For our customer located in Zurich/Switzerland we are currently looking for a: Medical Writer (m/f/d)
Tasks & Responsibilities
- Manages and coordinates regulatory submission document preparation, including coordination of assignments and contract writers, review, and substantive editing of documents.
- Coordinates preparation of documents for submission to FDA or other regulatory agencies, ensuring consistency of content within the assigned submission or project and adherence requirements and processes.
- Manages and coordinates internal and external contributors for assigned regulatory submissions and projects in collaboration with stakeholders.
- Reviews medical writing processes, standards, and templates.
- Takes Project Management role on functional teams that address requirements or issues related to document preparation and production. Plans and coordinates QC activities of all documents within Medical Writings responsibilities.
- Represents Medical Writing on cross-functional teams and task forces (related to projects, process, and standards).
- Acts as a secretariat for monthly meetings with our external MW to remain oversight & other meetings as required.
- Fulfills documentation, document management, document administration and administrative tasks such as meeting planning, travel management etc. as required by assigned team.
- Supports PowerPoint presentations development.
Must Haves
- Advanced degree (PhD, PharmD) in a relevant scientific/clinical/regulatory field preferred; Master’s degree required.
- 1-3 years’ experience in Global Regulatory Medical Writing for pharmaceutical or biotechnology, including electronic documents and submissions.
- Ability, with minimal oversight, to coordinate the development, review, and approval of all clinical regulatory document types.
- Ability to analytically evaluate and interpret clinical and scientific data; ability to define data presentation to meet key messages developed by the clinical and therapeutic teams.
- Strong project management skills including understanding of clinical timelines (study and submission level), working knowledge of the roles of other functional areas and interdependencies among groups; ability to establish detailed timelines for completion of assigned projects and ensure efficient, timely completion.
- Ability to appropriately manage resourcing across multiple projects with competing workload priorities.
- Strong oral and written communication skills, ability to clearly present technical information within and across functional areas.
- Understanding and working knowledge of current global regulatory requirements/guidelines applicable to clinical research and GCP/ICH/eCTD compliant documents.
- Excellent working knowledge of writing-related computer software, templates, and electronic document management systems.
- Understanding of clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
- Ability to understand the guidelines and requirements related to the preparation and production of regulatory documents and submissions.
- Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams and with external providers.
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.