Senior Medical Writer

Keyrus Life Science is looking for a Senior Medical Writer to join their consultancy team for a specific project based in Brussels.
Scroll to content

What we offer

Joining our consulting team means giving your career a step forward. Thanks to the privileged partnership we have with our well-established clients, leaders in their domain, we offer our consultants unique projects to develop their skills, and put their professional experience in the pharma industry on the fast track.

As an expert on the client side, you can count on us to support you at each step of your project thanks to regular touch points with our Key Account Manager. We then also carefully choose with you what would be your next assignment that is matching your career goal whether it is in Consulting or in one of our Functional Services Platforms.

We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.

Job Description

Keyrus Life Science is looking for a Senior Medical Writer to join their consultancy team, for a specific project based in Brussels. 

Your challenges will be : 

  • Write and prepare submissions documents within a team environment.
  • Ensure critical review and interpretation of efficacy and safety data for appropriate medically relevant and Standard Operating Procedures (SOP)/Good Clinical Practices (GCP)/International Conference on Harmonisation (ICH) compliant presentation.
  • Manage the review and approval process of submissions documents; notify team of targeted review responsibilities. Generate consensus among reviewers, resolve conflicting comments, and facilitate discussions in an efficient manner.
  • Review and comment on documents in program (eg, protocols and statistical analysis plans) associated with project assignments.
  • Act as Program Medical Writer (as assigned). Provide process, content, and planning expertise to Team, Satellite Team, and Submission Team regarding document preparation, submission strategy and consistent scientific messaging. Advise team on Medical Writing resource utilization, efficiencies, timelines, and inter-dependencies. Oversee preparation of submission documents for a program; review and provide feedback on submission documents to maintain consistent content, messaging, and style. 
  • Coordinate with other Program Medical Writers and other Medical Writers as needed to maintain consistency across documents within a project and across indications.
  • Participate in the development of processes and tools related to authoring and reviewing of documents. Continually share best practices in an effort to create higher quality documents more efficiently. 
  • Maintain and demonstrate comprehensive knowledge of drug process and applicable regulatory guidelines. 
  • Maintain and demonstrate knowledge of company- and project-specific guidelines for the generation of submissions documents, including SOPs, templates, and document writing conventions and styles. 
  • Liaise with vendors/external contractors as assigned. Ensure timelines and quality of product when the writing of a document is outsourced. Such other responsibilities and projects as the company may assign.
  • Synthesize literature review findings into reports in various therapeutic area.

Profile

  • You have a degree or a Phd in Science with at least 3 years of experience as a Medical Writer in a Contract Research Organisation (CRO), pharmaceutical, and/or biotechnology environment. 
  • You are Fluent in English (spoken and written) and have a good knowledge of ICH-GCP guidelines. 
  • You have a good understanding of the significance of clinical, epidemiological and scientific data in general, and the drug process and applicable regulatory guidelines. 
  • You are detail-oriented with a strong analytical and organisational mindset. 
  • You understand the consultancy model, and represent Keyrus Life Science at the client's site.

Who we are

Keyrus Life Science is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better

From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.

Additional information

  • Remote status

    Flexible remote

We usually respond within a week

Or, know someone who would be a perfect fit? Let them know!

Waterloo, Belgium

Drève Richelle 161
1410 Waterloo Directions

Our offices are the place where you are always welcome when you are not working on client's site or from home. Every single person that joins us is met in a personal and unique way.

What is really common to all of us, is the envy to contribute to the improvement of people’s health. Every employee being part of Keyrus Life Science is therefore fully committed to making the world a better place to live.   

With us, you will be part of our family and feel our human approach culture as of Day 1! 

Already working at Keyrus Life Science Belgium?

Let’s recruit together and find your next colleague.

Teamtailor

Applicant tracking system by Teamtailor