Cream City Studios is seeking a highly skilled and motivated Medical Writer to join our dynamic team. In this role, you will play a crucial part in communicating complex scientific information effectively while ensuring accuracy and clarity in all documentation. As a Medical Writer, you will be responsible for creating a variety of documents including clinical study reports, regulatory submissions, publications, and educational materials for healthcare professionals. You will collaborate closely with cross-functional teams including clinical research, regulatory affairs, and medical affairs to ensure that all written materials meet the highest standards of quality and comply with regulatory requirements. Additionally, you will be involved in the preparation of manuscripts, presentations, and other scientific documents that contribute to the advancement of our projects and therapies. We are looking for a detail-oriented individual with a strong background in medical writing and a passion for translating complex information into accessible content. If you are looking for an opportunity to make an impact in the healthcare industry and work with a talented group of professionals, Cream City Studios would love to hear from you!

Responsibilities

• Create and review clinical study reports, protocols, and informed consent forms.
• Prepare regulatory submission documents in compliance with FDA and EMA guidelines.
• Develop and author scientific publications for peer-reviewed journals.
• Collaborate with cross-functional teams to gather necessary information for documentation.
• Ensure consistency and adherence to internal style guides and template standards.
• Edit, revise, and proofread documents to ensure quality and accuracy.
• Stay updated on industry trends and regulatory changes affecting medical writing.

Requirements

• Bachelor's degree in Life Sciences, Medical Writing, or a related field; advanced degree preferred.
• Minimum of 3 years of experience in medical writing or related field.
• Strong knowledge of regulatory requirements and guidelines for clinical documentation.
• Excellent writing, editing, and proofreading skills with a keen eye for detail.
• Ability to communicate complex scientific concepts clearly to various audiences.
• Proficient in Microsoft Office Suite and familiarity with document management systems.
• Strong organizational skills with the ability to manage multiple projects and deadlines.

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)
• Short Term & Long Term Disability
• Wellness Resources