Overview: The Medical Writer will be responsible for researching, creating, and editing a wide range of clinical research documents. This role includes acting as the lead writer or submission coordinator for projects, managing the contributions of multiple writers, and serving as the primary client contact. Additionally, the Senior Medical Writer will play a key role in process improvement, providing technical mentoring and training, and supporting the management team in client liaison and proposal development during the sales process.

Key Responsibilities:

Author and edit regulatory medical writing documents, including clinical study reports, protocols, investigators brochures, informed consent forms, and other submission-related content.
Lead project management and coordinate with multiple writers on related documents.
Serve as the main point of contact for clients, ensuring seamless communication and delivery of high-quality documents.
Facilitate process improvements in the medical writing function and contribute to the development of best practices.
Mentor junior writers and provide training on writing techniques and regulatory guidelines.
Support the sales process by contributing to client proposals and liaising with potential clients.

Qualifications:

Experience: Minimum 6+ years of experience in regulatory medical writing, with proven ability in authoring key clinical documents.
Therapeutic Areas: Extensive experience across multiple therapeutic areas such as vaccines, immunology, autoimmune disorders, cardiovascular, endocrine, gastrointestinal disorders, infectious diseases, oncology, neurology, and mental health.
Skills: Strong communication, interpersonal, and analytical skills, with the ability to manage projects independently and lead teams.
Education: Bachelor's degree or advanced degree in life sciences, healthcare, or a related field.
Industry Background: Experience within the pharmaceutical or Contract Research Organization (CRO) industry.
Attention to Detail: A commitment to producing high-quality work with an exceptional focus on accuracy.
Workload Management: Ability to handle a variable workload and meet deadlines under pressure.

This role provides an exciting opportunity to lead medical writing projects, mentor others, and work across a variety of therapeutic areas while ensuring the highest quality standards.