Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Purpose:

Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. As the lead writer, reviews documents for the team and provides training and guidance to junior team members. Provides advice on document development strategy, regulations and industry best practices. Demonstrates subject matter and therapeutic area expertise. Acts as backup program manager. Collaborates with nternal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

Essential Functions:

• Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies.

• May serve as primary author who writes and provides input on complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.

• Provides senior level review of routine and complex documents. Provides training and mentorship for other writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.

• Ensures compliance with quality processes and requirements for assigned documents. As the subject matter expert, develops and reviews best practices, methods and techniques for achieving optimal results, including various client specific processes, and leads process improvement initiatives. May also develop, review and manage performance metrics for assigned projects.

• May serve as backup program manager. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications, and assisting business development with client presentations and proposal text review, and attending bid defense meetings and capabilities presentations.

• Represents the department at project launch meetings, review meetings, and project team meetings.

Qualifications:

Education and Experience:

Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification;

Advanced degree preferred Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).

Experience in managing and directing complex medical writing projects required Experience working in the pharmaceutical/CRO industry preferred

Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous 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:

• Significant knowledge of global, regional, national and other document development guidelines

• In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc

. • Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills

• Excellent project management skills

• Advanced interpersonal, oral and written communication, and presentation skills • Excellent negotiation skills

• Excellent judgment; high degree of independence in decision making and problem solving

• Ability to mentor and lead junior level staff