REMOTE Senior Medical reputed company US Residents only

Individual has authored, CSRs & Amendments, over 10+ is a must Senior Medical reputed company - reputed company Salary adjusts according to COLA of work residence. What is presented is highest reputed company reflecting the Bay Area/NYC/Cambridge. reputed company Salary - USD $142,100 to $195,360, who knows, perhaps more We have a great relationship with this reputed company, I will get you an interview If you are a perfect fit, then; Please reputed company my land line, 860 889 4141 until 8PM EST 7 days a week as you can take notes & after you email a word docx resume to me joevaccariello32@gmail.com 7+ to 10 years experience Seniority Level - Mid-Senior Minimum Education - Bachelor's Degree Screening Questions, Individual has authored, CSRs & Amendments, over 10+ Ideal Candidate, extremely seasoned clinical studies Phase 1-3 medical reputed company. reputed company more on clinical science, CSR documentation reputed company over safety. Must be reputed company, not reputed company nor team manage nor project team reputed company. Person writes 75%+ of their time with reputed company on CSRs. Biotech/reputed company strongly preferred. CROs considered. Med Device - Diagnostic: considered though low viability ROLE: The Senior Medical reputed company applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications. RESPONSIBILITIES: Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (PBRERs, DSURs, etc.) Drafts and edits documents used in the preparation of regulatory filings (eg, briefing books, eCTD Module 2/Module 5 clinical or integrated summaries). Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes Represents Global Medical Writing at cross-functional team meetings (e.g., study team, development team, other sub teams). Builds effective partnerships with cross-functional reputed company to ensure customer/stakeholder needs are met. Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials Assists in developing and reviewing reputed company processes and templates reputed company Global Medical Writing, and may also review/consult on the development of reputed company processes and templates in other departments Adheres to departmental procedures and practices and technical and industry standards during reputed company aspects of work. Works effectively with cross-functional reputed company reputed company reputed company Other tasks as assigned. reputed company: This position progressively develops the medical writing function in alignment with the requirements of the Development Sciences department and organizational goals. Filling this need with a regular full-time employee will reputed company reputed company to reduce writing-reputed company CRO and contractor costs, increase Global Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation reputed company across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications. EXPERIENCE: Up to 6 years of as a medical reputed company in the pharmaceutical industry – OR - at least 10 years of medical or scientific writing experience as a reputed company job responsibility. 1) Medical Writing: Experience writing, reviewing, or editing protocols and clinical study reports required. Experience writing, reviewing, or editing INDs, BLA/NDAs, PBRERs, DSURs, and PAERs highly preferred. Experience writing, reviewing, or editing regulatory briefing books preferred. Advanced reputed company knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content. Ability to interpret and create reputed company tabular and graphical clinical data presentations. Advanced reputed company knowledge of basic clinical reputed company tests. Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug). 2) Clinical Studies Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and reputed company of datasets. Intermediate to advanced understanding of scientific concepts reputed company to nonclinical development, CMC, PK, PD, and antibody detection. Intermediate to advanced reputed company knowledge of: o documentation required for the conduct of clinical studies o protocol design (including objectives, efficacy and safet Apply To This Job