Head of Medical Writing

Il y a 7 mois

Gosselies, Belgique iTeos Therapeutics Temps plein

**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.

**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 Head of Medical Writing.**

**ROLE**:Head of Medical Writing**

**MAIN RESPONSIBILITIES**
- Advise on strategic document development, ensuring adherence to regulations, ICH guidelines, and standard operating procedures (SOPs).
- Develop budget and resource strategies to ensure on schedule completion of medical writing deliverables using a mix of internal and external medical writers.
- Independently author, and manage others in creation of clear and concise submission-ready documents.
- Develop and maintain SOPs, style guides, and quality control checklists that drive consistency across documents and processes.
- Build and mentor medical writing team.
- Represent Medical Writing in Inspection Readiness and participate in GCP Audits and Inspections.
- Plan strategically, anticipate problems, and recommend process improvements to address current and future needs.
- Build and ensure maintenance of knowledge base to improve the overall medical content of documents and ensure adherence to multinational regulatory standards.
- Establish systems and best-practices for training multidisciplinary colleagues participating in document authorship Lead cross-functional process improvement initiatives on document standards, template development, and document processes.
- Working knowledge of US FDA and European regulatory requirements.
- Extensive experience with IND and BLA packages, primary authorship of key components (i.e. CSRs) and mentorship of colleagues contributing to these submissions.
- Collaborate effectively across Clinical, Regulatory, Quality, Biostatistics, Data Management and CMC in a team environment.

**PROFESSIONAL EXPERIENCE/QUALIFICATIONS**
- Advanced degree in life sciences preferred; advance degree preferred; minimum BS/BA required;
- 12+ years’ experience in a medical writing capacity within drug development, ON experience preferred.
- Prior direct experience leading medical writing teams responsible for all phases of drug development
- submission experience highly desired.
- Extensive knowledge of English grammar and American Medical Association style guide.
- Demonstrated experience mentoring medical writers, managing project work of internal medical writers, and supervising external (contract/vendor) writers.
- Well organized; able to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines.
- Working knowledge of biologics drug development, clinical research, study design, biostatistics, regulatory, and medical terminology.
- Proactive team player, collaborative, and flexible.
- Experience leading a team of Medical Writers.
- Ability to operate in a fast-paced, collaborative environment.
- Ability to perform work with a high degree of accuracy and quality while working under tight deadlines.
- Excellent verbal, written, and interpersonal communications skills with the ability to explain complex concepts with clarity and simplicity.

**OFFER**
- A stimulating position within a high-potential innovative biotech company.
- The opportunity to work in a science-driven, dynamic, respectful, and professional environment.
- A challenging scientific and business growth in which you get to bring your knowledge and skills.
- A permanent contract with an attractive salary package in line with the position responsibilities and your experience.

**RECRUITMENT PROCESS

  • Head of Talent Management

    Il y a 7 mois

    Gosselies, Belgique iTeos Therapeutics Temps plein

    **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...

  • Head of Data Science

    il y a 4 jours

    Gosselies, Belgique iTeos Therapeutics Temps plein

    **ABOUT ITEOS THERAPEUTICS SA** iTeos Therapeutics is a publicly held (NASDAQ: ITOS), clinical-stage biopharmaceutical company dedicated to extending and improving the lives of cancer patients by designing and developing next generation immunotherapies. Based in Gosselies, Belgium and Watertown, MA, iTeos Therapeutics was founded out of the Ludwig...

  • Head of Talent Management

    Il y a 7 mois

    Gosselies, Belgique iTeos Therapeutics Temps plein

    **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...

  • Head Qp

    il y a 2 semaines

    Gosselies, Belgique Catalent Temps plein

    **Head QP** As QP Head you will be reporting to Director QA Operations **The Role** - Principal QP for the Catalent Cell Therapy sites (clinical and commercial) at Gosselies, Belgium - Point of contact with the Belgian Ministry of Health (FAMHP) - Head of the Cell Therapy European QP Office, which handles the QP certification of imported batches from...

  • Site Head

    il y a 2 semaines

    Gosselies, Belgique CellCarta Temps plein

    **About CellCarta** **CellCarta** is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development...

  • Head of Project Management

    il y a 6 heures

    Gosselies, Belgique Thermo Fisher Scientific Temps plein

    **How will you make an impact?** Enable our clients to cure genetic, rare, and otherwise untreatable diseases through our leading and groundbreaking Cell and Gene Therapy business by elevation of the program management organization. The Cambridge VVS Program Management Sr Manager is a solution provider to Viral Vector Services (VVS) customers, ensuring...

  • Head of Operational Processes

    Il y a 2 mois

    Gosselies, Belgique Orange Temps plein

    **Mission proposée** Position de Management responsable de la définition, du pilotage et des améliorations des processus opérationnels des équipes Infrastructure. En charge également de la construction et amélioration des cockpits de pilotage Managérial et des reportings de mesure de performance des processus opérationnels pour toute l’activité...

  • Sales Representative

    il y a 2 semaines

    Gosselies, Belgique Quadrature SA Temps plein

    Quadrature S.A., headquartered in Gosselies, Belgium, is a leader in software for the windows and doors industry. Our WinPro Corporate software is an enterprise solution used in the windows and doors industry and by traditional dealers for selling, designing, producing and delivering windows. For our location in Belgium we are looking for a Sales...

  • Research Assistant

    Il y a 7 mois

    Gosselies, Belgique CellCarta Temps plein

    **Research Assistant (evening and weekend rotation) - Immunology / Serology** **Summary** Reporting to the Laboratory Group Leader, the Research Assistant will work as part of a team focused on the characterization of the cellular and humoral immune response. The main responsibilities include flow cytometry, viral neutralization assays and ELISA assays....

  • Director of Commercial Operations Plasmids

    il y a 3 jours

    Gosselies, Belgique Catalent Temps plein

    **Director of Commercial Operations Plasmids** **Remote - Gosselies, Belgium** **Position Summary**: The Director, Commercial Operations will lead the transition of business-related activities for specified products from Business Development post initial contractual commitment. The Director will act as the site representative for business-related topics...

  • Proposal Writer

    il y a 4 jours

    Gosselies, Belgique Catalent Temps plein

    Catalent Cell and Gene Therapy (CGT) hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and...

  • Expert Scientifique

    il y a 5 jours

    Gosselies, Belgique L’IPG Temps plein

    Scientific Expert The** Scientific Expert** will fully integrate the Molecular and Cellular Biology Department and will report to the laboratory supervisor of the Cytogenomics prenatal Unit. The main part of the job consists in establishing prenatal diagnostics. **Main Responsibilities/Tasks** - Interpretation cytogenomics/cytogenetics results -...

  • Quality Assurance Auditor I

    il y a 2 jours

    Gosselies, Belgique CellCarta Temps plein

    **About CellCarta** CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development...

  • Metrology Expert

    il y a 2 semaines

    Gosselies, Belgique Catalent Temps plein

    Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations, and speed up the arrival of their therapies onto the market. From technology selection to business modeling, through GMP manufacturing, process development, quality services, Catalent’s teams are...

  • Gis Functional Analyst

    il y a 4 jours

    Gosselies, Belgique Vector Synergy Temps plein

    **Location**: Gosselies, Belgium **Reference No**: 53357 / Gosselies **Introduction**: One of our clients is currently looking for a GIS Functional Analyst to assume the role of a designer of functional solutions adapted to the needs expressed by business as part of the development and maintenance process. **Duties/role**: - Performing functional...

  • QA Third Party Manager

    il y a 7 jours

    Gosselies, Belgique Catalent Temps plein

    Based in Gosselies, the mission of Catalent Cell and Gene Therapy is to deliver optimized process industrialization capacities to cell therapy organizations and speed up the arrival of their therapies onto the market. From technology selection to business modelling, through GMP manufacturing, process development, quality services, Catalent’s teams are...

  • Financial Planning

    Il y a 7 mois

    Gosselies, Belgique iTeos Therapeutics Temps plein

    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...

  • Financial Planning

    Il y a 7 mois

    Gosselies, Belgique iTeos Therapeutics Temps plein

    **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...

  • Test Analyst

    Il y a 7 mois

    Gosselies, Belgique ATCON GLOBAL Temps plein

    **Location**:Gosselies(2days/week onsite) **Languages**:French(C2), English(B1) **Type of employment**:Freelancer or Employment **Start date**:ASAP **Responsibilities.** **Main tasks** Participate in the various Agile/Scrum ceremonies (daily meeting, retrospectives, grooming, poker sizing, demo,...) Participate in the writing of the US and its acceptance...

  • Team Leader Noc

    Il y a 7 mois

    Gosselies, Belgique VOO Temps plein

    **Présentation du service****: - VOO est active dans le secteur des télécoms, en Wallonie et à Bruxelles, et commercialise des services de : télévision, de connexions internet, de téléphonie fixe et de téléphonie mobile. Les offres de VOO sont aujourd'hui parmi les plus performantes et les plus attractives sur le marché.**5 bonnes raisons de...