Job Description

Work Schedule OtherEnvironmental Conditions OfficePosition Overview:Provides high-quality regulatory medical writing for internal and external clients. Provides technical consultation and substantive advice on strategy, regulations, and industry best practices. Demonstrates subject matter and therapeutic area expertise. Effectively manages medical writing projects to deliver quality products in agreed timelines. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.Essential Duties and Responsibilities (other duties may be assigned):

• Independently researches, writes, and edits peri-/post-approval clinical study reports, study protocols, informed consent forms, and other peri-/post-approval regulatory documents. May support complex clinical or scientific documents, such as, IBs, and sections of INDs, NDAs, and CTDs.
• Manages all aspects of planning, organizing, and executing projects without supervision including: developing project timelines, standards, budgets, forecasts, and contract modifications. Liaises with other functional units as necessary (i.e., project management, clinical, QA, data management, biostatistics, regulatory, and other Evidera practice areas). Identifies and escalates out-of-scope project activities in a timely manner and proposes solutions.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Interacts with internal and external personnel on significant matters often requiring coordination between functional areas. Networks with senior internal and external personnel in own area of expertise.
• Normally receives little instruction on day-to-day work, general instructions on new assignments. Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Represents the department as a primary contact on projects including project launch meetings, review meetings, client audits, bid defenses, and capabilities presentations. Establishes and develops client relationships; independently initiates and leads interactions with clients. Assists with business development and development of budgets and proposals.

Education, Professional Skills & Experience:

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic/vocational qualification; Advanced degree preferred.
• Previous experience as a writer that provides the knowledge, skills, and abilities to perform the job (comparable to 2-5 years) or equivalent combination of education, training, & experience.
• Experience working in the pharmaceutical/CRO industry is preferred.
• Additional qualifications in medical writing (AMWA; EMWA; BELS; RAC) are advantageous.
• Significant knowledge of global, regional, national, and other document development guidelines.
• In-depth knowledge in a specialty area such as therapeutic, regulatory submissions, healthcare communications, etc.
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook).

Personal Skills & Competencies:

• Excellent written English: demonstrated ability to communicate and document information effectively in written English, including the ability to produce documents, emails, and other written pieces that are well-organized, free from errors, and appropriately adjusted to the characteristics and needs of the audience
• Aptitude to accurately work with, manipulate, and format numbers, numerical information, and data of various types to provide evidence, information, and insights
• Able to analyze complex issues and evidence, identify information gaps, identify cause-effect relationships, and generate effective solutions.
• Able to create, communicate, and manage effective project plans that support the delivery of overall project objective(s); identify, manage, and guide project team members; to monitor and report on progress in an organized fashion; and deliver the required results.
• Demonstrates sound professional judgment in analyzing, responding to, and resolving enquiries, issues and escalations.
• Able to facilitate the resolution of conflict among team members and clients, through listening and understanding the cause(s), gaining agreement on an appropriate course of action, and following up to ensure a successful outcome.

Thermo Fisher Scientific