Associate Director, Scientific & Medical Writing Services

The primary role of the Associate Director is to ensure the satisfactory management of medical writing operations in a manner consistent with Corporate and Department mission and goals. Must have FDA Independent Review Charter writing experience and an understanding of imaging criteria within clinical trials. Responsibilities include serving as internal and external representative for medical writing, coordination with other departmental management to harmonize processes, employee development, and management of team; supervision and management of medical writing staff; review of department budget; seeking and following up on medical writing sales opportunities, and leading departmental and cross-functional communications, training, and process improvements. The Associate Director will also have responsibilities as a client liaison or partnership lead and will support medical writing management during the sales process by providing sales input.

Key Accountabilities:

Medical Writing Team Oversight - team of 5 - 6Facilitate harmonization of medical writing management.Oversee maintenance of medical writing-related standard operating procedures and guidelines with continual evaluation of systems for improvement.Lead development, and continuous improvement of medical writing training, and career development initiatives.Identify and resolve inter-departmental challenges and issues in a team-oriented environment through cooperative initiatives with other department headsServe as Chairperson for regular medical writing staff meetings, intra- and inter-departmental information sharing venues, as appropriate.Review current progress/progress forecasts and medical writing department performance against defined metrics.Employ change management be identifying key drivers which will help manage change within and across the region/department, so that all employees are committed to modifications.Supervise and mentor medical writing staff and line managers, including all aspects of medical writing personnel management: job description development and maintenance, hiring, training, professional development, periodic/annual performance evaluations, compensation recommendations, promotions, and supervision of adherence to departmental procedures and health authority guidance and regulationsUndertake the full range of duties relevant to the leadership, management, and development of line reports to ensure their performance meets and or exceeds both the business and their own personal goals/objectives.Provide strategic/technical input to project administration of medical writing projects, from contract development through to closureOversee efficient budgeting and support financial monitoring to maximize profitability of assigned projects.Manage assigned customer accounts to ensure their needs are being met to a high degree of service, developing relationships within accounts, and identifying and pursuing new business opportunities with accounts under area of responsibility.In the proposal generation process, provide strategic and project planning intelligence for medical writing activities.Participate as member or leader of departmental committees (e.g., process improvement, standards, partnerships).

Skills:Excellent interpersonal, negotiation, verbal, and written communication skillsSeveral years of management experienceAbility to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills.Competent working in a matrix environment and values the importance of team work.Possesses team leadership skills, cross-cultural sensitivity, and can influence without authority.As client liaison, demonstrates a client-focused approach to work and establishes a connection with the client, to gain repeat business and/or to widen existing scope and services.Provides departmental expertise and perspectives to promote prospective business opportunitiesQualificationsKnowledge and Experience:

Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations.Broad experience in management of complex medical writing projects.Significant previous line management experience, preferably in a billable service industry.Project management experience (e.g., planning and monitoring).Business awareness/business development experience.Advanced word processing skills, including MS office (expertise in Word and competency in Excel); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases.Ability to travel.Fluent in written and spoken English.Education:Bachelors DegreeEEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.