Medical Writer

The Medical Writer is responsible for 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.

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.

• 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.

 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.