Medical Writer Job at Artech Information System LLC, Pennington, NJ

WDN5Q0ltUGxvZWdtV3hvWmwra1QxN1oxS1E9PQ==
  • Artech Information System LLC
  • Pennington, NJ

Job Description

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

Job Tags

Similar Jobs

Keller Executive Search

Chief Marketing Officer (CMO) (Kansas City) Job at Keller Executive Search

 ...Our client is seeking a dynamic and experienced Chief Marketing Officer (CMO) to join their executive team. The CMO will play a pivotal role in shaping the brand's voice and driving marketing strategies that resonate with current and potential customers. In this position... 

Allied Universal®

Security Officer Part Time Weekends Job at Allied Universal®

 ...Universal, North Americas leading security and facility services company,...  ...workplace, you will be part of a team that contributes to...  ...comprehensive benefits for most full-time positions, including medical,...  ...: Part-time Overnight shift (7:00 PM 7:00 AM) Requirements... 

Aerotek

Entry Level Billing Specialist Job at Aerotek

 ...Aerotek has an immediate internal opening for an Entry Level Billing Specialist at our corporate headquarters in Tempe, AZ ! About...  ...Full Time | Monday - Friday Hybrid Schedule | 4 days in office - 1 day remote Compensation | $21.63/hr ($45,000 annually)... 

DAVITA

registered Nurse Job at DAVITA

Posting Date 07/21/20251013 East 16th Street,Cordele,Georgia,31015,United States of America DaVita is seeking a Nurse who is looking to give life in an outpatient dialysis center. You can make an exceptional difference in the lives of our patients and their ...

Avila Construction Company

Construction Safety Coordinator Job at Avila Construction Company

Construction Safety Coordinator Job Description Avila Construction is seeking a detail-oriented and proactive Construction Safety Coordinator...  ...with superintendents, project managers, subcontractors, and office staff to promote and enforce a culture of safety and...