Medical and Regulatory Writer I

61 Coordinate overall quality review of documents

61 Perform quality checks for internal consistency of data, compliance with applicable templates and style guides, accuracy and completeness of references, etc.

61 Ensure delivery of requested documents according to timelines within budget and to acceptable quality standards

61 Provide support to other medical and regulatory writers to ensure delivery of documents according to timelines and within budget and to acceptable quality standards

61 Participate in training activities to expand medical and regulatory writing capabilities (e.g. writing expertise, different kinds of documents, understanding clinical and regulatory functions, etc.)

61 Any other activities related to the position as required by direct supervisor

Supervisory Responsibilities:

No supervisory responsibilities.

Job Requirements:

61 Education

o A university degree in the field of science or medicine, graduate/postgraduate degree preferred

61 Experience

o At least 1 year of scientific/technical writing experience, CRO experience a plus

61 Skills/Competencies

o Strong written and verbal communication skills in English

o Strong computer skills, including Microsoft Office

o Proficiency in medical terminology preferred

o Able to exercise judgment within defined procedures and practices and to determine appropriate action independently

o Strong attention to detail

o Strong problem-solving skills

o Able to follow applicable local and national regulatory guidance and document specifications with minimum supervision

61 Capabilities

o Ability to work in a digital environment using computer systems

o Ability to work within a team

o Ability to work on global projects in a multi-cultural environment

o Ability to travel, if needed