Regulatory Writing Excellence
• Produce, and co-ordinate production of, a wide range of regulatory documentation in accordance with the needs of the client and of regulatory authorities.
• Manage multiple projects, taking overall responsibility for successful delivery and instilling accountability in others.
• Rapidly assimilate clinical development data and objectively evaluate source information; grasp key issues for regulatory documents and understand their context.
• Demonstrate an excellent understanding of the needs of regulatory authorities and use this to provide advice internally and to clients. Keep abreast of developments and requirements of regulatory authorities for relevant documentation.
• Pick up and assess complex, non-standard, or new project types and progress these efficiently and appropriately; quickly get up to speed with new therapy areas and processes.
• Act as a key source of expertise for projects, including advising internally on client’s standard operating procedures and processes and liaise with client to provide feedback and suggested improvements.
• Enable team to produce documentation that meets client and regulatory requirements and is appropriate, in terms of readability, accuracy and ‘fit for purpose’.
• Manage workload effectively, and prioritize/reprioritize effectively, to meet deadlines for fast-paced and multiple parallel projects. Support less experienced team members in task prioritization.
• Participate in formal and on-the-job training, complete assigned training to the required standard and within the given timeframes. Provide feedback on training to support program development.
Internal Leadership / Development of Others
• Liaise with resourcing lead to manage assignment of resource and to contribute to resource forecasting, as required. Identify elements of projects that can be supported by other writers and freelancers, including opportunities for training.
• Lead, coach and motivate project teams, providing support and guidance to team members on client and project issues, leading troubleshooting discussions regarding project delivery and establishing clear guidelines and ways of working for more complex projects to ensure consistency and efficiency.
• Use proven track record to coach, mentor, brief, and review work for writers of all levels.
• Enable team to produce documentation that meets client and regulatory requirements and is appropriate, in terms of readability, accuracy and ‘fit for purpose’.
• Provide strategic leadership in leading multi-document projects and co-ordinating the work of other team members.
• Develop close working relationships with team members thereby enabling provision of regular feedback on performance, both directly and to line managers.
• Actively participate in the effective and efficient implementation of Complete Regulatory training and development, coaching individual team members and leading workshops, where required.
• Proactively share extensive knowledge and experience with team members, working collaboratively to help meet team objectives.
• Work closely with senior colleagues to ensure that a client-focused and high-performance culture is maintained within Complete Regulatory.
• Use experience and knowledge to contribute to Complete Regulatory Process improvement.
• Liaise effectively with the client, acting as the primary point of contact overseeing a group of projects or submission; effectively anticipating or troubleshooting any objections from clients to ensure continuing good relationships.
• Build positive relationships with clients by being a knowledgeable point of contact and providing strategic advice; contribute to discussions to identify issues and recommend solutions.
• Confidently lead any type of meeting and offer strategic advice to clients; contribute to complex or sensitive client meetings.
• Demonstrate robust commercial/financial awareness and awareness of budget and scope for each project and communicate this with team members; work with senior team members to identify issues and support good recoverability.
• Meet individual chargeability levels and support other team members to meet chargeability levels.
• Maintain and secure profitable ongoing business and expand opportunities on projects.
• Participate in business development by assisting in developing relationships with new clients.
• Contribute to, and participate in, new proposal development and pitches where appropriate.
• Collaborate with other agencies where appropriate.