Work Schedule
Environmental Conditions
Job Description
Summarized Purpose:
Effectively manages medical writing projects and regional operations ensuring high-quality and timely delivery of medical/scientific writing products to internal and external clients. Provides substantive advice on strategy, regulations and industry best practices demonstrating subject matter and therapeutic area expertise. Manages the business development and pricing functions of projects for clients or alliance partners and contributes substantially to business development. Develops, mentors and guides medical writing staff.
Essential Functions and Other Job Information:
Education and Experience: Bachelor’s degree in a science-related field required; Advanced degree (PharmD, PhD, Masters) preferred Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years) or equivalent and relevant combination of education, training, & experience. 2+ years of management responsibility 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:
Broad range of medical writing project experience and knowledge of global regulatory requirements for clinical trials, marketing authorization and late phase procedures and in-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory, submissions.
Excellent interpersonal skills including problem solving, judgment, and decision-making skills
Ability to manage people including performance management, training, mentoring, directing and supervising work, and motivating employees
Strong project management skills, including the ability to plan and manage projects, create and modify project budgets, develop timelines, allocate resources, and forecast departmental workload
Strong communication, negotiation, and presentation skills needed to represent the department in a range of situations including bid defenses, capabilities presentations, and audits
In depth knowledge of departmental processes; ability to identify emerging needs and propose/develop/ implement new or improved processes
Excellent medical writing skills, including grammatical, editorial, and proofreading skills, and the ability to interpret and present complex data Management Role:
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