Artech Information System , a global staffing and IT consulting company, is constantly on the lookout for professionals to fulfill the staffing needs of our clients. We currently have a job opening that may interest you. Job Description Position: Medical Writer Duration: 6 Months Job Description: Scientific Writer for Aggregate Reports: Coordinate and author documents needed for regulatory submissions (e.g., CSRs, CTD summary documents, aggregate safety reports, risk management plans), ensuring the coordination and integration of the scientific, medical, and regulatory input from cross-functional team members. Participate in relevant document sub team(s) and ensure effective planning and management of timelines for all components of assigned documents. Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects. Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents. Review and edit documents as required. Considerable experience in assignment on cross-functional teams would be an advantage. Qualifications: PhD/MD/PharmD in a relevant scientific discipline or MS/BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, or equivalent, with a good understanding of requirements for regulatory submission documents. Demonstrated strong writing skills as evidenced by good quality writing in pharmaceutical regulatory documentation and/or publications in peer-reviewed journals. Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities. Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills in a cross-functional team. Working knowledge of a document management system and basic knowledge of document publishing process. Ability to analyze and interpret complex data from a broad range of scientific disciplines. When assigned as Lead Writer, ability to lead other writers, including developing strategies/plans and managing projects, in order to complete multiple documents for regulatory submissions. Demonstrate mastery of complex writing assignments (e.g., Phase III CSRs, CSS, CSE, Background Packages, etc.) across therapeutic areas or multiple projects. Participate in relevant filing subteam(s) and ensure effective planning and management of timelines for all components of assigned documents. Lead or co-lead (with Doc Lead) teams to define content and data displays for CSR prototypes and shells. Able to collaborate with project team to respond to health authority questions, requests, etc. Provide departmental management with adequate information to help assess resource needs. Additional Information All your information will be kept confidential according to EEO guidelines. #J-18808-Ljbffr Artech Information System LLC
...Come work at the Addison Airport Office Center! We need an office cleaner who can start immediately for nighttime cleaning. Located near Addison Circle, our building is home to the regional airportsee planes while you work! Benefits and Perks: ~ Pay: $18/hour ~...
...types of locations while maintaining timely claims submissions. Registers patients and completes necessary documentation including insurance verification and benefits determination. Research charges to submit to appropriate carrier according to Federal/Managed Care rules...
...Berkel & Company Contractors, Inc. is seeking a Survey Technician for our regional office located in Silver Spring, MD. This field-based... ...s degree in a technical field preferred. ~ Professional Land Surveying License preferred but not required. ~2+ years experience...
...alongside an experienced dentist About the COMP & BENEFITS: Excellent Salary PTO Clinic pays for full family medical and dental insurance, individual life insurance, and professional liability Matching IRA after 12 mos. 6 paid holidays & 1 floating...
...inclusive working environment, including culture of rewards, recognition, and respect Position Purpose: Food and food service delivery Drivers fulfill a critical role in the countrys food supply chain. Our delivery drivers not only make sure the customers...