Facilitate integration of US-based individuals within portfolio group and integration of US-specific regulatory aspects into projects in general within the portfolio.
Facilitate integration of US-based individuals within portfolio group and integration of US-specific regulatory aspects into projects in general within the portfolio.
Input to Medicine Development Strategy and Commercialization strategy in order to optimise the Target Product Profile and label and ensure alignment with business objectives.
Support for internal audits, external global audits, regulatory agency audits and system compliance risk assessments as subject matter expert in assigned validation discipline.
Supports regulatory affairs teams for all new registrations and supplements to assigned projects and products including preparation of responses to Health Authority questions.
Provide robust regulatory advice and plans to the various project teams and advisory bodies to ensure that the business needs are in compliance with regulations and/or regulatory advice received from the agencies.
Assist with the development and implementation of forward thinking EHS improvement programs to deliver year on year reductions in both workplace injuries and illnesses.
Develop a strong internal and external partnerships to acquire data assets to drive US pharma business strategy and maximize the return on investments in the data assets.
Work closely with key external experts to enable the translational medicine pathWork closely with other NS Leadership team members to execute and evolve the NS strategy.
Developing and implementing appropriate methods for analysis and visualisation of data from wearable/digital devices, and identifying suitable clinical endpoints based on these data .
Manage staff of direct and indirect reports to support their career development and compliance with organizational and regulatory policies and standards.
Serves as the in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific activities with internal stakeholders as they relate to ongoing projects.
Serves as the in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific activities with internal stakeholders as they relate to ongoing projects.
Develops novel regulatory strategies and influences approaches, in order to secure competitive approvals and speed to market in conjunction with LOC regulatory teams.
The Principal Scientific Writer has knowledge of team management (roles and responsibilities) and acts as a representative or spokesperson for the Scientific Writing and/or multifunctional team to complete specific tasks.
