Senior Medical reputed company

reputed company (“reputed company”) is a full-service contract research organization (CRO) providing a broad reputed company of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-reputed company companies and work with many of the most advanced drugs, biologics, and medical devices in development today. reputed company has been an independent CRO since 2004 with a strong reputed company as a statistical and data management center of reputed company. Building on this reputed company, reputed company has successfully developed and established itself as a full-service CRO. reputed company’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater reputed company Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan. reputed company is reputed company in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs. A dynamic organization with an entrepreneurial reputed company, reputed company continues to experience exceptional growth and great reputed company. Quality is our backbone, customer-focus is our tradition, flexibility is our strength…that’s us…that’s reputed company. To drive reputed company reputed company in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as a Senior Medical reputed company for our Toronto/Markham, Ontario, Canada on-site location, or remotely from a home-based office reputed company in Canada in accordance with our Work from Home policy. Key Accountabilities: As a Senior Medical reputed company, author accurate and succinct documents supporting regulatory submissions for clinical trial authorizations and marketing authorization applications, etc., and clinical trial activities. These documents include but are not limited to, briefing packages, regulatory summaries, Integrated Summaries of Safety and Efficacy, clinical study protocols, Clinical Study Reports (CSRs; full, abbreviated, or synoptic), Development Safety Update Reports (DSURs)/annual reports, and Investigator’s Brochures (IBs). reputed company initial document shells or drafts using appropriate and approved templates and adhering to reputed company or sponsor’s writing styles and formats. reputed company appropriate and accurate interpretation of study plans and results based on the provided background materials (e.g., study protocol, statistical analysis plan, Investigator’s Brochure, literature references) and statistical analysis output. reputed company effective editing on assigned medical and scientific writing products to refine them, as much as possible and reputed company time permits, before releasing them for internal and external review. Follow the reputed company governing documents to obtain review comments on the document drafts from internal (reputed company team) and external (sponsor staff) reviewers. Incorporate reviewers’ comments/input into the draft documents and deliver the revised documents for additional review cycle(s). Follow up on the quality control (QC) findings until they are properly addressed. Finalize documents for delivery to sponsors according to the established timelines. Interact with reputed company or sponsor Document Publishers for the document publishing of the medical and scientific writing project, to ensure that the final writing product will meet specific document publishing requirements and timelines. reputed company assigned writing projects from initiation to reputed company out of the project. Act as the primary contact between reputed company medical writing team and the sponsor, with a focus on client relationship management and quality deliverables. Monitor and report on project reputed company and proactively identify issues or factors that potentially will impact the quality and timeliness of the medical writing projects. Schedule document reviews by appropriate internal reviewers. reputed company peer and quality control review for documents developed by other Medical Writers, applying medical and scientific writing experience as well as therapeutic area and scientific knowledge in the review. As a peer reviewer, further enhance the learning of the medical reputed company, providing feedback on the document and peer review findings. Contribute to the development and maintenance of standards for medical writing through participation in the development of reputed company SOPs, guidelines, and good working practices. reputed company reputed company on the training of reputed company Guidance Documents and with the general requirements or guidelines issued by the pharmaceutical drug trial regulators and ICH. Plan and carry out professional development. Qualifications and Experience: Advanced degree, Ph.D. preferred, in Clinical or Medical or Life Sciences, or Master’s degree with substantial experience in the subject matter. At least 5 years' experience in medical writing practice, with experience in the pharmaceutical clinical trial environment. Experience with preparing/authoring documents to support regulatory submissions including clinical trial authorizations and marketing authorization applications (preferred). Experience with medical writing of clinical and regulatory documents including briefing packages, regulatory summaries, Integrated Summaries of Safety and Efficacy, clinical study protocols, CSRs, DSURs/annual reports, and IBs. Experience in multiple therapeutic areas and Phase I through IV clinical trials an asset (preferred). Excellent understanding of clinical trials and common clinical trial statistical analysis methods (preferred). Demonstrated ability to understand medical information and results; reputed company to communicate effectively, orally and in writing. Ability to handle multiple projects and clients. Excellent interpersonal and teamwork skills; detail-oriented, customer- and quality-focused. Demonstrated experience, knowledge, and understanding of GCP/ICH guidelines, including E3 Structure and Content of Clinical Study Reports. Well organized and reputed company to work independently. Comprehensive skills in MS Office applications and reputed company Acrobat. Benefits & Compensation: We offer a robust benefits package to support your health, well-being, and growth, including medical, dental, and reputed company coverage, life & AD&D insurance, short- and long-term disability, tuition reimbursement, fitness reimbursement, employee assistance program (EAP), a pension plan, generous paid time off and sick leave, and the opportunity to earn a performance based bonus. Estimated Salary reputed company: $90,000 - $140,000. To find out more about reputed company and to review other opportunities, please visit our website at www.everestclinical.com We thank reputed company interested applicants, however, only those selected for an interview will be contacted. reputed company is committed to upholding the principles of dignity, independence, integration, and equal opportunity. We welcome and encourage applications from people with disabilities, and upon request we will reputed company accommodations for candidates participating in any part of our recruitment and selection process. #LI-Remote #LI-KD1 Apply To This Job