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 global leading Clinical Research Organisation, currently hiring Medical Writers (II and Senior level) for fully remote positions 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), and Reports (CERs)).
* Ensure timely, high-quality delivery of documents to clients.
* Collaborate with client teams and stakeholders to maintain excellent relationships.
* Act as lead/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.
Other Document Types Authored Independently:
* Pediatric Investigational Plans (PIPs).
* CTD/eCTD regulatory documents (e.g., IMPDs, INDs, MAAs, NDAs, sNDAs).
* Authority responses and advisory meeting deliverables (briefing books, slides).
* Other ad hoc clinical and regulatory documents.
Main Requirements:
* At least 2 years of experience in medical writing, including project leadership in regulatory/clinical writing.
* Experience working in CRO or pharmaceutical industry.
* Life Sciences educational background.
* Experience with clinical and regulatory documents (protocols, ICFs, IBs, etc.).
About Planet Pharma:
Planet Pharma is an American parented employment agency providing global staffing services, with headquarters in Chicago and an EMEA regional office in London. We operate in over 30 countries with a network of 2500+ active contractors and offer permanent and contract recruitment services.
Recognized by Forbes as the 17th best professional staffing firm, we have received multiple industry awards. Our expertise spans Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions, Clinical Development, Biostatistics, and Medical Affairs/Writing.
We are committed to equal opportunities and welcome applications from all qualified candidates regardless of race, sex, disability, religion, sexual orientation, or age.
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