Senior Medical Writer (Clinical and Regulatory Medical Writing)
Location: United Kingdom (remote)
Reports to Head of Medical Writing
Opportunity
As a Sr Medical Writer, you will be responsible for planning, writing, reviewing, editing, formatting, and finalising critical clinical documents such as study reports, protocols, investigator brochures, package inserts, and regulatory submissions. You will ensure that all documents adhere to regulatory standards and accurately reflect the scientific data, supporting our clinical development programs by providing clear and concise communication of scientific information.
If you are a skilled Medical Writer with a passion for scientific communication, we encourage you to apply!
Responsibilities
- Coordinate, author and edit documents used to support clinical trial conduct and reporting including but not limited to:
- Clinical study protocols and clinical protocol amendments
- Clinical study reports
- Investigator brochures
- IND submissions and annual reports
- Integrated summary reports (e.g. summaries of efficacy/safety, clinical overviews)
- NDA, BLA, MAA, (e)CTD submissions
- Health Authority responses
- Participate in relevant document subteam(s) and ensure effective planning and management of timelines for all components of assigned documents across all projects/MWs.
- Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects.
- Maintain document prototypes and shells, proactively support developing and reviewing standard processes and templates.
- Comply with internal and external processes and guidelines while managing the review process and, on an ongoing basis, resolve issues, errors, or inconsistencies with pertinent team members to ensure timely completion and high quality of assigned documents.
- Review and edit documents as required. Conducts literature reviews, as needed.
- Work effectively and lead cross-functional document working groups.
- Prepare clinical trial disclosures and registration datasets for ClinicalTrials.gov, EudraCT, and CTIS (Clinical Trial Information System) and gain internal/registry approvals; and populate data within websites for public release.
Skills/Knowledge
Qualifications
- Fluent in English with proven ability to write complex scientific documents effectively.
- Minimum of a Bachelor's degree in biological or clinical sciences; Graduate degree (Master's, PhD, PharmD, or MD) preferred.
- 5-10+ years of relevant experience in regulatory medical writing.
- Demonstrated ability to review, summarise, and present study data in clinical and regulatory documents.
Drug Development Knowledge
- Thorough understanding of the oncology drug development process, from pre-IND through post-registration.
- Understanding of preclinical, regulatory, pharmacovigilance, drug supply, data sciences, and clinical operations in oncology.
Clinical Information and Strategy:
- Ability to apply knowledge of literature reviews, competitive intelligence, and changing treatment paradigms to support a robust clinical development strategy.
- Ability to interpret, analyse, and present oncology clinical data to inform decision-making and set clinical strategy.
- Understanding of trial design and statistics to apply knowledge to the design of clinical protocols.
Technical Skills and Competencies:
- Hands-on experience performing systematic literature searches, summarising results, and presenting conclusions to various audiences.
- Excellent command of Microsoft Word and authoring documents in an online environment (e.g., MS SharePoint).
- Ability to work effectively in a collaborative team environment, incorporating multiple perspectives.
- Strong organisation, documentation, and communication skills with the ability to multitask.
- Flexibility and ability to adjust to changing demands and priorities, meeting challenges with professionalism.
- Detailed knowledge of GCP, ICH Guidelines, and current global drug regulations.
Menarini Stemline is an equal-opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees
The Company
Founded in 1886 in Naples under the name of Farmacia Internazionale, Menarini moved in 1915 to Florence where the Group’s headquarters are still located today. High quality therapeutics and diagnostics solutions for patients, ethics as our underlying principle, dedication to innovation and advancement, strong people centricity and environmental sustainability. These five pillars form the foundation of the Menarini Group, an Italian pharmaceutical company with nearly 135 years of history.
The Menarini Group is present in 70 countries and our products are sold in 140 locations around the world. Its companies span from Europe to Asia, to Africa and the Middle East, to Central America and to the United States where with the acquisition of Stemline Therapeutics, a NASDAQ-listed biopharmaceutical company, the company marked its entry into the US oncology market.
Thanks to the valuable contribution of around 18,000 employees, every year more than 500 million packs of drugs are produced at the Group's 18 manufacturing sites including a biotech plant for the manufacturing of monoclonal antibodies that also serves external clients distributed across 6 continents.
Menarini has made a strong commitment to oncology, investing in a pipeline of five investigational compounds for the treatment of a variety of haematological and solid tumours. The acquisition of Stemline Therapeutics in June 2020, further strengthened Menarini’s oncology portfolio, adding both commercial and clinical-stage assets. Tagraxofusp is a novel, first in class targeted therapy for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) and to date, the only approved treatment for BPDCN in the U.S. and EU, and the first and only approved CD123-targeted therapy. Tagraxofusp is also being evaluated as both a single agent and in combination, in other CD123+ indications, including acute myeloid leukaemia (AML), chronic myelomonocytic leukaemia (CMML), and myelofibrosis (MF).
Additionally, Menarini received exclusive rights to commercialise Selinexor for the treatment of oncology indications in the European Union and other European countries (including the United Kingdom), Latin America and other key countries. Menarini has signed an exclusive licensing agreement with Karyopharm Therapeutics for the rights to commercialise an innovative therapeutic option in Europe, Latin America, Turkey, Russia, and CIS countries. Selinexor is a first-in-class, oral Selective Inhibitor of Nuclear export compound for the treatment of hematologic cancers and solid tumours. It is already marketed in the US for multiple myeloma and is under development for solid tumour indications. Selinexor is registered in the EU for both early and late lines.
Menarini entered into a global licence agreement with Radius Health to complete the development of Elacestrant, an oral SERD in late-stage Phase 3 development for hormone receptor-positive advanced breast cancer. Following a successful phase 3 study, Menarini Stemline received FDA approval in January 2023 under priority review and successfully oversaw a strong launch in February to the US market with the EMA review process concluded positively in September 2023.
Menarini’s commitment to oncology is also reflected in the investments made in the liquid biopsy diagnostic field through its affiliate Menarini Silicon Biosystems (MSB), a pioneer in rare cell analysis and non-invasive, advanced diagnostic solutions. MSB’s CELLSEARCH Circulating Tumour Cell (CTC) Test is the first and only clinically validated blood test cleared by the U.S. Food & Drug Administration (FDA) for detecting and counting CTCs in metastatic breast, prostate, and colorectal cancer when used in conjunction with other clinical monitoring methods.
Since 2021, MSB has offered in the US a menu of non-invasive Laboratory Developed Tests (LDTs) provided through its CLIA/CAP accredited US-based Lab. The services include CMC enumeration, CTC enumeration and PDL-1/HER2 biomarker and offer a minimally invasive approach to follow cancer patient’s therapeutic journey.
In 2022, the company launched the CELLSEARCH® Circulating Multiple Myeloma Cell (CMMC) Enumeration LDT, the first-of-its-kind, which directly measures levels of plasma cells in the blood of patients. This test provides new, complementary information to that of the bone marrow biopsy and other standard-of-care measures. Due to its minimally invasive nature, it can be performed serially to assess plasma cell burden without requiring repeated bone marrow biopsies.
Menarini's vision and uniqueness in oncology is to bring together innovative therapeutic solutions and advanced liquid biopsy-based diagnostics for faster, more effective and precise patient management.
It is an exciting time in the company’s development and an excellent opportunity for individuals joining us to contribute to building and shaping Menarini Stemline’s Oncology business.
