Medical Writer

The Medical Writer is responsible for authoring clinical trial and regulatory documents, through independent assignment and oversight as well as engagement within a cross-functional team dynamic. This role requires strategic thinking with exceptional scientific and technical writing skills, excellent communication skills and attention to detail, and the ability to manage and prioritize project load independently.

Essential Duties and Responsibilities

• Perform all document authoring steps as outlined by document type and template:
• Author clinical trial and regulatory documents.
• Coordinate quality control of clinical trial and regulatory documents.
• Engage with cross-functional team, as needed.
• Develop accurate, clear and compliant documents as per the project and regulatory requirements.

Education and Experience

• Master’s Degree or above and at least 5 years’ experience in medical writing in the Biotech/Pharmaceutical industryOR Bachelor’s degree and at least 8 years’ experience in medical writing in the Biotech/Pharmaceutical industry.
• Experience understanding and interpreting data/information and its practical application.

Skills and Ability

• Excellent written/oral communication skills and attention to detail.
• Advanced knowledge of scientific/technical writing and editing.
• Strong time and project management skills.
• Strong leadership experience in a team environment.
• Ability to independently prioritize and execute projects in alignment with critical deadlines.
• Industry experience required.

Supervisory Responsibilities: None

Physical Demands:

While performing the duties of this job, the occupant is regularly required to:

• Prolonged periods of sitting at a desk and working on a computer.
• Prolonged use of computer and headphones for conference calls.
• Communicate effectively via phone, video, and email.
• Use hands and fingers to operate a computer and other office equipment.

Travel Requirements: Minimal