Evidera, PPD's peri- and post-approval business, is seeking a talented and experienced Director of Medical Writing.
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.
Principal Duties and Responsibilities:
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 Evidera departments and seeks opportunities to collaborate with other functions within PPD 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.
Establishes policies appropriate for the function. Interprets and recommends modifications to company-wide policies and practices. Develops and is responsible for budgets, schedules, and performance standards.
Objectives are defined in collaboration with senior management and results assessed from a relatively long-term perspective. Interacts with senior management, and others concerning matters of significance to the company. Conducts business and technical briefings for senior and top management and for external management and / or representatives.
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 Evidera and PPD.
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.
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.
Education, Professional Skills & Experience:
Previous experience that provides the knowledge, skills, and abilities to perform the job or equivalent and relevant combination of education, training & experience.
Extensive business knowledge with comprehensive understanding of the organization and functional areas.
Excellent knowledge of global/regional medical writing/regulatory requirements for clinical trials, marketing authorization and late phase procedures; experience across the product development lifecycle.
Ability to contribute to and drive strategic planning on behalf of the organization and department, including effective communication, logic and influence.
In-depth knowledge in a specialty area; preclinical, therapeutic, regulatory, submissions, communication, etc.
Personal Skills & Competencies:
Strong leadership skills with the ability to manage people including performance, training, mentoring, directing and motivating staff.
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.
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.