Principal Med Writer

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 documentpreparation 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 practicesmethods 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 andcontract modifications and assisting business development with client presentations and proposal text review and attending bid defense meetings andcapabilities presentations.

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

Qualifications :

Education and Experience :

Bachelors 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

Required Experience :

Staff IC

Key Skills

Photography,Proofreading,Fact check,Interviewing,AP Style,Journalism,SEO,Copywriting,Creative Writing,Wordpress,Blogging,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1