Director, Medical Writing
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Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
About this role
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities resourcing and Functional Service (FSP) solutions.
The (job title) is responsible for timely delivery of high-quality clinical regulatory-compliant documents.
As part of our SRS/FSP team you will be dedicated to one sponsor a global pharmaceutical company.
Please keep in mind that this is a full-time hybrid role with 3 days in the office in Warsaw Poland.
Key Responsibilities
Provide clear leadership and accountability strategic vision and planning direction at the global function level for clinical regulatory documents.
Review to ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards.
Ensure consistent support and implementation of MW standards and maintain adherence to standard operating procedures and regulatory requirements in partnership with statistical clinical regulatory quality and drug safety colleagues.
Work in close collaboration with the MW team to drive best practices and support for innovation capabilities efficiency and resourcing.
Qualifications
Significant experience in the medical/regulatory writing field gained in a pharmaceutical/biotech industry environment in positions with increasing levels of responsibility.
Includes proficiency at authoring/editing and managing the writing/review of multiple types of clinical regulatory documents and submissions and extensive knowledge and experience relevant to multiple therapeutic areas disease areas and technical disciplines.
Proven ability to advise and lead communication projects.
Broad cross-functional understanding of the drug development process from scientific technical and business -depth knowledge of the technical and regulatory requirements related to the role.
Extensive knowledge of the latest technical and regulatory documentation expectations desirable.
What We Offer
We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration quality and making a difference in the lives of patients.
Our core values of Trust Quality Passion Flexibility and Sustainability guide our decisions and shape our culture. By aligning on these values we foster collaboration innovation and a shared commitment to excellence. Together we make a difference.
A Bit More About Us
Our journey began over 30 years ago in Sweden in the city of Lund. As a full-service global CRO we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals TFS delivers tailored clinical research services in more than 50 countries offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology Neuroscience Oncology and Ophthalmology.
Key Skills
About Company
TFS HealthScience is a global, mid-sized contract research organization (CRO) partnering with biotechnology and pharmaceutical companies across the full clinical development lifecycle. Our expertise spans full-service clinical development, project-based support, strategic resourcing, ... View more
