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
TECHNICAL KNOWLEDGE:
• 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.
QUALIFICATIONS AND SKILLS NEEDED:
• 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.
• Experience with oncology and eCTD filing preferred.
Tel: 732-429-1921
http://www.irionline.com
Job details are sourced from the employer's original posting.
Open job postingAbout the company
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.