- Job Title
- Medical Writer
- Job ID
- WEST HOLLYWOOD, CA 90069-3704
- Other Location
Oncotherapeutics is a full-service Contract Research Organization (CRO) with a unique focus in the therapeutic area of oncology. We are a strategic CRO running multiple clinical trials in community oncology sites throughout the United States (US). We provide necessary support to major biopharmaceutical companies throughout the US to successfully run, enroll and completion of clinical trials. Uniquely focused on community-based Hematology & Oncology research sites, we provide real-world experience, data and outcomes that lead to improved clinical utility of cancer therapies, improving the lives of cancer patients
We hire exceptional people. We want individuals who thrive on being challenged and are passionate about building a great company as well as growing with us. If you want your next step to be the right one and you've worked hard to get where you are today, then we have the perfect opportunity for you.
We are looking for a stellar Medical Writer who will be responsible for clinical and regulatory documentation to support ongoing and new clinical trials. This ideal candidate will be responsible for articulating scientific ideas into concept and study synopsis, developing, and maintaining clinical/regulatory documentation, analyzing clinical trial data.
- Developing scientific concepts and synopsis from scientific ideas
- Write the clinical regulatory documents including but not limited to INDs, IND Amendments, ICFs, IND annual reports, Clinical Trial Registry records
- Perform clinical data analysis in preparation for manuscripts, abstracts, posters, and oral presentations
- Perform literature searches as needed for drafting document content
- Author and prepare publications including abstracts, manuscripts, posters, and oral presentations
- Work in close collaboration with the Medical Director/Lead Principal Scientist, and project and data managers to facilitate and complete writing projects
- Review, edit, and format all writing projects
- Advanced degree in Life Sciences or a clinical field of study (MD, PhD or PharmD)
- 1-3 years of clinical/regulatory writing experience
- 1-3 years of experience in the areas of hematology and oncology is preferred.
- A minimum of 3 years of experience in writing clinical, scientific manuscripts, preferably in the areas of hematology and oncology
- Experience in data handling, organizing, and analysis. A good understanding of basic clinical statistical principles and tests applied in clinical trials is preferred (e.g. samples size calculations, PFS, OS, ORR, and CBR)
- Previous experience in writing regulatory documents for Phase I- IV clinical trials (preferred)
- A basic understanding of the requirements for US regulatory submissions (preferred)
- Computer proficiency (Microsoft Office, Adobe Acrobat, Excel, GraphPad, etc.)
- Strong attention to details
- The ability to work independently and in a team environment
- The ability to multitask and manage multiple competing tasks and demands while completing them on the specific deadlines
- Excellent organizational skills
- Excellent communication (oral and written) and interpersonal skills
This is a high growth, fast paced small organization. The ability to be productive and successful in an intense work environment is critical.
We value our employees’ time and efforts. Our commitment to your success is enhanced by our competitive compensation and an extensive benefits package including paid time off, medical, dental and vision benefits and future growth opportunities within the company. Plus, we work to maintain the best possible environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where each person feels encouraged to contribute to our processes, decisions, planning and culture.We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.