Job Description

Keyrus Life Science is looking for a Senior Medical Writing specialist to help us on a mission based in Brussels. 

Your challenges will be : 

• Write and prepare clinical submissions documents within a team environment.
  
• Ensure critical review and interpretation of clinical efficacy and safety data for
  appropriate medically relevant and Standard Operating Procedure (SOP)/Good Clinical Practices (GCP)/International Conference on Harmonisation (ICH) compliant
  presentation.
• Manage the review and approval process of clinical 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 clinical program (eg, protocols and statistical analysis plans) associated with project assignments.
• Act as Clinical Program Medical Writer (as assigned). Provide process, content, and planning expertise to Clinical Trial Team, Clinical Satellite Team, and Submission Team regarding document preparation, submission strategy and consistent scientific messaging. Advise team on Medical Writing resource utilization, efficiencies, timelines, and interdependencies. Oversee preparation of clinical submission documents for a program; review and provide feedback on clinical submission documents to maintain consistent content, messaging, and style.
• Coordinate with other Clinical 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 clinical documents. Continually share best practices in an effort to create higher quality documents more efficiently.
• Maintain and demonstrate comprehensive knowledge of drug development process and applicable regulatory guidelines.
• Maintain and demonstrate knowledge of company- and project-specific guidelines for the generation of clinical 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.

Profile

• You have a Bachelor's degree or a Master's Degree in Science with at least 5 or more years experience in medical writing in the Biopharmaceutical industry. 
• You are Fluent in English (spoken and written).
• You have a good understanding of the significance of clinical, epidemiological and scientific data in general. 
• You have the ability to work under stress and without close supervision. 
• You have a high degree of familiarity with statistical and data output.
• You have strong computer skills ; proficiency in MS Word. 
• You are detail-oriented with strong a analytical and organisational mindset.
• Having a certification in AMWA, EMWA, RAPS, etc. is a plus.

What we offer

At Keyrus, thanks to the expertise of our people and external partners, each employee is welcomed with a varied integration program. You will join a dynamic and international environment with enthusiastic and professional colleagues.

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.

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 skilfully, 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.