Medical Writer

LS Jobbet AB; Uppsala kommun; Hybrid; SEK 520,000 - 760,000; Full time

Benefits offered by this job

Flexible working hours

Wellness allowance

Generous vacation terms

Job summary

CTC Clinical Trial Consultants AB in Uppsala is seeking an experienced Medical Writer to join a team responsible for writing and quality-checking regulatory documents, primarily clinical study protocols and reports, in line with ICH and ISO standards.

You will work within cross-functional project teams, coordinate development and quality control, and mentor colleagues while ensuring timely delivery of study results.

Qualifications

• Must have 3+ years of experience in medical writing, drug development, and clinical trials.
• Experience writing regulatory documents and eCTD modules.
• Excellent command of English; Swedish language knowledge beneficial.

Responsibilities

• Write clinical study protocols and clinical study reports in accordance with ICH E6, ICH E3, and ISO 14155, coordinating development and quality control.
• Write other regulatory texts such as summaries, amendments and responses to authorities.
• Coordinate and lead meetings with clients and project teams; act as a point of contact for clients.
• Mentor colleagues and support knowledge transfer within the MW team.

Skills

Medical Writing

Regulatory Documents

English Proficiency

Communication Skills

Project Coordination

Education

MSc Life Sciences

PhD Life Sciences

Tools

Microsoft Word

Job description

Arbetsgivare CTC Clinical Trial Consultants AB

Medical Writer

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 cross-functional project teams include 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 and quality control processes 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.
• To coordinate and lead meetings, both internally and externally, and act as a point of contact for clients.
• 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).

Krav

• MSc 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.
• Good knowledge of the Swedish language (spoken and written).
• A PhD in the life sciences field.
• 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).