Description
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 summaries, responses to regulatory questions, safety updates 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. 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 authors.
Primary 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.
- 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, and with Development Operations, Clinical, Country Offices and other key stakeholders.
- Collaborate with development Product Teams to prepare or lead preparation of Clinical/Regulatory documents.
- 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.
- Manage contract writers, as well as internal writers.
Skills/Qualifications:
- 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.
- Able to complete and turn around high quality outputs with only minimal guidance from management.
- Scientific/medical academic background (eg, MD, DVM, PhD in relevant field, BSN, PharmD, Master's or Bachelors' degree in relevant field), or equivalent.
- MDA submission experience.
- 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.
- 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.
- May include a track record of leadership abilities either as a direct supervisor or within a Matrix.
- Medical writing experience with clinical efficacy and safety summaries in CTD format; ability to think strategically and work collaboratively within project team; knowledge/experience with writing oncology documents is a plus.
- MS Word.