication budget and vendor deliverables for assigned therapeutic areas / therapiesQualifications
An MS, MD, or PhD in a Life Science or a PharmD requiredCMPP preferred but not requiredA minimum of 2 years of relevant experience in pharma or a medical communication agency required with a PhD, MD, or PharmD, and 4 years of relevant experience with an MSDemonstrated experience in the preparation of publicationsBasic disease and therapeutic area knowledge in diabetes, obesity, and rare diseases an added advantageGeneral understanding of regulatory requirements and drug development processesDemonstrated proficiency in the use and understanding of computer software (e.g., word processing, graphics, document management)Excellent project management and organizational skills, including the ability to plan, prioritize, and execute on competing projects and timelinesAbility to multitask and work both independently and within multi-disciplinary teamsStrong interpersonal and written communication skills for effective professional communications, with demonstrated ability to cultivate strong working relationships, both with internal and external stakeholdersJ-18808-Ljbffr
