Technical Associate

Job Description-

• 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, responses to regulatory questions, risk management plans, REMS, key sections of the Investigator’s Brochure, the Annual Safety Report and regulatory briefing documents. 

• Individual will create and foster an environment of partnership with other members of product teams, 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. 

RESPONSIBILITIES: 

• Prepare the Clinical Overview, integrated safety, efficacy, pharmacology and biotherapeutic summaries, regulatory responses, internal and external risk/benefit briefing documents, for one or more assigned products.

• For submissions, ensure high quality written presentations of Common Technical Document Efficacy components that are compliant with regulations, ICH guidelines, and corporate SOPs. 

• Author documents such as agency briefing documents, key sections of the Investigator’s Brochure, the Annual Safety Report and the core data sheet.

• 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.

• Collaborate with development Product Teams to prepare or lead preparation of Clinical/Regulatory documents (MD deliverables).

• 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