Entry Level Medical WriterOur Client is committed to advancing oncology care by developing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of cancers.Job Description Writes, and edits, as necessary, clinical protocols/amendments, annual reports to regulatory authorities, clinical study reports, regulatory documents (eg, clinical sections of an IND, dossiers, or a BLA/NDA), ad hoc clinical reports, publications, and related documents. Writes, and edits, as necessary, departmental Standard Operating Procedures (SOPs). Assists with the integration of clinical trial data/information into concise and uniform reports for journal submission or non-routine submission to regulatory authorities. Assists with the circulation of clinical/medical data/information via reports to departmental and Company employees as directed. Prepares timely summary reports of the status of all responsible projects. Assists with the interaction of database management staff (either in-house or vendor) to provide appropriate data output for the timely completion of required responsibilities. Maintains technical proficiency and professional skills of self through literature review and attendance at conferences, seminars, courses, or clinics. Follows departmental policies, procedures, and SOPs. Provides a leadership role within the Medical Information department by independently planning, developing, reviewing, and coordinating medical writing activities. Oversees the completion of assigned data presentations utilizing clinical/medical data/information. Interacts with other departments to provide the clinical/medical data/information necessary for the timely completion of their work. Job Requirements ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE: 0 â 2 years of progressively increasing experience, either in clinical affairs, medical writing, or regulatory affairs, within the pharmaceutical industry. A working knowledge of Food and Drug Administration’s regulations, Good Clinical Practices guidelines and industry recommendations for the conduct of clinical investigations. Ability to identify inconsistencies between case report form data and the output of the clinical database, or of current clinical trial status reports, or other administrative or clinical problems, and resolve them with minimal supervision. Ability to deliver oral presentations and write regulatory documents, summary reports, and SOPs in a clear, focused, and concise manner. Ability to achieve departmental and Company goals in a timely manner Salary: $90K-$95K annual. Medical Staffing Network is one of the largest and most reputable Clinical Research staffing agencies. As an MSN employee, youâll receive great pay and top benefits. Why choose Medical Staffing Network? 401K Major Medical, Vision and Dental Insurance Life Insurance and Short Term Disability Liability and Workers’ Compensation Enjoy: Great locations/ prestigious facilities Exclusive partnerships APPLY NOW, email your CV or resume to clinicalresearch@msnhealth.com , or contact us at (877) 605-2500. To be considered for this opportunity, ALL candidates MUST be working in the biotech/pharmaceutical clinical trial industry. No one outside industry will be considered. Due to the high volume of responses, only inquiries from qualified candidates can be addressed. medical writer, pharmaceutical, clinical research, clinical trials, Bridgewater, Morristown, Maplewood, Union, Elizabeth, Westfield, Rahway, Iselin, Perth Amboy, Edison, Middlesex, New Brunswick, East Brunswick, Manville, Somerville, Clinton, High Bridge, Hampton, New Jersey, NJFor quick consideration apply here
Medical Writer Job in Bridgewater 08807, New Jersey US