Job Description
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global 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 proofreading skills, and the ability to interpret and present complex data
Ability to effectively communicate, negotiate, engage and support potential clients, corporate leaders and across functional area strong presentation skills
Excellent interpersonal skills including problem solving, judgment, and decision-making skills; self motivated and adaptable
In-depth knowledge in a specialty area; preclinical, therapeutic, regulatory, submissions, communication, etc.
Management Role
Directs through lower management levels. Has responsibility for managing a function that includes multiple related departments. In some instances, may be responsible for a functional area (as determined by executive management) and not have subordinate supervisors or employees. May manage employees across multiple regions.
What we offer
At the clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at the clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees.
We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.
Our 4i Values:
Integrity - Innovation - Intensity - Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application - we’d love to hear from you!
