iTeos Therapeutics is searching for a creative, resourceful, integrative thinker that is responsible for planning and authoring clinical and regulatory documents (for example, clinical study protocols and reports, investigator’s brochures, clinical trial applications, periodic annual reports, etc.) according to company guidelines and international governmental regulations. The Medical Writer is responsible for presenting clinical data objectively in a clear, concise format, and also for organizing and managing the reviews for these documents. This position will function under the guidance and direction of the medical director. The successful candidate will be an autonomous, proactive, experienced medical writer with experience working in a clinical development environment.
- Work with colleagues from various functional areas in Clinical Development, Clinical Operations, Translational Medicine and Program Management in planning and authoring of high quality clinical and regulatory documents, including clinical study protocols and reports, investigator’s brochures, etc., according to company and European (EMEA) and US (FDA) Health Agencies’ guidelines in order to support drug development under strict timelines.
- Work effectively with CROs to ensure efficient editing and publishing of documents and dossiers.
- Function as an integral part of the clinical team which includes external vendors.
- Ensure a consistent style of presentation of documents to maintain quality and ease of review.
- Perform quality control (QC) review of all documents produced by the Team that will be part of submissions to Competent Authorities.
- Keep stakeholders informed on document progress and other project related information.
- Contribute to the design and maintenance of templates/standards for protocols/reports in accordance
- with ICH guidelines and medical writing best practices.
- Represent Medical Writing on cross-functional teams.
- Collaborate with and support the department leadership to ensure continuous improvement, and high standards for quality and productiveness.
- Must be available to dedicate at least 24 hours per week to work at iTeos. Remote work may be considered once a strong working relationship has been established with the Belgian team.
- Experience (3+ years) as a medical writer, or equivalent, and presenting relevant specialist qualifications; Bachelor’s degree in a clinical, scientific, or industry-related discipline is required; advanced scientific, pharmacy or medical degree is preferred.
- Possesses strong written and verbal communication skills and the ability to clearly, accurately and concisely prepare all types of clinical documentation, including complex documents, in English.
- Working knowledge of ICH and EU and US regulatory requirements is required, including knowledge of the requirements for preparation of key clinical and regulatory documents.
- Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology; experience with early stage or Oncology drug development is preferred.
- Documented excellence in advanced features of Microsoft Word.
- Experience with the design and maintenance of templates/standards for protocols/reports; experience with the design and set-up of document management system is preferred.
- Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
- Demonstrated problem-solving ability, sense of urgency, and ability to prioritize tasks, to work simultaneously on multiple projects, and to independently complete high-quality documents according to tight timelines.
- Attention to detail and ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
- Excellent interpersonal skills, ability to develop good relationships with key stakeholders, good conflict management and negotiation skills. Able to work both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment.
- Experience in successfully resolving conflicting editorial opinions expressed by team members
- Strong team player who has a customer service approach and is solution oriented.
- Resourceful, energetic, self-starter
- Approaches challenges with creativity and pragmatism
- Ability to engage team to achieve goals without direct authority
For our recruitments in Belgium, we closely collaborate with a Recruitment & Selection company, PaHRtners. Your application will be automatically forwarded to them. We, together with PaHRtners, will keep all your data confidential (GDPR compliant approach ).