Medical Writing Manager (Regulatory Writing)

Описание

Job Overview

Acts as Lead Medical Writer on any type of writing project, including projects with multiple deliverables/components. 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 all types of medical writing deliverables. Provides feedback and guidance to more junior staff. Negotiates timelines and discusses/resolves customer comments. 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.

Essential Functions

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.

Use experience and initiative to tackle new/unusual document types and customer requirements.

Lead meetings on more challenging topics independently and act as point of contact for escalations and resolve conflict.

Participate in bid defense meetings and discussions.

May design training materials and input into generic training plans for staff. Proposes topics for and prepares and delivers knowledge-sharing sessions for the global team. May propose, plan and deliver general training on Medical Writing to other IQVIA groups and externally, as appropriate.

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.

Independently propose, review and approve budgets and assumptions for a range of project types within remit.

May take on a partnership lead role.

Likely to represent region or site on a Medical Writing initiative or cross-functional initiative.

May draft new Medical Writing Standard Operating Procedures (SOPs) for review and act as reviewer for Medical Writing SOPs, as assigned and appropriate.

Qualifications and Experience and Skills

Bachelor's Degree n life sciences related discipline or related field required

Master's Degree in life sciences related discipline or related field preferred

Ph.D. in life sciences related discipline or related field preferred

Typically requires at least 7 years of highly relevant experience in regulatory writing and related competency levels.

In-depth knowledge of the structural and content requirements of clinical study reports (CSR), Common Technical Documents (CTD), protocols, and similar documents and ability to identify deficiencies, errors, and inconsistencies in a protocol or report.

Experienced in preparing CTDs and/or tackling new/unusual document types/customer requirements.

Good understanding of common statistical methods used in clinical trials and/or interpretation of their results.

Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output

Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.

Significant experience as a lead writer in preparing CSRs, CTDs and protocols, with consistently positive feedback from customers and colleagues.

In depth knowledge of drug development, medical writing, and associated regulations.

Good understanding of statistical principles and of medical terminology across a range of therapeutic areas.

​Skills and Abilities

Excellent written and oral communication skills including grammatical/technical writing skills.

Excellent attention to detail and accuracy.

Confident and effective communication and negotiation skills with customers and project managers.

Demonstrated ability to remain calm and assertive yet diplomatic in more challenging interactions with customers and colleagues.

Demonstrates initiative and sound judgement when faced with less familiar project/document situations or challenges.

Demonstrated abilities in collaboration with others and independent thought.

Demonstrated ability to influence others without having official authority.

Demonstrates good judgement in requesting input from senior staff.

Demonstrates confidence and maturity in most routine medical writing situations.

Ability to establish and maintain effective working relationships with coworkers, managers and customers.

Ability to effectively manage multiple tasks and projects.

Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with colleagues and customers.

Confidence in appropriately challenging the customer when document quality or timelines are at risk.

Must be computer literate.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at