The role requires strong expertise in CMC for biologicals (initial submissions and lifecycle maintenance), preparing CMC sections of IND/IMPDs, BLA/NDA/MAAs and post-approval variations, knowledge of ICH/EU/US regulations, experience with change management and document management systems (e.g., Veeva). A university degree in a pharmaceutical-related discipline and 10+ years' industry experience are required; fluent English is required.

Join Parexel's Proposals and Contracts team as a Strategic Proposal Writer to lead proposal development from strategy through delivery. The role involves collaborating with proposal managers, sales leaders and cross-functional teams to produce differentiated, client-focused proposals and contracts, conducting market and therapeutic-area research, maintaining proposal templates, and mentoring junior staff. Experience in CRO proposals, FSP/FSO models, and strong proficiency in Microsoft Office and proposal-related tools is required.

Parexel seeks a Senior Medical Writer to develop, coordinate, review, and finalize clinical and regulatory documents (e.g., clinical trial reports, protocols, Investigator's Brochures, biomarker reports) and manage document lifecycles within EDMS. The role involves driving review cycles, quality control, publishing activities, stakeholder coordination, and supporting submission-related documentation. Locations listed include Hungary, the United Kingdom, and the Netherlands (remote options noted).

Parexel seeks a Medical Writer II / Senior Medical Writer to develop and finalize clinical and regulatory documents (CTRs, CTPs, IBs, protocol amendments, biomarker reports, submission documents), manage documents in EDMS, coordinate review cycles, perform quality control, and support publishing and approval processes. Role is remote for Spain and Poland; minimum one year of medical writing experience required.

Parexel seeks a Senior Medical Writer to author and review clinical and regulatory documents (protocols, CSRs, IBs, ICFs, clinical overviews/summaries, safety reports, CTD documents). The role requires ensuring compliance with ICH-GCP, FDA and EMA guidelines, coordinating cross-functional reviews, reviewing statistical outputs, performing quality checks, and mentoring junior writers. Candidates should hold a relevant degree (BSc/MSc/PharmD/MD/PhD or equivalent) and have medical writing experience in a CRO, pharmaceutical, or biotechnology environment; proficiency in MS Word/Excel and document management/collaborative authoring tools is required.

Parexel is hiring a Senior Medical Writer (UK or Ireland, remote) to deliver and manage clinical documents for a functional service provider program. Responsibilities include drafting CTRs, CTPs, IBs and updates, managing EDMS and review cycles, conducting QC and publishing support. Requires a scientific degree, strong communication and 5 years' medical writing experience with knowledge of ICH GCP and clinical trial processes.

Parexel seeks a Senior Medical Writer to join a sponsor-dedicated team working remotely in Italy. Responsibilities include drafting and finalizing clinical documents (CTRs, CTPs, IBs, amendments, biomarker and submission materials), EDMS document management, SAP review, QC reviews, timeline management, and meeting preparation. Requires a scientific degree, strong communication and collaboration skills, and at least 5 years' medical writing experience with knowledge of ICH GCP and regulatory/clinical trial processes.

Senior leadership role responsible for driving AI adoption and integration across the enterprise by translating technical AI and generative AI concepts for non-technical audiences, partnering with change management, learning and development, and corporate communications, and leading a team that curates education programming and strategic communications. Requires 10+ years of relevant experience and a bachelor’s degree.

Responsible for creating placeholders, uploading MLR content and reference documents, linking and anchoring assets, initiating and monitoring QC workflows in Veeva Vault PromoMats/Medical, and coordinating with internal and external stakeholders to ensure asset quality. Role prefers candidates with scientific/medical or data analysis background and prior Veeva or pharmaceutical content review experience.