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    Medical Writer

    Propharma
    0-2 years
    Not Disclosed
    United States
    10 Feb. 13, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Position Title: Medical Writer I
    Location: United States
    Employment Type: Full-time
    Posted: 9 Days Ago
    Job Requisition ID: JR 6495

    About ProPharma:
    For over 20 years, ProPharma has been improving the health and wellness of patients by providing valuable expertise to biotech, med device, and pharmaceutical companies. As the world’s largest Research Consulting Organization (RCO), we partner with clients through an advise-build-operate model across the entire product lifecycle. Our services span regulatory sciences, clinical research, quality & compliance, pharmacovigilance, medical information, and more. We work to accelerate and de-risk drug and device programs globally.

    Position Overview:
    The Medical Writer I will be responsible for authoring high-quality medical writing deliverables with a focus on accuracy, efficiency, and quality. This position provides medical writing support to ProPharma clients across various domains, including clinical, regulatory, safety, and more.

    Key Responsibilities:

    • Author and edit medical writing deliverables, including but not limited to protocols, study reports, patient narratives, Investigator’s Brochures (IBs), Informed Consent Forms (ICFs), clinical study reports, and regulatory documents (PBRER, IND, NDA, BLA, MAA, eCTD submissions).
    • Ensure adherence to regulatory standards and guidelines, such as ICH E3/E6(R2), EU MDR/IVDR, and client-specific templates.
    • Collaborate with cross-functional teams to produce high-quality medical writing deliverables.
    • Participate in and/or lead team meetings, including project kickoffs and comment reviews, and manage deliverable timelines with guidance from senior personnel.
    • Perform quality control (QC) reviews of documents and track changes as applicable.
    • Assist with administrative tasks like maintaining timelines, updating deliverable trackers, and hosting internal/client meetings.
    • Stay updated with current industry practices, regulatory requirements, and guidelines.
    • Work within the allocated budgeted hours and communicate out-of-scope tasks to medical writing leadership.

    Necessary Skills and Abilities:

    • Basic knowledge of clinical research principles and regulatory requirements.
    • Understanding of FDA regulations and other applicable regulatory guidelines.
    • Proficient in MS Word, including word processing, tables, graphs, and figures.
    • Strong communication skills, attention to detail, and project management skills.
    • Familiarity with the American Medical Association (AMA) style.
    • Ability to work independently and collaborate effectively within a team.
    • Proactive, growth-oriented mindset with a willingness to take on challenges.

    Educational Requirements:

    • Bachelor’s degree or higher, preferably in a medical or scientific discipline.

    Experience Requirements:

    • 0-2 years of experience in writing clinical and/or regulatory documents, or relevant experience in reviewing scientific data or documents.
    • Experience in a contract research organization, pharmaceutical company, or biotechnology company is preferred.

    Why Join ProPharma:
    ProPharma is committed to diversity, equity, and inclusion, creating a workplace where all employees can thrive. We provide a safe space where every individual is empowered to succeed and encouraged to innovate.

    Equal Opportunity Employer:
    ProPharma Group is an Equal Opportunity Employer, ensuring a respectful and inclusive environment for all employees.

     

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    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |