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.
Location: Groton, CT
Duration: 3 years+
Our client is looking to hire the Medical Writer
Job Description:
• Company is looking for medical writers with experience submission on the CTD Modules for NDAs and MAAs, clinical overview, biopharmaceutics and associated analytical methods, summary of clinical pharmacology studies, summary of clinical efficacy, and/or summary of clinical safety.
• Experience with oncology is also desirable.
• The Author will provide 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.
• The author will contribute essential deliverables which could include clinical overviews, integrated analyses of safety and efficacy summaries, responses to regulatory questions, safety updates and regulatory briefing documents.
• May also, in collaboration with the Project Team, assess document requirements, complexity, and potential issues with a submission, and develop strategies to deal with these, and lead a team of internal and external (contractors) authors.
PRIMARY 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.
• Skills 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.
May also:
• Collaborate with development Product Teams to prepare or lead preparation of Clinical/Regulatory documents.
• Identify resource, timeline and emerging data interpretation issues that have regulatory impact, and clearly communicate the consequences of these issues to the project team and line management.
• Serve as the point of contact ("go to" person) for one or more projects or products.
• Organize and lead a MD matrix team of authors to deliver all MDL deliverables for each assigned project.
• Ensure key messages and document style are communicated to authors and team to ensure consistency across different documents.
• Exhibits sound project management and time management skills.
• Able to manage expectations and the time pressures associated with authoring, resolving comments, updating and finalizing documents.
• Demonstrates proactive nature in taking on assignments and readily mentors other colleagues in area of expertise.
May also include:
• Able to project manage and appropriately prioritize medium to high volume of work, with short
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