Medical Writer

Description

• Apply 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 (contractors) authors.

• 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.
• Collaborate with development Product Teams to prepare or lead preparation of Clinical/Regulatory documents.
• 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.
• Manage contract writers, as well as internal writers.
• 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.
• 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.
• 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

• 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.
• May also include
• Able to project manage and appropriately prioritize medium to high volume of work, with short deadlines
• CTD Modules for NDAs and MAAs: 2.5 clinical overview, 2.7. 1 biopharmaceutics and associated analytical methods, 2.7.2 summary of clinical pharmacology studies, 2.7.3 summary of clinical efficacy, and/or 2.7.4 summary of clinical safety.
• Experience with oncology is also desirable.
• MS Word
• Must have clinical NDA Submission Experience.