- Developing and executing the strategy and implementation plan for the global Novo Nordisk community of Medical Writing, Clinical Publishing & Trial Master File Archiving and Clinical Transparency.
- Influencing the output from and hence reputation of the professional discipline of medical writing in Novo Nordisk.
- Support the organization in navigating an environment of tight timelines, high-complexity tasks, unforeseeable problems, re-prioritisations, competition for resources, and potentially conflicting interests between departments and demands from the clinical stage development projects.
- Chair the Global Clinical Reporting management meetings and conduct regular hybrid meetings to secure alignment of resources, priorities and tasks across Novo Nordisk sites and all development projects.
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Corporate Vice President - Søborg, Danmark - Novo Nordisk A/S
Beskrivelse
Are you a seasoned leader with experience from a large, complex, and international pharmaceutical company? Are you recognized for your enterprise mindset and your ability to engage and manage senior stakeholders across the value chain? Then you might be our new Corporate Vice President of Clinical Reporting in our global clinical development organisation (Development). Please note this role is based in Copenhagen (Denmark).
About the department
In Clinical Reporting, we use our scientific expertise to drive clear and impactful communication on the conduct and outcome of clinical trials. We perform medical writing, clinical publishing, clinical transparency, and trial master file archiving for Novo Nordisk. We have process responsibility for protocol writing, investigator brochures, clinical study reports, clinical summaries, patient information/informed consent and trial disclosure activities. We are leading process change and digitalisation efforts, such as structured authoring, to enable accelerated submissions to health authorities so we can bring new therapies to patients faster.
Our organisation includes a high-performing and engaged management team of 10 people and a well-established organisation of more than 250 people in Denmark and India.
The position
As CVP for Clinical Reporting you will report to the Senior Vice President for Regulatory, Quality & Clinical Reporting and be part of the international management team with six peers.
You will be responsible for the strategic and operational leadership of the Clinical Reporting area ensuring that business targets and budget are met according to both long-term and short-term business strategies. This includes maintaining momentum of current initiatives and identifying new initiatives within digitalization and simplification to ease collaboration with regulators, clinical trial investigators and other internal- and external stakeholders.
You will represent Clinical Reporting in Novo Nordisk and set direction for the area and engage with the global community of medical writing, clinical publishing, and clinical transparency groups. This includes:
Part of the complexity for this role can be explained by an increasing number of trials, including therapy areas that are new to Novo Nordisk. This means that the functions' stakeholder landscape has become increasingly complex. The Clinical Reporting organisation is well-established and maintains strong relationships with both internal and external stakeholders, and it is important to keep that momentum and retain the reputation of Novo Nordisk. As a leader, you ensure the organisation delivers high-quality scientific documentation, and that innovations are identified and implemented to continuously improve and simplify processes. In addition, you lead with an enterprise mindset and collaborate with peers to shape the regulatory documentation and promote cross-functional collaborations across Novo Nordisk.
As a leader within Novo Nordisk, you are responsible for leading Clinical Reporting according to the strong and unique company values combining humanity, ambition, and quality known as the Novo Nordisk Way.
Qualifications
You are a seasoned leader with experience operating at Vice President+ level from a similarly complex and international pharmaceutical organisation. You possess knowledge of global regulatory processes and requirements as well as quality requirements such as GxP and ISO, preferably from a comparable role.
You are recognized as an impactful people leader with experience leading organisations of 100 people or more. You are known for your enterprise mindset, and ability to engage and manage stakeholders on all levels from many functions including regulators and clinical trial investigators.
In addition, you have demonstrated you can lead change within digitalization, culture, and optimization of ways of working to increase simplicity.
As a person you have excellent interpersonal and collaboration skills, combined with an ability to make clear decisions. You set direction whilst leading by example and empowering your leaders to build effective teams and promote cross organisational collaboration. You function as a role model by being accountable, ambitious, responsible, engaged with stakeholders, open and honest and ready for change.
You hold a master's degree or PhD within a relevant area.
