Job Description
POSITION: MEDICAL WRITER , REMOTE
CAN BE 100% REMOTE - PRIOR EXPERIENCE IN ONCOLOGY IS A PLUS.
Work directly with program and clinical study teams, the Oncology medical writing teams, and the publishing group in the preparation of scientifically valid and high-quality regulatory and clinical documents.
Responsibilities include preparation of documents on behalf of client in accordance with the ICH guidelines, international regulations, client's standards and processes, and the client Writing Style Guide as applicable. Documents include but are not limited to: Protocols and protocol amendments, clinical study reports, investigator's brochures, and submission summary documents. Participate in project team meetings to provide input regarding deliverables, timelines, and processes. Responsible for managing the document review and completion process. The medical writer should be familiar with ICH guidelines and the current AMA Style Manual. The writer will be expected to manage large documents with multiple review cycles and tight deadlines.
QUALIFICATIONS:
Bachelor's degree (life science preferred), RN, Master's degree in life sciences, PharmD or PhD preferred; or equivalent experience.
Remote work is acceptable.
Excellent medical writing skills, meticulous attention to detail, proficiency using an electronic document management system and standard style guide, and strong analytical ability to interpret clinical data.
EXPERIENCE: 5+ years medical writing experience in the pharmaceutical industry.
Prior experience in Oncology is a plus. The most important requirement is the ability to independently write regulatory/clinical documents in collaboration with the study/program team members.
Company Description
Maxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience. Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.