We are looking for enthusiastic and talented individuals who thrive on challenge and change, and who want to make a difference through the delivery of results.
About the role: The Senior Manager, Medical Writing will manage and undertake medical writing activities, quality control (QC), staff training, and project management activities as lead medical writer for the ePDT.
Responsibilities:
Lead and manage individuals and teams to complete medical writing activities to appropriate quality standards and required timelines to support development of pipeline products.
Manage and coordinate medical writing activities as needed to support the early product development team.
Represent early product development team on the Medical Writing Leadership Team that oversees management, training, efficiency improvements, prioritization and issue resolution for the Medical Writing department.
Manage and oversee the work and any required training of direct line report(s).
Mentor new staff members, including contract writers, and deliver training, as required.
Take lead in organizing, managing and delivering clinical modules for regulatory submissions including IND, NDA and MAA related activities.
Identify and maintain working relationships with contractors/consultants/contract research organizations (CROs) for medical writing activities.
Ensure effective management of ongoing projects through establishment of regular subteam meeting schedules as needed.
Undertakes review of essential trial-related documents, as required.
Undertake QC checks on company documentation as requested, to required timelines.
Maintains GCP and Health & Safety knowledge as applicable to the job.
Required Experience:
Scientific graduate; PhD in Biomedical Sciences desirable.
Good knowledge of relevant regulations and legislation.
Knowledge of company SOPs.
Excellent written English with ability to interpret data and express findings in a clear and concise manner.
Excellent attention to detail.
Excellent organizational and time management skills.
Excellent communication skills including ability to work with colleagues across all clinical development functions.
Comprehensive computational skills, particularly in the use of Microsoft packages.
High level of numeracy.
Ability to be proactive, to work on own initiative and as part of a team.
Flexibility in meeting challenging deadlines and changing requirements.
Develops and maintains positive working relationships with others.
