Senior Medical Writer

Parexel; Valencia; A distancia; EUR 40.000 - 65.000; Jornada completa

Descripción de la vacante

A leading biopharmaceutical company is seeking a Senior Medical Writer to join their expanding team. This fully home-based role involves overseeing document creation for clinical research, contributing to regulatory submissions, and providing technical mentorship. The position offers a competitive salary, bonus, and various benefits, fostering professional development within a dynamic industry environment.

Servicios

Structured career pathway

Development opportunities

Competitive salary

Bonus

Pension

Holiday

Leading-edge perks

Formación

• Extensive clinical / scientific writing experience as a Senior or Principal Medical Writer.
• Understanding of clinical research, drug development, and industry guidelines.
• Fluent in English, with strong attention to language detail.

Responsabilidades

• Research, create, and edit clinical documents for regulatory submissions.
• Manage contributions from multiple writers and ensure document quality.
• Provide leadership and strategic planning in project management.

Conocimientos

Interpersonal skills

Negotiation skills

Verbal communication

Written communication

Organizational skills

Leadership abilities

Problem-solving

Educación

Bachelor's degree in Life Sciences / Health-Related Sciences

Herramientas

MS Office

Document management systems

SharePoint

Descripción del empleo

When our values align, there's no limit to what we can achieve.

Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values : Patients First, Quality, Respect, Empowerment & Accountability.

We are looking for a Senior Medical Writer due to an expanding team. These roles can be fully home-based in various European countries.

As a Senior Medical Writer, you will research, create, and edit all documents associated with clinical research. You will operate as the project lead writer / submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. You will also facilitate process improvement, provide technical mentoring / training, and support Medical Writing Services management during the sales process by providing client liaison and proposals input.

Key Accountabilities :

• Gather, review, analyze, and evaluate resources to prepare, develop, and finalize clinical documents for regulatory submission, including briefing documents, investigator brochures, study protocols, informed consents, clinical study reports, CTD overviews and summaries, safety reports, and integrated summaries of safety and efficacy.
• Revise document drafts based on review comments to ensure all relevant input is included, and ensure high-quality work prior to distribution or shipment.
• Provide medical editing review of drafts prepared by other writers, including copyediting and content review.
• Manage contributions of multiple writers, scope of work, timelines, project goals, and client inputs throughout the project.
• Develop and oversee work plans for document delivery to meet milestones and objectives.
• Provide leadership, strategic planning, delegation, and task management within the team.
• Maintain awareness of client expectations and respond to dissatisfaction appropriately, providing feedback to management.
• Support business development efforts, including identifying leads, attending meetings, and preparing sales presentations.
• Stay updated on advances in medical writing and regulatory issues.
• Develop and train staff to enhance writing quality, efficiency, and project management.
• Implement and monitor compliance with SOPs, contributing to their development or revision.
• Participate in departmental and company meetings, and ensure adherence to procedures and workload tracking.
• Analyze work efficiency and discuss improvements with management and colleagues.

Education :

• Bachelor's degree in Life Sciences / Health-Related Sciences or equivalent.

Skills :

• Excellent interpersonal, negotiation, verbal, and written communication skills.
• Flexible attitude towards work assignments and learning.
• Motivated to work in a fast-paced, changing environment.
• Ability to manage multiple tasks with attention to detail and organizational skills.
• Teamwork skills, cross-cultural sensitivity, and leadership abilities.
• Sound judgment, problem-solving, and client relationship skills.

Knowledge and Experience :

• Understanding of clinical research, drug development, and industry guidelines (e.g., ICH-GCP).
• Extensive clinical / scientific writing experience as a Senior or Principal Medical Writer.
• Scientific background with experience in clinical documents such as reports, protocols, or CTD documents.
• Proficiency in MS Office, document management systems, SharePoint, and databases.
• Fluent in English, with strong attention to language detail.

In return, we offer a structured career pathway, development opportunities, a competitive salary, bonus, and benefits including holiday, pension, and other leading-edge perks.

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