Job Description

• Writing of study reports for non-interventional and clinical studies
• Preparation of manuscripts, posters and abstracts
• Preparation of other project-specific documents such as observational plans and study protocols
• Creation of components of submission dossiers (modules of the Common Technical Document [CTD]) and safety reports (Periodic Benefit-Risk Evaluation Reports [PBRER] / Periodic Safety Update Reports [PSUR], Post Market Surveillance Reports [PMSRs] and Development Safety Update Reports [DSUR])
• Providing advice to Sponsors on the most appropriate presentation of data in the light of regulatory agency requirements as well as on interpreting and describing data
• Supports Drug Safety Officer in creation of narrative safety reports and corresponding inquiries
• Develops relationships with clients and is considered a junior point of contact by clients for project requests / questions
• Assists in writing simple proposals and methodology sections of more complex proposals with input from senior team members
• Prioritises workload without major input from Team Leader Medical Writing to ensure agreed deadlines are met
• Develops own knowledge and personal skills in line with business requirements
• Keeps abreast of developments in the pharmaceutical industry
• Execute job responsibilities as directed throughout the transition period to ensure continuous client service and business operations
• Attend and actively participate in transition related meetings and informational sessions
• Contribute to team knowledge base and information sharing
• Expand network to broaden working relationships with Cerner colleagues

Qualifications:

• Master's degree in life sciences subject
• Medical writing experience within a CRO, life science, pharmaceutical or medical organization
• Ability to work within timeframes and deliver
• Ability to manager several projects at once

Responsibilities

Intermediate-level position who is responsible for applying scientific, clinical, and healthcare knowledge to provide solutions to customers.  Apply best-in class research theories and methods to deliver an optimal solution build and implementation.  As a member of team, exercises judgement within defined procedures to introduce innovative research collection and analysis methodologies on external customer engagements.  Work involves using analytical skills sufficient to interpret data/ instructions and applying the relevant research techniques with some autonomy.   Receives general instruction on new projects or assignments.  Makes recommendations to enhance performance and research results.   Possesses solid knowledge in reference to creating project and client related research materials.