Overview
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:
o Clinical study protocols and clinical protocol amendments
o Clinical study reports
o Investigator brochures
o IND submissions and annual reports
o Integrated summary reports (e.g. summaries of efficacy/safety, clinical overviews)
o NDA, BLA, MAA, (e)CTD submissions
o 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. Conduct 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.
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.
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