Medical Writing Manager

Work Schedule

Environmental Conditions

Job Description

Summarized Purpose:

Effectively manages staff and related projects to deliver quality products in agreed timelines. Supports operational excellence and initiates improvements within the department. Mentors and develops staff encouraging their professional skills. Collaborates internally and with external clients. Works to resolve complex problems that meet client deliverables and needs. Essential Functions and Other Job Information:

Essential Functions

• Manages staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations. Approves courses of action on salary administration, hiring, corrective action, and terminations. Reviews and approves time records, expense reports, requests for leave, and overtime (if applicable).
• Directs the daily operations of the team. Fields questions from the team as well as other departments and works to resolve complex problems ensuring the review of multiple complex deliverables are organized and timely. Leads and/or contributes to team meetings.
• Serves as lead reviewer on large review projects. Collaborates with internal and external clients ensuring deliverables are met. Manages projects to deliver quality products in agreed upon timelines. Maintains knowledge and communicates current and updated guidelines and regulations to staff regarding clinical trials and document and/or other submission specifications.
• Supports operational excellence by monitoring performance metrics to ensure a efficient processes. Initiates process improvements within the department by influencing processes and technology that drive the reviews. Participates and contributes to meetings and activities.
• Assists in the development, documentation and maintenance of business processes for document review through SOPs, WPDs and guides. Policy & Strategy Interprets and administers policies, processes, and procedures that may affect sections and subordinate work units. 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 adequacy in meeting objectives. A portion of the time may be spent performing individual tasks. Liaison Interacts frequently with internal personnel and outside representatives at various levels. Participates and presents at meetings with internal and external representatives. Interaction typically concerns resolution of operational and scheduling issues.
• Qualifications: Education and Experience:
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 7+ years). 1+ year of leadership responsibility In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities:
• Ability to delegate tasks and facilitate completion of assignments
• Effective management skills, including the ability to create and modify budgets, project timelines, allocate resources, and forecast departmental workload
• Demonstrated innovation in developing new ideas related to process improvements
• Strong document and quality review knowledge
• Proficient in Microsoft (MS) Word and MS Excel
• Advanced organizational, analytical and interpersonal skills to manage several complex projects in parallel and manage rapidly changing priorities
• Ability to independently assess client needs and work with project team members in producing compliant deliverables
• Ability to independently learn new technologies
• Advanced editorial/proofreading skills
• Strong leadership to a diverse staff
• Ability to work on extremely complex problems where analysis of situations or data requires an evaluation of intangible variables
• Ability to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results
• Capable of dealing with pressure and remaining motivated
• Capable of working independently and collaboratively with a team in a cross-cultural, geographically dispersed environment Management Role: Manages experienced professionals and / or subordinate management who exercise latitude and independence in their assignments. Often heads one or more sections or a small department. Working Conditions and Environment:
• Work is performed in an office and/or a clinical environment with exposure to electrical office equipment.