Senior Medical 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. Demonstrates subject matter and therapeutic area expertise. May assist program manager. Collaborates with internal and external clients supporting and enabling effective and efficient communication that results in operational excellence.

• Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols and summarizes data fromclinical studies.
• May research write or edit complex clinical and scientific and program level documents including IBs INDs and MAAs.
• Reviews routine documents prepared by junior team members. May provide training and mentorship for junior 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. Provides input on and independently develops best practices methods and techniques for achieving optimal results including various client specific processes.
• May assist in program management activities. Identifies and resolves out-of scope activities. Duties could include developing timelines budgets forecastsand contract modifications.
• 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 5 years).

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 :

Excellent data interpretation and medical writing skills including grammatical editorial and proofreading skills

Strong project management skills

Excellent interpersonal skills including problem solving

Strong negotiation skills

Excellent oral and written communication skills with strong presentation skills

Significant knowledge of global regional national and other document development guidelines

In-depth knowledge in a specialty area such as preclinical therapeutic regulatory submissions communications etc.

Great judgment and decision-making skills

Excellent computer skills and skilled with client templates;

Good knowledge of document management systems and other relevant applications (e.g. Excel Outlook)

Required Experience :

Senior IC

Key Skills

Clinical Research,Adobe Acrobat,FDA Regulations,Technical Writing,Biotechnology,Clinical Development,Clinical Trials,Microsoft Powerpoint,Research Experience,Document Management Systems,Word Processing,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1