Biotecnologia jobs in Spain

Direct message the job poster from Apsida Life Science

Job Title: Medical Writer (Regulatory) – Project Lead

Location: Remote / Hybrid

Our client is a specialized regulatory affairs consultancy supporting pharmaceutical and biotech companies with strategic advice, regulatory submissions, and document development across the product lifecycle. We pride ourselves on delivering high-quality, agile, and scientifically robust solutions tailored to the needs of small and emerging life‑science organizations.

We are seeking an experienced Medical Writer to lead a major client project focused on the development of regulatory documentation, including briefing books for scientific advice meetings, Risk Management Plans (RMPs), and CTD Modules 2–5 for marketing authorization and clinical trial applications. The ideal candidate will have strong scientific writing capability, deep familiarity with EU and international regulatory requirements, and demonstrated experience coordinating complex document packages across cross‑functional teams.

• Lead the end‑to‑end development of briefing books for EMA/NCA scientific advice and other regulatory interactions, including content planning, drafting, review coordination, and submission preparation.
• Author, edit, and finalize RMPs in alignment with GVP Module V, EMA templates, and product‑specific safety profiles.
• Prepare CTD Modules 2–5, including summaries, nonclinical and clinical overviews, clinical study report components, and associated supporting documentation for regulatory dossiers.
• Drive project timelines, deliverables, and communication, acting as the primary point of contact for both internal teams and client stakeholders.
• Ensure scientific accuracy, consistency, and regulatory compliance across all documents.
• Facilitate review cycles, including comment management, resolution tracking, and document version control.
• Collaborate with SMEs (clinical, nonclinical, CMC, safety, biostatistics, regulatory) to gather data and ensure alignment with strategic messaging.
• Provide regulatory writing expertise and contribute to process improvements, templates, and best practices within the consultancy.

• Advanced degree in life sciences (PhD, PharmD, MSc, or equivalent).
• Minimum 5+ years of regulatory medical writing experience within pharma, biotech, or regulatory consultancy.
• Proven experience preparing scientific advice briefing packages, RMPs, and CTD Modules 2–5.
• Strong understanding of EMA, ICH, and related global regulatory guidelines.
• Exceptional writing, editing, and data‑interpretation skills.
• Ability to manage multiple workstreams, meet tight deadlines, and coordinate cross‑functional contributors.
• Detail‑oriented, proactive, and comfortable leading client‑facing interactions.

• Opportunity to lead high‑impact regulatory projects with innovative clients.
• Flexible remote/hybrid working arrangements.
• Supportive small‑team environment with direct influence on processes and project execution.
• Competitive compensation commensurate with experience.