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Senior Medical Writer (m/w/d)

Aplica ya
Mapa de ubicación: Frankfurt/Main, Hesse, Germany Full time R1258788

Descripción del trabajo

Job Family Description

Writes, reviews, and coordinates technical documentation regarding clinical trials in line with client specifications and industry practices.

Sub-Family Description

Prepares, or contributes to the preparation of clinical and/or regulatory documents, for either internal customers or external clients, for investigational drugs, biologicals, or medical devices. Collaborates with internal and/or external experts and specialists; maintains expertise on developments in a particular field of focus.

JOB OVERVIEW

Job Profile Summary Acts as Lead Medical Writer on most types of writing projects. Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs) and customer requirements as well as to the agreed timelines. Performs Senior Review of straightforward medical writing deliverables. Negotiates timelines and discusses/resolves customer comments. Provides written and verbal feedback to junior staff, and to customers when appropriate. Keeps abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in drug development/medical and/or technical writing.

Responsibilities:

• Take a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews, communicating directly with the customer.

• Plan and organize workload for assigned projects and tasks: identify project needs, track timelines and implement customer requests.

• Lead meetings on more challenging topics independently.

• May present on standard Medical Writing processes at full-service bid defense meetings.

• Assist in the training and development of junior staff, either formally as an assigned mentor or ad hoc for local colleagues or others. May develop and deliver training to the global team on a topic he/she has specific expertise in. May input into and deliver presentations on Medical Writing to other IQVIA groups.

• May act as Project Manager for a more complex but single Medical Writing

project which includes Project Finance/Invoicing responsibilities.

• Complete project finance activities, including monitoring and forecasting budgeted hours. Responsibilities Essential Functions

• Propose, review and approve budgets and costings for routine projects, including estimation of hours needed for Medical Writing tasks.

• May take on a small customer lead role or assist an established partnership lead in their role.

• May represent region or site on a Medical Writing initiative or cross-functional initiative.

• Facilitates and brainstorms the identification of new ideas. May represent Medical Writing at a general capabilities audit.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.

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