Senior Medical Writer

Planet Pharma; Sevilla; A distancia; EUR 50.000 - 70.000; Jornada completa

Descripción de la vacante

A global clinical research organization is seeking Medical Writers at II and Senior levels for remote positions in Spain and other countries. You will lead writing for complex clinical documents, ensuring high-quality delivery and mentoring other writers. The ideal candidate has 2+ years of medical writing experience and a life sciences background. This role offers the opportunity to collaborate with diverse project teams globally.

Formación

• Minimum of 2 years of medical writing experience.
• Experience in CRO or pharmaceutical industries.
• Proficiency with clinical and regulatory documents.

Responsabilidades

• Lead medical writer for complex clinical and regulatory documents.
• Ensure timely, high-quality delivery of documents.
• Mentor and train other medical writers.

Conocimientos

Medical writing

Project leadership

Regulatory documents proficiency

Clinical data analysis

Educación

Life sciences educational background

Descripción del empleo

Position: Medical Writer II / Senior Medical Writer

Location: REMOTE - Spain, Poland, Hungary, and Bulgaria

Client: Global Clinical Research Organisation

Type: Contract - Full-time - 12 months

Planet Pharma is partnered with a leading global Clinical Research Organisation, currently hiring Medical Writers (II and Senior levels) for fully remote positions in Greece, Portugal, Spain, Poland, Hungary, and Bulgaria.

Main Responsibilities:

1. Serve as lead medical writer for complex clinical and regulatory documents (e.g., informed consent forms (ICFs), lay summaries, Investigator Brochures (IBs), Clinical Evaluation Plans (CEPs), and Reports (CERs)).
2. Ensure timely, high-quality delivery of documents to clients.
3. Collaborate with client teams and stakeholders to maintain excellent working relationships.
4. Act as lead/contributing writer for submission projects.
5. Provide mentorship and training to other medical writers.
6. Manage writing activities, timelines, and task coordination.
7. Analyze and summarize clinical data effectively.
8. Lead writing discussions and integrate project strategies.
9. Serve as main stakeholder contact and update project leads and managers.
10. Represent medical writing in internal and client meetings and project groups.
11. Authored document types include Pediatric Investigational Plans (PIPs), CTD/eCTD regulatory documents (IMPD, IND, MAA, NDA, sNDA), authority responses, briefing books, slides, and other ad hoc clinical/regulatory documents.

Main Requirements:

1. At least 2 years of medical writing experience including project leadership in regulatory/clinical medical writing.
2. Experience working in CRO or pharmaceutical industries.
3. Life sciences educational background.
4. Proficiency with clinical and regulatory documents (protocols, ICFs, IBs, etc.).

Planet Pharma is an American-owned employment agency with headquarters in Chicago and an EMEA regional office in Central London. We offer global staffing services across 30+ countries, with a network of over 2,500 contractors and strong permanent recruitment capabilities. Recognized by FORBES as the 17th best professional staffing firm, we excel in regulatory affairs, pharmacovigilance, QA, QC, clinical development, biostatistics, and medical affairs/writing. We are committed to equal opportunity employment and welcome applicants from all backgrounds.