Medical Writer

at  iTeos Therapeutics

ABOUT ITEOS THERAPEUTICS, INC

iTeos Therapeutics is a publicly-traded (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of patients with cancer by designing and developing next generation immunotherapies.
Based in Gosselies, Belgium and Watertown, MA, iTeos Therapeutics was founded out of the Ludwig Institute for Cancer Research (LICR) and the de Duve Institute (UClouvain) in 2011.
In March 2020, the Company completed a $125 million Series B2 financing, and in July 2020, we completed our IPO, raising over $230 million of gross proceeds. In June 2021, the Company entered into a transformative $2.145 billion co-development and co-commercialization agreement with GSK for EOS-448, the Company’s anti-TIGIT monoclonal antibody. As a well-capitalized biotech company, we are positioned to continue to develop our clinical pipeline and maintain our investments in our discovery research team to leverage our innovative science to improve the lives of patients with cancer.
Our values - Data Driven, Ownership, Courage, and Stronger Together - form the foundation of who we are as a company and define who we are at our core.
For more information, please visit www.iteostherapeutics.com.
iTeos Therapeutics is now a world-class actor in the sector. To carry on its growth and reinforce its team, iTeos Therapeutics is looking for a Medical Writer.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

• Advanced degree preferred (PhD or PharmD) with at least 5+ years’ experience writing and managing regulatory documents in pharmaceutical industry OR Master’s degree in a scientific discipline with 7+ years of experience in a pharmaceutical, biotechnology, contract research company (CRO).
• 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, 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.
• Proficiency in computer skills including Microsoft Office (Word, Excel, PowerPoint, Project, Outlook) and familiarity with SharePoint and Veeva.
• Ability to manage and enact change, identify process improvements, and foster innovation.
• Ability to manage change successfully and 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.
• Expert knowledge of AMA style, medical terminology, clinical data analysis and willingness to adapt working style and work product as required while adhering to quality standards.
• Attention to detail including fact checking, logical flow, parallelism, formatting, document structure and ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Excellent interpersonal and influencing skills; ability to build 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. Not opposed to occasional flexible working hours to get project completed per regulatory timelines.

ROLE: MEDICAL WRITER

iTeos Therapeutics is seeking an innovative, collaborative integrative thinker who will be 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 for organizing and managing the reviews for these documents. This position will report to the Head of Medical Writing. The successful candidate will be an autonomous, proactive, experienced medical writer with experience working in a clinical development environment.

MAIN RESPONSIBILITIES

• Lead and collaborate with cross functional team members in Clinical Development, Clinical Operations, Translational Medicine, Regulatory, Biometrics, Quality and Program Management in planning and authoring of high quality clinical and regulatory documents, including but not limited to parts of the INDs, CA documents, clinical study reports, narratives, protocols and amendments, Informed Consent Forms, investigator’s brochures, DSURs, briefing documents, etc., according to company Standard Operating Procedures (SOPs), European Medicines Association (EMA) and US (FDA) Health Agencies’ guidelines to support drug development under strict timelines. Act as a subject matter expert on internal standards and external regulatory guidelines.
• Manage teams and medical writing projects. Oversee and review work of internal and external medical writers for accuracy, quality, clarity, consistency of scientific content and alignment with company position.
• Ensure key messages are clear and consistent within and across documents. Contribute strategically and scientifically at the project and/or study team level.
• Understand clinical data and use text, tables, and figures as appropriate to accurately and effectively convey key messages.
• Implement document quality controls (QC), standards and best practices Process and Resource Management, assist with quality control and “peer” review of all documents for submissions to Competent Authorities.
• Contribute to the design and maintenance of SOPs, work instructions, style guides and templates for protocols, investigator’s brochures, clinical study reports in accordance with ICH guidelines and medical writing best practices.
• Represent Medical Writing on cross-functional teams.
• Assist in the day-to-day operational activities.