Position :
Medical Writer II / Senior Medical Writer
Location :
REMOTE - Spain, Poland, Hungary, Bulgaria
Client :
Global Clinical Research Organisation
Type :
Contract - Full-time - 12 months
Overview :
Planet Pharma is partnered with a leading global Clinical Research Organisation, currently hiring Medical Writer II and Senior Medical Writer roles, fully remote in Greece, Portugal, Spain, Poland, Hungary, and Bulgaria.
Main Responsibilities :
* 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), Reports (CERs)).
* Ensure timely, high-quality delivery of documents to clients.
* Collaborate closely with client teams and stakeholders to maintain excellent working relationships.
* Act as lead or contributing writer for submission projects.
* Provide mentorship and training to other medical writers.
* Manage writing activities, timelines, and task coordination.
* Analyze and summarize clinical data effectively.
* Lead writing discussions and integrate project strategies.
* Serve as main stakeholder contact and update project leads and managers.
* Represent medical writing in internal, client meetings, and project groups.
* Independently author other document types, including Pediatric Investigational Plans (PIPs), CTD/eCTD regulatory documents (IMPD, IND, MAA, NDA, sNDA), authority responses, and advisory meeting deliverables (briefing books, slides), as well as ad hoc clinical and regulatory documents.
Main Requirements :
* Experience in medical writing, including at least 2 years as a project lead in regulatory or clinical medical writing.
* Experience working within CROs or the pharmaceutical industry.
* Background in Life Sciences education.
* Proficiency with clinical and regulatory documents (protocols, ICFs, IBs, etc.).
About Planet Pharma :
Planet Pharma is an American-backed employment agency providing global staffing services, headquartered in Chicago with a regional office in Central London. We have built a strong international platform, working compliantly across 30+ countries, supporting over 2,500 active contractors globally, and offering robust permanent/recruitment solutions.
Our expertise and close industry relationships distinguish us in the field. Recently recognized as the 17th best professional staffing firm by FORBES, we have received multiple industry awards for excellence and service. Our core specialisms include Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions, Clinical Development, Biostatistics, and Medical Affairs/Writing.
We are committed to Equal Opportunity Employment, welcoming applications from all qualified candidates regardless of race, sex, disability, religion/belief, sexual orientation, or age.
www.planet-pharma.com
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