Senior Publications Manager

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The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From healthcare 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?

The Senior Manager, Publications is responsible for the efficient, compliant and timely execution of approved NNI publication plans across assigned therapies and therapeutic areas, with direction from the Associate Director or Director.

The role translates approved plan priorities into defined projects and deliverables; coordinates authors, agencies and cross-functional reviewers; maintains accurate systems and records; tracks timelines, budgets, risks and metrics; and communicates status and recommended actions. The Senior Manager applies technical publication expertise and organizational knowledge to complete assigned work with increasing independence and timely escalation.

This position reports to an Associate Director or Director within Scientific Publications & Information, Scientific Communications, Medical Affairs. The Senior Manager develops and uses a network of local and global publication stakeholders, including colleagues from Medical Affairs, Clinical Data Science & Evidence, Clinical Development, Biostatistics, HEOR/RWE, Legal/Compliance, Regulatory, Market Access and Marketing, to execute assigned publication projects.

The Senior Manager builds effective, compliant working relationships with authors and works closely with external vendors, journal and congress contacts, stakeholders and agencies on assigned deliverables.

• General:
  • Executes assigned work with general direction; agrees priorities and decision boundaries with the manager and provides timely updates, options and escalations through periodic reviews of progress, risks and results.
  • Independently executes moderately complex publication projects and applies proficient technical and operational judgment within approved plans and processes.
  • Participates in local and/or global cross-functional teams and coordinates work streams required to deliver assigned publication projects.
  • Acts as project lead for assigned publication deliverables with Associate Director or Director oversight.
  • Identifies and resolves routine publication project, process and vendor issues and escalates decisions involving strategy, compliance, resources, budget or material delivery risk.
  • Exercises judgment within approved publication plans, procedures, policies and decision rights.
  • Acts as a key contact point for publication activities for internal and external stakeholders for assigned therapeutic areas/therapies.
  • Provides process guidance and training to internal and external stakeholders on approved publication workflows, systems and requirements.
  • Engages directly with external HCPs/KOLs that are potential authors.
  • Applies their experience to the quality assessment of documents.
  • Applies working knowledge of GPP 2022, ICMJE, external publication guidelines, company SOPs and applicable compliance requirements to assigned work.
  • Remains current with respect to assigned Novo Nordisk therapeutic areas and competitor products.
• Publications:
  • Contributes data, landscape insights, feasibility assessments and execution recommendations to the development and update of publication plans; executes the approved strategy and priorities for assigned therapeutic areas and assets.
  • Manages day-to-day execution and reporting of assigned publication plan activities, including schedules, dependencies, reviews, approvals, submissions, records, metrics and follow-up actions.
  • Coordinates with local and global publication groups, journals, editors, congresses, authors and reviewers to complete assigned publication projects successfully and compliantly.
  • Manages agency partners and external stakeholders responsible for developing and submitting assigned publications, monitoring quality, timelines, scope, budget and issue…