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    Senior Medical Writer (Clinical Pharmacology)

    Propharma
    5+ years
    Not Disclosed
    United States
    10 Jan. 3, 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

    Job Title: Senior Medical Writer
    Company: ProPharma Group
    Location: Remote
    Position Type: Full-Time

    About ProPharma Group

    For the past 20 years, ProPharma has been at the forefront of improving patient health by empowering biotech, pharmaceutical, and medical device organizations to confidently bring new therapies and innovations to market. As the world’s largest Research Consulting Organization (RCO), ProPharma offers comprehensive, customizable solutions across the product lifecycle. With deep expertise in regulatory sciences, clinical research, pharmacovigilance, quality & compliance, and more, ProPharma accelerates the success of its clients' high-profile drug and device programs.

    Position Overview

    ProPharma is seeking a Senior Medical Writer to lead the creation of high-quality medical writing deliverables. This role requires a strong focus on regulatory standards, quality, and efficiency, as well as the ability to manage multiple projects in various therapeutic areas. The Senior Medical Writer will work with minimal supervision, support clients directly, and mentor less experienced writers.

    Key Responsibilities

    • Authoring Medical Documents:

      • Write and edit clinical, safety, regulatory, device, and diagnostic documents (e.g., protocols, study reports, patient narratives, regulatory submissions like IND, NDA, BLA, PBRER).

    • Client Interaction:

      • Manage client expectations, lead team meetings, and communicate directly with clients regarding project timelines and deliverables.

    • Collaboration & Mentorship:

      • Collaborate with cross-functional teams (clinical operations, biostatistics, etc.) and mentor less experienced medical writers.

    • Quality Control:

      • Review statistical analysis plans, table/figure/listing shells, and other documents for accuracy, consistency, and adherence to guidelines.

    • Project Management:

      • Manage multiple deliverables/projects simultaneously, track timelines, and ensure on-time, within-budget delivery.

    • Regulatory Knowledge:

      • Stay updated on current industry practices, regulatory requirements, and guidelines related to medical writing.

    • Process Improvement:

      • Participate in departmental initiatives aimed at improving efficiency and quality.

    Necessary Skills and Abilities

    • Clinical Research Expertise:

      • Advanced knowledge of clinical research principles, FDA regulations, and other relevant guidelines.

    • Project Management:

      • Strong organizational, time-management, and communication skills.

    • Writing Proficiency:

      • Expert MS Word skills (tables, graphs, figures) and familiarity with AMA style.

    • Collaboration:

      • Experience building relationships and collaborating with key stakeholders.

    • Proactive Problem-Solving:

      • Ability to identify inefficiencies and suggest improvements to management.

    Educational Requirements

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

    Experience Requirements

    • Minimum 5 years of experience in clinical and/or regulatory writing for drugs, biologics, and/or medical devices/diagnostics.

    • Experience in contract research organizations, pharmaceutical companies, or biotechnology firms preferred.

    Additional Information:

    • ProPharma fosters a workplace of diversity, equity, and inclusion, encouraging employees to be their authentic selves and contribute to an innovative, collaborative environment.
    • #LI-Remote
    • Note: ProPharma does not accept unsolicited resumes from recruiters or third parties.

    How to Apply:

    Interested candidates should apply directly through ProPharma’s career portal.

    Let me know if you need further assistance!

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    Midrand | South Africa |

    Brazil :

    Brazil | Sao paulo |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hà Nội | Hanoi |

    Ho Chi Minh :

    Ho Chi Minh City |