Medical Writer Position
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