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 are partnered with a global leading Clinical Research Organisation, who are currently hiring a Medical Writer II and a Senior Medical Writer, fully remote in the following locations : 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), and lay summaries, Investigator Brochures (IBs), Clinical Evaluation Plans (CEPs), and 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 / 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 :
* Working experience in medical writing experience including 2 years as medical writing project lead (regulatory / clinical medical writing)
* Experience working in the CRO or Pharmaceutical industry only
* Life Sciences educational background
* Experience with the above clinical and regulatory documents (protocols, ICFs, IBs etc)
Planet Pharma is an American parented Employment Business / Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.
Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including : Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.
We are an equal opportunities Recruitment Business and Agency.
We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion / belief, sexual orientation or age.
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