- The MD 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 MD 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
- Achieved through application of team-working approaches this individual will create and foster an environment of partnership with other members of product teams
- 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 WSRO, and with WSS/WRS, Development Operations, Clinical, Pfizer Country Offices and other key stakeholders
- Scientific/medical academic background (e.g., PharmD/PhD or MSc/BSc with experience), or equivalent
- Displays an understanding of the scientific basis for drug-induced diseases
- 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 non-scientific audiences
- Applies expert knowledge, analytical skills, and knowledge of clinical and regulatory guidance
- Able to clearly articulate scientific and clinical data in all written and verbal communication
- 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
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