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 at different levels, fully remote in Greece, Portugal, Spain, Poland, Hungary, and Bulgaria.
Main Responsibilities:
* 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 and high-quality delivery of documents to clients.
* Collaborate with client teams and stakeholders to maintain excellent working 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 as a medical writing project lead (regulatory/clinical medical writing).
* Experience working in the 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 business 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 worldwide and expertise in regulatory affairs, pharmacovigilance, QA, QC, clinical development, and more.
We are committed to equal opportunity employment and welcome applications from all qualified candidates regardless of race, sex, disability, religion, sexual orientation, or age.
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