Offre d'emploi : Medical Writer
iTeos Therapeutics is a privately-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 Cambridge, 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 $230million of gross proceeds. In June 2021, iTeos entered into a transformative $2.145 billion co-development and co-commercialization agreement with GSK for EOS-448, iTeos’s anti-TIGITmonoclonal antibody. As a well-capitalized biotech company iTeos is positioned to continue to develop our clinical pipeline and maintain our investments in our discovery research team to leverage our fantastic science to improve the lives of cancer patients.
For more information, please visit www.iteostherapeutics.com.
iTeos Therapeutics is now a world-class biotech in cancer immunotherapy. To carry on its growth, expand its pipeline and reinforce its team, iTeos Therapeutics is looking for a (m/f) Medical Writer.
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 for organizing and managing the reviews for these documents. This position will function under the guidance and direction of the Head of Medical Writing and report into the VP of Clinical Operations. 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, Regulatory and Program Management in planning and authoring of high quality clinical and regulatory documents, including parts of the INDs, CA documents, 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 ICFs, 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 some time per month to work onsite iTeos per COVID country guidelines, otherwise all other time is remote.
- Experience (5+ 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. Not opposed to occasional flexible working hours to get project completed per regulatory timelines.
- Resourceful, energetic, self-starter
- Approaches challenges with creativity and pragmatism
- Ability to engage team to achieve goals without direct authority
- Able to work in highly matrixed environment, with multiple stakeholder and a fast past environment.
- 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.
- An employment agreement contract with an attractive salary package in line with the position responsibilities and your experience
Send your CV together with an adapted cover letter via https://www.pahrtners.be/en/jobs/medical-writer-mf-en/ or to the following address: firstname.lastname@example.org.
Your application and related information will remain strictly confidential.