|Job Category :||Content Writing|
|Company Name:||Piper Companies|
|Position Name:||Senior Principal Medical Writer (Remote)|
|Job Description :||Piper Clinical Solutions is seeking a Senior Medical Writer (Remote) to support an established clinical research organization with communications and document development activities for ongoing research trials. This role is 100% remote Responsibilities for the Senior Medical Writer (Remote): Coordinate, attend, and lead conference calls and meetings related to clinical trials Responsible for writing and reviewing study related documents including SOPs (Standard Operating Procedure), Protocols, Data Collection Documents, Investigator Brochures, Clinical Study Reports, and ICF (Informed Consent Forms) forms Perform QC (quality control) on all documents to ensure compliance with regulatory requirements Responsible for writing content and formatting clinical reports and regulatory documents Develop scientific communication documents such as posters, manuscripts, publications and abstracts Participate in high-level internal and external engagements and prepare meeting minutes/action items for bid defense meetings Perform literature searches and assist in the development of protocols Analyze medical research data to prepare study findings and reports Requirements for the Senior Medical Writer (Remote): 3+ years of professional experience in Medical Writing/Scientific Writing within a CRO (Clinical Research Organization), Pharmaceutical, or Biotechnology organization Excellent oral and written communications skills, attention to detail, and organization skills Master’s degree or PhD in a science related field Compensation for the Senior Medical Writer (Remote): Salary up to $160,000 based on years of relevant experience Benefits: Health, Dental, and Vision Insurance and 401K, Holidays, PTO (Paid Time Off) Keywords: CRO, Clinical research organization, clinical trials, pharmaceutical, biotechnology, biotech, medical writer, scientific writer, science writer, science editor, senior medical writer, medical writing, scientific writing, editing, regulatory specialist, regulatory writing, regulatory revisions, investigator brochures, regulatory, SOP, standard operating procedure, data collection documents, CSR, clinical study report, protocol, protocol development, scientific communications, medical communications, regulatory guidelines, regulatory affairs, IRB, IRB submissions, institutional review board, manuscript, publication, abstract, co-author, author, meeting minutes, ICF, informed consent form, CRF, case report form, bid defense, clinical research, clinical trials, oncology clinical trials, oncology trials, investigator initiated, cardiology, hematology, infectious disease, GCP, good clinical practice, PhD, doctor of philosophy, remote, health insurance, med com Keywords: Good Clinical Practice, GCP, IRB, international review board, FDA, pharmacology, toxicology, biochemistry, biology, chemistry, immunology, clinical trials, ICH, regulatory documents, data management, tmf, trial master file, standard operating procedures, protocols, adherence, sop|
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