Clinical Scientist/Regulatory Writing

Fahrenheit IT in Chester, PA

  • Industry: Scientific Research - Health/Medicine/Pharmacology
  • Type: Full Time
position filled
Id: 166670 Location: Malvern, PA Job Type: Contract One of our leading clients, an international. Pharmaceutical company focused generics and specialty branded drugs is seeking a Clinical Scientist/Writer Consultant provide medical and scientific study and project support for multiple, global, Phase 1-4 clinical studies in a clinical program . Medical Writing Scientist responsible for working collaboratively with the Clinical Program Lead to develop study strategies in support of the clinical plans. We are hiring a Medical Writing Scientist for our client, a leading pharmaceutical located in Malvern, PA, Medical Writing Scientist working with clinical development team to prepare clinical regulatory documents to support development programs throughout the product lifecycle. As a Medial Writing Scientist you are responsible for preparing complex clinical study documents and sections of regulatory submissions to support all phases of clinical drug development. You are scientific contributor and subject matter expert for clinical regulatory documentation, and you will work with medical writers, quality control reviewers, and cross-functional teams. You may work in Malvern, PA with flex time/flex day. Qualification: Master's Degree or PhD (or equivalent degree) and 5-10 years of pharmaceutical industry Medical Writing experience. Following are the key skills/experience we are looking in candidates for Clinical Development team: Clinical Development/ Scientific lead in phase 1-4 clinical trials Clinical pharmacology knowledge/experience 'Concept Development to POC (Proof of concept)', 505b2 NDA experience Experience in CSR, CTD Modules 4/5 , journal article abstract/manuscript writing Ample experience in closely collaborating ClinOps, Data Management and Biostats teams in clinical studies Key Responsibilities: Independently prepare clinical regulatory documents, including protocols, study reports, investigator's brochures, and sections of regulatory submissions Participate in developing key messages for complex clinical regulatory documents Provide medical writing input for study designs and statistical analysis plans May be the lead writer for multiple clinical development programs or therapeutic areas Provide expert review of documents Actively identify process and template improvements Provide expert-level input to teams that work on standard operating procedures and process improvements, and integrations of new tools and technologies Extensive experience writing and editing clinical regulatory documents Ability to analyze, interpret, and summarize highly complex data Advanced understanding of drug development, clinical research, and regulatory requirements Prioritization skills and ability to handle multiple complex projects Excellent written communication skills As a well-funded pharmaceutical company, company pays highly competitive hourly rate based on W2/1099 and Corp-to-Corp. Interested individuals are encouraged to contact or submit their CV to the following email address: or call Rose Chu at 610-###-#### for discussion. Search Terms: Medical Writer, Scientific Writer, Clinical Writer, Clinical Scientist, Principle Medical Writer. Principle Medical Writing Scientist, Sr. Scientific Writer, Medical Writing, Science, Protocol Writing We appreciate your understanding, in that; we will only be able to respond to those inquiries who meet the stated requirements. To protect our client's interests, we will not be responding to inquiries that do not contain a CV/Resume. Finally, please include the position ID (rc-Scientific Writer ) in the subject line of your correspondence to ensure review. Please forward your credentials in Word format through Indeed or call Rose Chu at 610-###-#### for questions. Our clinical recruiter/manager will contact the qualified candidates IMMEDIATELY to set up interviews. Rose Chu Vice President - Pharmaceutical, CRO, Biotech, Medical Device Global Employment Solutions/Fahrenheit IT P (610)###-#### | C (215)-###-#### | F (610-###-####) | One Presidential Blvd. North, Suite 310, Bala Cynwyd, PA 19004 We're looking for hot talent Tell your friends and get $250 plus a new iPad 2, iPad Mini, Apple Sport Watch or iPod Touch. Sign up - provided by Dice
Associated topics: editor, editor writer, fda, law, medical writer, regulatory, regulatory affairs, write, writer, writing

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