About Prilenia
Prilenia Therapeutics, a clinical-stage biotech company focused on the urgent mission of developing novel therapeutics to slow the progression of neurodegenerative diseases and neurodevelopmental disorders, is looking for a Principal/Senior Medical Writer to join its team in the EU/IL.
We are a flexible, fast-moving team that is quickly advancing a potential therapy poised to have major impact on the lives of patients and their families. Our lead product candidate, pridopidine, holds Orphan Drug Designation in both Huntington’s disease (HD) and Amyotrophic lateral Sclerosis Amyotrophic (ALS) in the US and EU, as well as Fast Track designation from the FDA for the treatment of HD. Prilenia is working on preparing for regulatory filing for HD in European Union and for starting a global phase 3 study in ALS with pridopidine.
Pridopidine has the potential to be the first treatment to address HD disease clinical progression. Prilenia also believes pridopidine’s novel mechanism of action as a sigma-1 receptor agonist provides it with potential as a treatment of numerous other neurological diseases.
About the role
We seek a highly qualified and experienced professional to join our team as Medical Writer. The Medical Writer works closely with cross-functional project teams to manage preparation of the written deliverables that support the clinical development and regulatory requirements of a clinical program. You are responsible for the planning, writing, reviewing, editing, formatting, and finalization of a/o investigator brochures, clinical synopses and protocols, clinical study reports, investigator brochures, and regulatory submission documents (e.g., INDs, briefing documents, clinical plans and CTD summaries, integrated analysis summaries). You may also assist in the development of scientific posters, abstracts, journal manuscripts, etc. as needed.
The Medical Writer is expected to develop and maintain a network of internal relationships with global and local cross-functional study teams, including personnel from Clinical Development, Medical and Scientific Affairs, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs, Global Safety, Data Management and Non-clinical Development. The position will initially report to our Vice President, Head of Regulatory.
Roles and Responsibilities:Participate and supervise the development of clinical, regulatory, and scientific documents for publication and submission to regulatory agencies and ethics committees as well as be responsible for coordinating the contributions of the different functions involved.Summarize data from statistical tables and other sources as needed.Responsible for the maintenance and tracking of the versions of these documents during development and approval process.Ensure that all sections of these documents are complete and comply with the applicable guidelines & regulations and documents are reviewed and approved by designated personnel.Responsible for maintaining an electronic copy of each approved document.Summarize and incorporate preclinical and clinical data, together with data from literature-based supportive manuscripts, to generate study outlines, synopses and protocols.Authors, edits, and provides QC review of documents to support clinical trials and regulatory submissions, which may include (but are not limited to): clinical study protocols and protocol amendments, clinical study reports (CSR), investigator brochures (IB), informed consent and assent forms, lay summaries of clinical trial results, clinical evaluation plans (CEP), and clinical evaluation reports (CER), annual reports Interprets and accurately presents clinical and statistical data in a clear, concise format.Can identify and resolve problems related to Medical Writing projects, processes, or tasks, with management support as needed.Maintains up-to-date knowledge and understanding of the laws, regulations, industry standards, and company policies/procedures relevant to Medical Writing.Develops project plans for delivering assigned documents and tracks progress toward deliverables and objectives.Qualifications:BA/BS in a scientific, medical or statistical discipline is required; MA/MS or PhD in a scientific, medical or statistical discipline preferred.Five years’ experience writing scientific, clinical, regulatory or medical articles, at least two years’ experience in a CRO or pharmaceutical company environment preferred; an understanding of medical terminology and statistical methods; strong computer skills including word processing and presentation software. More than five years of relevant Medical Writing experience, with a minimum of three years clinical/regulatory medical writing experience in a pharmaceutical, biotechnology, or CRO environment Experience in preparation of clinical/regulatory documents (e.g., clinical protocols, IBs, CSRs, INDs, NDAs/MAAs) Medical Writer versus Senior Medical Writer designation will be determined by the experience level of the candidateMust be knowledgeable of regulatory reporting guidelines and Good Clinical PracticesSkills:Ability to work independently and as a team memberPassionate about high quality medical writing. Highly effective verbal and written communication and interpersonal skills Proficient in Medical Terminology and medical writing skills.Demonstrated understanding of clinical research principles and the drug development process.Able to interpret statistical analysis of clinical trial dataHigh attention to detail to ensure the accuracy and consistency of clinical trial documents. Strong foundation in scientific knowledge to understand and interpret clinical trial data and scientific literature. Able to collaborate with subject matter experts across different time zones and ensure efficient communication and coordination with team members worldwide. This role requires adaptability and strong project/program organizational skills to effectively manage projects and meet deadlines across various geographical locations. Location/Time Zones:
This is a full-time, remote position based in the EU or Israel with occasional in-person/face-to-face meetings. Other global locations may be considered. Flexible schedule with interactions across Israel, North America and Europe time zones. Domestic and International travel may be required.
