Medical Writer

Job Purpose

We are looking for a Medical Writer that supports the company across the full life cycle of drug development, interacting with project teams to support the creation and development of clinical study documentation as well as other dossier related documentation. As medical writer, the role is required to support the medical writing team and to interact with cross-functional project teams, ensuring adherence to project plans, applicable regulatory, GCP and SOP requirements and company policies and procedures. 
Role works in close collaboration with Clinical Operation and Development Teams, for both SPC & Rare Diseases BUs, Medical Affairs, Regulatory Affairs, Quality Assurance, Portfolio Management and other functions, as appropriate.

Key Responsibilities

•    Support the Senior medical writing manager  and the team in the preparation, editing and compilation of various clinical documents for regulatory submission during all phases of clinical drug development and post‐marketing studies. 
o    Clinical Study documentation: independent preparation of Patient Safety Narratives, Patient Lay Summaries, patient consent forms, dossier related documentation (such as Clinical summaries, Briefing Books, PDCO submissions), with support from other functions. Support the senior MW in the Clinical Study Protocol and Reports and IB preparation across a variety of therapeutic areas. 
•    Perform the quality control (QC) review of clinical study documentation if requested by supervisor.
•    Tabulation of clinical studies results
•    Perform on-line clinical literature search, as requested. Maintains familiarity with current industry practices and regulatory requirements and guidelines. Ensure controlled and accurate use of medical and scientific terminology. 
•    Support in redaction of clinical documents in accordance with EU Clinical Trial Regulation, EMA Policy 0070 and other global regulations
•    Responsible for the compilation and publication of trial data in relevant registries with support from relevant Medical Director
•    Participation in cross‐functional global team meetings
o    Collaborate with Study Managers, Project Leaders, Clinical trial Application Manager, Regulatory development lead, Biostatistics, Patent and Legal, to ensure awareness of data sharing requests and proper safeguarding of the data in collaboration with the company DPO, where applicable.
•    Collaborate with Clinical Operations, Global Project Teams, and other stakeholders to operationalize and develop novel processes related to redaction requirements.
•    Interact with Project Teams irrespective of global location

Required Education

Bachelor's degree in a relevant scientific field (e.g. life Science, Pharmacy). Advanced degree (Master’s , PhD., or equivalent) is preferred

Required Skills and Experience

•    5+ years’ experience as a Medical Writer in the CRO/pharmaceutical industry
•    Strong portfolio demonstrating a track record of creating clear, concise, and scientifically accurate documents, such as clinical study reports, regulatory submissions, and scientific publications.
•    Familiarity with various therapeutic areas and drug development processes.
•    Excellent writing and editing skills, with a keen eye for details and the ability to interpret complex scientific and clinical data and present it clearly. Proficient in creating a variety of documents (clinical protocols, clinical reports, investigator brochures, and regulatory documents).
•    Regulatory knowledge: Understanding of regulatory guidelines and requirements related to clinical research and drug development (e.g., ICH guidelines).
•    Experience with preparing documents for regulatory submissions (e.g., INDs, NDAs, MAAs) is highly desirable.

Technical Competencies

Experience in training and familiar with traditional and modern training processes. Proficient in using relevant software and tools for document preparation and collaboration (e.g., Microsoft Office, GraphPad Prism, Safety databases, document management systems like Veeva).

Required Behaviours and Competencies

•    Excellent communication skills, both written and verbal, to interact within a cross-functional team and external experts
•    Experience anticipating and resolving problems on projects
•    Experience in reporting project details to various stakeholders within and outside of the company
•    Ability to adapt to evolving project requirements, guidelines and industry standards. Commitment to continuous professional development, to stay updated on the latest development in scientific research.

Required Languages

Fluent in English (written and spoken)