At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a general scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Our colleagues in quality strive for excellence in every task, at every moment. We are game changers seeking improvements to processes and more efficient ways of working or adapting to changing financial and industry environments.
**Director Medical Writing - Early Development**
Provides regional strategic direction and oversight to one or more Medical Writing groups to deliver quality products in agreed timelines. Develops the departmental organizational structure, recruits, trains and motivates staff to ensure performance excellence. Develops and manages the operating budgets and identifies new business opportunities & Medical Writing projects. Leads the implementation of changes in departmental remit, process, and operations to regionally align Medical Writing with the strategic direction and goals of the organization.
**Essential Functions**
- Provides oversight to one or more Medical Writing groups, developing and communicating the strategic direction for the groups. Recruits, engages, manages and motivates staff to ensure excellence in performance. Develops an organizational structure and communicates departmental goals and priorities. Leads the implementation of changes in departmental remit, processes, and operations to develop the group in line with the strategic direction and goals of the organization.
- Provides significant input into the development and management of the departmental budget. Promotes and advocates for the business needs of the Medical Writing group. Builds relationships with other PPD departments and seeks opportunities to collaborate with other functions for mutual benefit (e.g. Phase I medical writing, PK, biostatistics, PVG, regulatory). Anticipates the need for change and actively supports a changing environment. Provides creative, novel ideas for taking the organization forward.
- Identifies and develops business opportunities involving new Medical Writing projects and opportunities for the company. Takes a leading role in working with business development and senior management in securing new business by making presentations to clients, conducting contract negotiations, developing and reviewing proposal texts and budgets, in collaboration with Proposal & Contracts Development.
- Resolves or escalates serious project issues and risks to senior management. Prepares reports regarding significant project issues to senior management as needed. Provides leadership in handling complex client management issues. Assumes primary responsibility for the visibility and reputation of the Medical Writing group within PPD.
**Education and Experience**
- Minimum 7+ years' experience that provides the knowledge, skills, and abilities to perform the job or equivalent and relevant combination of education, training, & experience.
- Management experience necessary.
- Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions._
**Knowledge, Skills and Abilities**
- Strong leadership skills with the ability to manage people including performance, training, mentoring, directing and motivating staff
- Extensive business knowledge with comprehensive understanding of the organization and functional areas
- Excellent project management skills, including the ability to organize, plan and manage projects, create and modify budgets, develop timelines, allocate resources, and forecast departmental workload
- Excellent knowledge of global/regional medical writing/regulatory requirements for clinical trials, marketing authorization and late phase procedures; experience across the product development lifecyle
- Ability to contribute to and drive strategic planning on behalf of the organization and department, including effective communication, logic and influence
- Innovation and leadership in developing new ideas related to Medical Writing, including process improvements
- Excellent medical writing skills, including grammatical, editorial, and proofr