Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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:
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- Manages medical writers including management of workload, allocation of staff to projects, recruitment, development, training, performance, and personnel issues for managers and writers
- Identifies needs and promotes development of new departmental processes and standards. May lead departmental teams for process improvement and participates in cross-functional process development
- May be the functional MW lead for a project and provide support for writing routine or complex documents.
- Provides advice and guidance to writers on technical and regulatory aspects of document preparation.
- Provides senior review of documents. Serves as first line of escalation for project risks.
- Develops and approves project budgets and advises direct reports on contract and budget issues for large complex projects
- Manages the business development and pricing of projects for one or more clients or alliance partners and participates in contract negotiations. Assists business development and senior management in securing new business by making presentations to clients.
- Participates in developing and reviewing proposal texts and budgets in collaboration with Proposal & Contracts Development. Assists with development of contract modifications and liaises with C&PD to follow through on all aspects of contract modification.
- Attends relevant FDA, industry and scientific meetings and maintain relationships with industry contacts. Provides support to direct reports for complex client management issues Policy & Strategy Interprets and administers policies, processes, and procedures that may affect sections and subordinate work units.
- Acts as advisor to subordinate(s) to meet schedules and / or resolve technical problems. Requires full knowledge of own area of functional responsibility.
- Freedom to Act Assignments are defined in terms of activities and objectives. Work is reviewed upon completion for meeting timelines, adequacy, and objectives. Liaison Interacts frequently with internal personnel and outside representatives at various levels.
- Participates and may present at meetings with internal and external representatives. Interaction typically concerns resolution of operational and scheduling issues concerning projects and / or contractual clarifications. Qualifications:
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: