Director, Nonclinical and Clinical Pharmacology Writing - [TC613]

Hobson Prior; Barcelona; Presencial; EUR 70.000 - 90.000; Jornada completa

Descripción de la vacante

A prominent biotechnology firm in Barcelona is seeking a Director of Nonclinical and Clinical Pharmacology Writing to lead the creation of high-quality regulatory documents. The ideal candidate will have strong regulatory writing experience and a collaborative mindset. This role involves ensuring timely delivery of materials and mentoring team members. The company offers a vibrant working environment aligned with life sciences excellence.

Formación

• Strong experience in regulatory medical writing, especially leading submissions.
• Ability to summarize complex data into clear regulatory documents.
• In-depth knowledge of global regulatory requirements and ICH-GCP guidelines.
• Experience in managing and mentoring medical writers.

Responsabilidades

• Develop and implement strategies for regulatory documents.
• Write and manage clear and organized NCCP documents.
• Review and ensure quality of documents prepared by others.
• Mentor and guide team members.

Conocimientos

Regulatory medical writing

Data summarization

MS Office proficiency

Excellent communication skills

Knowledge of global regulatory requirements

Mentoring skills

Descripción del empleo

Join a trailblazing biotech on the cutting edge of science and technology.

Hobson Prior is seeking a Director of Nonclinical and Clinical Pharmacology Writing to join a biotechnology organization in Barcelona, Spain. In this role, you will oversee the creation of high-quality regulatory documents that support clinical development programs. You will lead writing activities for nonclinical and clinical pharmacology (NCCP) across various disease areas, ensuring timely and accurate delivery of materials. This position requires a proactive leader who can work independently while collaborating with cross-functional teams.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:





- Develop and implement strategies for creating regulatory documents, including early-stage protocols, investigator brochures, and summaries for submissions.
- Contribute to briefing packages, responses to health authority inquiries, and other global regulatory submission documents.
- Write and manage clear, accurate, and well-organized NCCP documents that meet regulatory and internal guidelines.
- Represent the medical writing team in cross-functional discussions and negotiate timelines as needed.
- Review and ensure the quality of documents prepared by others, maintaining consistency and adherence to standards.
- Mentor and guide team members, fostering their professional growth and ensuring high-quality outputs.
- Collaborate with colleagues across departments to maintain compliance with regulatory requirements and internal processes.

Key Skills and Requirements:

- Strong experience in regulatory medical writing, including leading global submissions.
- Ability to summarize complex scientific data into clear and concise regulatory documents.




- Proficiency in MS Office tools and excellent communication skills (written and verbal).
- In-depth knowledge of global regulatory requirements and ICH-GCP guidelines.
- Experience managing and mentoring medical writers, both internal and external.
- A collaborative mindset with a strong sense of ethics and responsibility.
- Ability to work effectively in an office environment, utilizing technology for communication and problem-solving.

For more information, please contact Henry LeLacheur .

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe.



Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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https://www.kitempleo.es/empleo/221748815/director-nonclinical-and-clinical-pharmacology-writing-tc613-barcelona/?utm_source=html