- Contract Opportunity
- Remote Work - Work from Home
- 2 locations available - United States or Belgium
- Once travel restrictions are lifted, there will be travel to Boston MA or Ghent Belgium 1-2 times a month
- Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. Demonstrates subject matter and therapeutic area expertise. May assist program manager. Collaborates with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.Essential Functionsand Other Job Information: Essential Functions•Serves as primary author who writes and provides in
- Serves as primary author who writes and provides input on routine documents such as clinical study reportsand study protocols, and summarizes data from clinical studies.
- May research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
- Participates in project Launch Meetings, Review Meetings, Project Team meetings, and audits as required.
- Assists business development and senior management in securing new business by preparing and making presentations to clients.
- May prepare complex documents and provide senior review. Maintains knowledge and understanding of PPD SOPs, Client SOPs/directives, and current guidelines regarding clinical trials, documents and other submissions and provides guidance to others as needed.
Education and Experience:
- Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5 years).Experience working in the pharmaceutical/CRO industry preferred
- Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
- Strong project management skills
- Excellent interpersonal skills including problem solving
- Strong negotiation skills
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of global, regional, national and other document development guidelines
- In-depth knowledge ina specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
- Great judgment and decision-making skills
- Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)