Medical Writer (IT)
On behalf of our Pharmaceutical client based in Zurich, we are looking for a Medical Writer for a short term contract of 5 months with the possibilty of extension.
- Start date; 24.04.2023
- End date: 29.09.2023
- Location: Zurich
The Medical Writing (MW) Junior Manager is responsible for providing support to plan and resource the MW deliverables that support business objectives for clinical development for VBU with multiple compounds through all phases of development.
The MW Junior Manager can be a dedicated resource to a submission or project, reporting to the Medical Writing Head and supporting the MW team who is responsible for all global vaccine projects.
The activities of the MW Junior Manager (performed with minimal oversight) include, but are not limited to: writing, development of timelines, project management of deliverables, and participation on project teams.
In addition to program responsibilities, the MW Junior Manager may participate in departmental or cross-functional initiatives designed to establish highly efficient processes, best practices, and productive cross-functional collaboration.
* Manages and coordinates regulatory submission document preparation, including coordination of assignments to 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 to 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.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
* 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 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.
Interested in this opportunity? Kindly send us your CV today through the link in the advert. However, should you have any questions please contact Elaine Kanwar at +41 61 282 22 23