Associate Director/Director of Medical Writing
Job Title: Associate Director/Director of Medical Writing
Location: Remote, US
Brio Resource Group is a Life Sciences Executive Search Firm committed to providing rare talent on an exclusive search basis to the Biopharma, Pharma, Device and CRO industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging Biopharma companies offering life-changing therapies. Our many years of experience, subject matter expertise, comprehensive search process and genuine passion to deliver rare talent defines Brio.
As a Medical Writer Associate Director/Director, you will be reporting to the Senior Vice President of Quality Assurance and Regulatory Affairs. This position is responsible for the development, preparation, and submission of regulatory documents for this organization.
- Author and review clinical and nonclinical medical writing for the organizations New Drug Application (NDA)
- Be the leader when interacting with cross-functional teams within the organization for the preparation of submission materials, such as timeline and project management activities
- Ensure the quality and accuracy of documents that are ready for submission using effective and established writing processes
- Collaborate with Regulatory, Clinical, and Nonclinical teams in order to prepare accurate, concise, and high-quality documentation that support the objectives of all the teams and their leadership
- Ensure that final medical documents follow SOPs (Standard Operating Procedures), GCP (Good Clinical Practice, and ICH (International Council on Harmonization) guidelines
Position Requirements: Bachelor’s Degree Required, Life Science Discipline
- 6+ years of medical writing experience within the biopharmaceutical industry
- Experience with medical writing for CNS regulatory filings
- Knowledge of regulatory guidance in relation to medical writing
- Strong understanding of the clinical drug development process, such as operations, clinical trial design, and results analysis
- Experience with Adobe Acrobat, Microsoft Office, as well as other standard software used for data analysis and regulatory document writing
We welcome the opportunity to provide a full job description upon resume review.
How to Apply:
In order to be considered for the above opportunity, simply apply via LinkedIn and include your CV.
We respond to applicants who meet our position requirements, but suggest submitting your resume for future consideration for our expanding list of new opportunities surfacing daily within our Biopharma network. We have a strict honor code at Brio respecting your confidentiality and we only share your information with your consent.
Brio Resource Group, LLC considers all applicants without regard to race, color, religion, sex, national origin, age, mental or physical disabilities, or any other similarly protected status.