Job Description
Senior Medical Writer
Completes assignments independently or for more complex documents, under guidance of a mentor
Authors a range of clinical documents, including regulatory documents following defined templates, including but not limited to protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions.
Ensures high integrity of data interpretation, following negotiation with document team.
Ensures the consistency and quality level of all documents that are issued.
Actively participates in all planning, coordination and review meetings.
Ability to work on 2-3 assignments simultaneously.
Proactively raises and discusses concerns/ issues in an open and timely manner and within the global team, thereby demonstrating the ability of promoting high medical writing standards by pointing out obvious flaws and proposing (and advocating) alternatives.
Establishes network of communication and continuously builds collaboration to facilitate smooth partnerships and interfaces between all groups involved in delivery of writing assignments.
Principal Medical Writer
- Develop the tools and environment to support risk management and management monitoring activities defined by the Head, Scientific Writing Business Excellence, including data collection, tracking, reporting, assessment, and presentation
- Implement process management practices within Scientific Writing while verifying/validating project results and serve as the main point of contact for document retrieval
- Lead Scientific Writing-led process improvement initiatives, change management, and the implementation of Standard Operating Procedures (SOPs) and business guidance/working standard
- Develop training material and toolkits for the Scientific Writing teams, including onboarding external collaboration, tracking training compliance for Scientific Writing including external collaborators
- Support the Head, Scientific Writing Business Excellence in ensuring audits, independent monitoring and inspections related to Scientific Writing are adequately supported, tracked and outcomes requiring corrective action are managed to quality requirements
- Track findings, observations and Corrective and Preventive Actions (CAPAs) related to Scientific Writing, ensuring all information are readily available and retrievable, assessing weak points/gaps across Scientific Writing and ultimately coordinating training initiatives accordingly
Develop team expertise in areas of interest or specific talent including:
- risk facilitation, management monitoring and performance
- process improvement, training, audit, assessment and inspection
- change management, capacity building, toolkit generation, documentation/archiving
