Medical Writer
Ctc Clinical Trial Consultants AB / Biomedicinjobb / Uppsala
2024-09-30
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hela Sverige Join CTC - where ambition is high and one of the goals is to strengthen the Swedish infrastructure in the Life Sciences! We are growing and are now looking for an additional Medical Writer who wants to contribute to CTC's continued journey. Are you an experienced Medical Writer (MW) who wants to use your expertise to drive CTC's development? Then this is the opportunity for you!
As a Medical Writer at CTC, you will be part of a team of four other MWs responsible for writing and quality-checking regulatory documents, primarily clinical study protocols and reports. The work alternates between individual tasks and teamwork. You will be part of various study-specific project teams responsible for initiating and managing clinical projects until the delivery of study results. These project teams include various professionals such as project managers, medical and scientific advisors, research nurses, doctors, statisticians, and more.
Main responsibilities:
To write clinical study protocols and clinical study reports in accordance with ICH E6, ICH E3, and/or ISO 14155, and coordinate the development process of these documents, both internally and with our clients.
To write other regulatory documents and texts such as summary of results, narratives, substantial amendments and responses to authorities.
Quality control of the above-mentioned documents.
To contribute to the continuous development of the organization's processes and templates in accordance with ICH-GCP and/or ISO 14155 and other applicable regulations and guidelines.
To collaborate with other departments within CTC on cross-functional process development.
To coordinate and lead meetings, both internally and externally, and act as a point of contact for clients.
To participate in inspections and audits as needed.
To serve as a mentor to colleagues.
Other tasks such as medical coding, writing abstracts and scientific articles, writing assignments related to safety reporting, and writing marketing documents may also be required.
We are looking for a driven and experienced Medical Writer who truly enjoys writing and formulating scientific texts. To succeed in this role, you need to have the ability to quickly and efficiently interpret, summarize, and present large amounts of data. We require you to have at least 3 years of experience in medical writing, drug development, and clinical trials. Previous experience in consultancy work and an understanding of the customer perspective are also valued. As a person, you are communicative and enjoy collaborating with experts in various fields. You are flexible, works independently, and deliver within agreed timelines. CTC's core values: Innovation, Community, Respect, Commitment, and Professionalism resonate with you.
At CTC, you will be covered by a collective agreement and offered benefits such as flexible working hours, wellness allowance, and generous vacation terms. You will have the opportunity to work in a knowledge-intensive environment in a company with short decision-making paths, with good professional development opportunities.
The position is located at our office in Uppsala (hybrid work is possible). Full time (40 hours per week).
If you have questions, contact Marit Wangheim (Group manager Medical Writing)
marit.wangheim@ctc-ab.se Publiceringsdatum2024-09-30KvalifikationerMSc in the life sciences field.
At least 3 years of experience in medical writing, drug development, and clinical trials.
Experience in leading meetings and coordinating complex and parallel deliveries within agreed timelines.
Proficiency in using the Microsoft Office suite, especially Microsoft Word.
Excellent ability to express yourself grammatically correctly and clearly in English, both spoken and written.
Meriterande
A PhD in the life sciences field.
Good knowledge of the Swedish language (spoken and written).
Experience with Phase 2-3 trials.
Experience with medical devices and/or advanced therapy medicinal products (ATMP), as well as knowledge of regulatory requirements related to these areas.
Experience in writing eCTD module 2; Clinical and Non-Clinical overview/summary, Investigator's Brochures (IBs), Annual Safety Reports (ASRs).
Så ansöker du Sista dag att ansöka är 2024-10-06
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Ctc Clinical Trial Consultants AB (org.nr 556849-1848)
Dag Hammarskjöldsväg 13 (
visa karta)
752 37 UPPSALA
Arbetsplats CTC Uppsala
Jobbnummer 8928132