Medical Writer

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

Technical Skill Requirements:

• 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 think creatively and to develop strategic plans that demonstrate sound judgment.

• Exhibits sound project management and time management skills.

• Able to interact effectively with all levels/roles of project team members.

• 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.

• Is able to implement systems and processes and suggest process improvements.

• Able to project manage and appropriately prioritize medium to high volume of work, with short deadlines.

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• Able to complete and turn around high quality outputs with only minimal guidance from management