Novo Nordisk

Compliance

• Take ownership of regulatory strategies and submissions across global markets
• Lead submission planning by applying regulatory intelligence and developing robust regulatory strategies
• Prepare, submit, and maintain regulatory files including MAA/NDA/BLA, CTA/IND
• Respond to questions from health authorities and maintain marketing authorisations globally
• Manage interactions with affiliates to ensure aligned and timely execution
• Plan and conduct regulatory interactions with health authorities
• Represent the Regulatory Affairs function in the RA matrix team
• Drive effective information flow to the matrix team to support decision-making
• Be accountable for the overall RA CMC/Device regulatory strategy
• Align with Product Supply, affiliates, and GRL for timely progress of activities
• Inform Line of Business about business-critical decisions

Senior Regulatory Professional/Associate Specialist

Project Manager

• Act as Work Package Owner for the QC Laboratory, representing Novo Nordisk towards local CMO(s)
• Coordinate QC Laboratory technology transfer and analytical method transfer activities
• Maintain solid oversight of the method transfer process
• Support QC Laboratory design, setup, qualification and validation readiness
• Provide guidance, training and mentoring to local partner(s) in line with Novo Nordisk standards
• Safeguard compliance with EU GMP, FDA and Novo Nordisk Quality requirements
• Manage milestones, risks and interfaces with other work packages

Project Manager – QC Laboratory

Data Management

• Planning, coordinating, and delivering data management activities across one or more clinical trials.
• Ensuring data quality, integrity, and timely delivery of clinical trial data throughout the study lifecycle.
• Acting as the Data Management lead for assigned trials.
• Collaborating with colleagues, vendors, and global stakeholders.
• Defining and overseeing data collection strategies, standards, and quality plans.
• Managing risks, issues, and dependencies related to trial data.
• Contributing to continuous improvement initiatives and the implementation of innovative ways of working.
• Supporting inspection and audit readiness activities.

Senior Clinical Data Management Professional

Manager

• Supervising day-to-day usage, processes, operation and maintenance of OSB and CDW
• Managing vendor relationships including developing and negotiating SLAs
• Driving incident and problem management in collaboration with vendors and architects
• Ensuring systems remain compliant with quality management procedures and regulatory guidelines
• Actively participating in Agile meetings to define system strategy
• Creating and evaluating funding models to ensure sufficient support levels
• Championing continuous improvement of processes surrounding the systems.

Associate Lead System Manager

Account Executive

• Promote Novo Nordisk's portfolio to General Practitioners and Pharmacists across Geelong, Bellarine Peninsula, and Ballarat
• Engage with existing General Practitioners and expand the target group of customers
• Build patient-centric HCP relationships through a highly organised approach
• Develop and execute a robust territory business plan
• Execute marketing strategies and conduct group presentations
• Ensure compliance with business ethics procedures and local laws

GP Sales Representative

• Take ownership of complex regulatory processes that directly enable Novo Nordisk's medicines to reach patients worldwide.
• Navigate diverse regulatory landscapes and drive submissions across major markets.
• Regulatory submissions to health authorities worldwide.
• Lead submission planning by applying regulatory intelligence and developing robust regulatory strategies across global markets.
• Prepare, maintain and submit regulatory files including MAA/NDA/BLA, NBOp, CE, CTA/IND, device files, site master files, renewals, post-approval changes and commitments.
• Respond to questions from health authorities and manage ongoing interactions with affiliates to ensure alignment and compliance.
• Plan and conduct regulatory interactions with health authorities, including preparation of meeting requests, meeting packages, rehearsals and formal meeting minutes.
• Provide strategic input to affiliates in preparation for health authority interactions.
• Represent the Regulatory Affairs function in RA matrix teams, ensuring alignment of planning and strategy across areas.
• Drive innovation and optimisation projects within the regulatory space.

CMC Regulatory Specialist

Data Scientist

• Set direction for Data science toolbox, data architecture and workflows development
• Responsible for business request analyze, common data models development and data relocatable data services development
• Continuously research and evaluate new AI/ML tools and technologies

Senior Data Scientist

Affiliate Manager

• Support the implementation and application of NNPILP training programs and standards by assisting with the design, delivery, and evaluation of training content across functional areas.
• Help maintain and improve local training efforts to ensure consistency with established standards and contribute to operational effectiveness.
• Provide support to the identification, structure, and assignment of just-in-time training.
• Support the execution of training initiatives.
• Set priorities based on training needs, ensuring training milestones are met by reviewing records and identifying gaps.
• Lead or participate in training development workshops, aligning with business lines to resolve key issues effectively.
• Provide guidance on Global and NNPILP training standards, enhancing communication with the line of business.
• Foster a network of local training supporters to promote knowledge sharing and improve the training system.
• Assist in training and coaching trainers to ensure they provide effective support for their departments while sustaining a strong training system.
• Apply training principles to evaluate effectiveness, conduct needs analyses, and assess suitable training methods.
• Support continuous improvement in training activities and methods while participating in internal audits when necessary.
• Facilitate courses on operational training tools and perform assessments on training system utilization.
• Follow all safety & environmental requirements in the performance of duties.

Training Partner I

Medical Director

• Within Field Medical Affairs (FMA), has primary responsibility for directing clinical engagement efforts and developing/implementing medical account strategies on behalf of NNI among identified strategic and priority Managed Markets accounts
• Provides evidence-based scientific information for NNI products to executive decision makers, thought leaders, and business influencers
• Responsible for managing multiple internal relationships (mainly Market Access, Medical Operations, HEOR, and Medical Affairs)
• Acts as a scientific resource for health care providers (HCPs) and other NNI employees as required
• Attends and presents at assigned medical and scientific meetings
• Works collaboratively with the Senior Management of Managed Markets, HEOR, and Medical Affairs to identify, manage, and coordinate medical support needs at key MM accounts

Medical Account Director – National Account

• Contributing to the late-stage development strategy for one of Novo Nordisk's key assets within the obesity and cardiometabolic health therapy area
• Developing and planning the global marketing authorisation submission strategy for a highly complex development programme pursuing multiple indications
• Driving innovative and fit-for-purpose submission strategies, including exploring new ways of structuring and executing submissions to support complexity, speed, and quality
• Leading and guiding the regulatory submission team and cross-functional stakeholders to ensure aligned execution, strong decision-making, and timely delivery of submission activities
• Working across development projects in combination with life cycle management activities, ensuring a coherent and forward-looking regulatory strategy

Regulatory Affairs Specialist

Technician

• Drive microbial and recovery process development in our technical pilot facility
• Plan and execute recovery campaigns for tox material and process development work
• Operate and maintain pilot-scale chromatography equipment and associated systems
• Perform sampling, buffer preparation, and experiment setup with precision and care
• Contribute to the daily operation and continuous improvement of the facility
• Document work in electronic systems according to quality standards
• Collaborate closely with scientists and fellow technicians to drive experimental success
• Potential member of on-call team for facility utilities in Bagsværd site

Director

• Lead the strategic governance and continuous improvement of the global pharmacovigilance system framework
• Oversee the governance of pharmacovigilance regulatory intelligence, process management, organizational training, and change implementation
• Chair or facilitate regulatory intelligence governance board
• Provide strategic recommendations to the EU QPPV and senior leadership regarding implementation priorities and compliance risks
• Drive the design, implementation, review, and optimisation of pharmacovigilance processes, standards, procedures, and ways of working
• Develop and oversee the global pharmacovigilance training governance framework
• Lead and develop a team of Process Excellence professionals

Director of Pharmacovigilance Process Excellence

Data Analyst

• Managing site and user access across clinical data management systems such as EDC and eCOA platforms.
• Creating, maintaining, and deactivating user accounts for internal and external stakeholders.
• Performing configuration activities within user management tools and Veeva systems.
• Managing rights, roles, study setup activities, and study closure/decommissioning processes.
• Supporting incident management and resolving user access and system-related queries.
• Ensuring documentation is maintained in accordance with company standards, SOPs, GCP, GDP, and GxP requirements.
• Collaborating with cross-functional and global teams to meet project timelines and operational goals.
• Contributing to process improvements and sharing best practices across teams and functions.

Senior Associate Clinical Data Insights Analyst

Financial Planning and Analysis

• Supporting monthly closing activities and ensuring accurate and timely financial reporting in alignment with global standards
• Collaborating with global finance teams and the shared service center in India on day-to-day accounting processes
• Assisting with annual budget planning, forecasting and variance analysis
• Processing and reviewing transactions across a broad range of accounting areas including accounts payable, fixed assets and cost accounting
• Contributing to continuous improvement of finance processes and internal controls
• Supporting ad-hoc financial analysis and reporting requests from local and global stakeholders

Finance Services Supporter

Engineer

• Support compliance with environmental regulations & materials waste handling procedures & regulations, as well as supporting sustainability objectives
• Provide engineering support and input to site strategy ensuring sustainability objectives are met.
• Continuously improve the sites environmental and sustainability processes using cLean methodology.
• Support stakeholders in relation to the site ISO14001 program and prepare site for ISO50001 and ISO46001 certification
• Responsible for waste management procedures content to ensure compliance with current regulatory & security requirements
• Maintain knowledge in energy, waste, and water management and act as SME for investment project teams
• Partner with internal and external stakeholders to forecast consumption and cost for: waste, water, and energy
• Create purchase orders and approve invoices for: waste, water, and energy
• Support the development of Key Performance Indicators (KPIs) related to the company’s strategic goals
• Support development of business cases, based on KPI trends, to implement projects that align with the site’s strategic sustainability goals, to include supporting junior team members
• Support moderately complex projects that align with the site’s strategic sustainability goals
• Remain current with professional organizations and their guidance’s/industry standards (ASHRAE, AEE, AAEES, ISWA, SWANA, ISPE, etc.)
• Support site sustainability standards
• Support complex cross-functional investigations, related to sustainability, & coach other departments on sustainability
• Support global initiatives, including Circular for Zero
• Understand cGMP, FDA, and OSHA regulations
• Follow all safety & environmental requirements in the performance of duties