A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
The Medical Writer is responsible for medical documentation summarizing risks and benefits in support of the development, license application and approval, and post-marketing development of one or more drug products. This will be achieved by applying analytical skills, functional literacy and expertise in document preparation.
Responsibilities:
• Prepare the Clinical Overview, integrated safety, efficacy, pharmacology and bio therapeutic summaries, regulatory responses, internal and external risk/benefit briefing documents, for one or more assigned products.
• High quality written presentations of Common Technical Document Efficacy components that are compliant with regulations, ICH guidelines, and corporate SOPs.
• Communicate resource, timeline and emerging data interpretation issues that have regulatory impact, to the project team and line management.
• Develop and sustain constructive relationships within WSR, and with Development Operations, Clinical, and other key stakeholders.
• Collaborate with development Product Teams to prepare or lead preparation of Clinical/Regulatory documents.
• Ensure key messages and document style are communicated to authors and team to ensure consistency across different documents.
• Manage contract writers, as well as internal writers.
• Highly organized, ability to prepare technical reports, summaries, protocols, and quantitative analyses.
Qualifications:
• Scientific/medical academic background (e.g., MD, DVM, PhD in relevant field, BSN, PharmD, Master's or Bachelors' degree in relevant field), or equivalent.
• Strong functional literacy is desirable: for example a track record of communicating complex information and analyses effectively in writing to a variety of scientific and nonscientific audiences. Applies expert knowledge, analytical skills, and knowledge of clinical and regulatory guidance.
Additional Information:
• Able to work well in cross-functional teams, exhibiting a combination of active listening skills and also the confidence to guide decision-making for the document content strategy.
• Able to manage expectations and the time pressures associated with authoring, resolving comments, updating and finalizing documents.
• Able to complete and turn around high quality outputs with only minimal guidance from management.
...Commercial Roofing EstimatorPrepares roofing estimates analyzing job/project/RFP requirements, technical drawings and associated specifications. Previous experience is required.Skills/Qualifications:Metal and roofing estimating knowledge with the ability to interpret and...
...New Bedford Public School District PRAB - Special Education - New Bedford, Massachusetts Open in Google MapsSpecial Education Supervisor... ...responsibilities as may from time to time be assigned by the Executive Director of Special Education and Student ServicesThe above...
Premier Transportation seeks CDL Lease Purchase/Owner Operator Drivers to move freight safely and efficiently for our dedicated customers. As an independent contractor, youll operate late-model equipment, manage your business, and enjoy consistent freight in a supportive...
...completed on time, on budget, and built to the highest standards. Our client is seeking an experienced and hands-on Senior Construction Accountant to lead the companys accounting and financial operations. This role will oversee day-to-day accounting functions, ensure...
...increase - Regional Van Truckload truck driver - home weeklyAverage... ...time: WeeklyExperience: All CDL holdersOverviewPredictable power... ...freight allows for maximum drive time and less down time.Dispatched... ...miles of Wilmer, TX.Need CDL training? Explore our company-paid CDL...