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About the Role

Acts as Lead Medical Writer on most types of writing projects, preparing assigned documents in accordance with IQVIA SOPs and customer requirements within agreed timelines. Performs Senior Review of straightforward medical writing deliverables, negotiates timelines, and resolves customer comments. Provides feedback to junior staff and customers, and stays updated on medical writing and regulatory knowledge.

Responsibilities

Take a leading role in preparing assigned documents, including confirming scope, templates, and specifications.
Negotiate and adhere to timelines, organize document reviews, and communicate directly with the customer.
Plan and organize workload for assigned projects and tasks, identifying project needs, tracking timelines, and implementing customer requests.
Lead meetings on challenging topics independently.
Present on standard Medical Writing processes at bid defense meetings.
Assist in the training and development of junior staff, either formally as a mentor or ad hoc.
Develop and deliver training to the global team on specific expertise areas.
Input into and deliver presentations on Medical Writing to other IQVIA groups.
Act as Project Manager for complex medical writing projects, including finance and invoicing.
Complete project finance activities, including monitoring and forecasting budgeted hours.
Propose, review, and approve budgets and costings for routine projects, including estimating hours for medical writing tasks.
Take on a small customer lead role or assist an established partnership lead.
Represent region or site on a Medical Writing initiative or cross-functional initiative.
Facilitate and brainstorm the identification of new ideas.
Represent Medical Writing at a general capabilities audit.

Requirements

Bachelor's Degree in 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 5 years of highly relevant experience and related competency levels.
In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents.
Ability to identify deficiencies, errors, and inconsistencies in a protocol or report.
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 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 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 medical terminology across a range of therapeutic areas.
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.
Able to deliver difficult messages in a constructive manner.
Demonstrates initiative and sound judgement when faced with less familiar project/document situations or challenges.
Demonstrated abilities in collaboration with others and independent thought.
Demonstrates confidence and maturity in most routine medical writing situations.
Demonstrates good judgement in requesting input from senior staff.
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, seek solutions, and discuss appropriately with colleagues and customers.
Must be computer literate.

Skills

Medical writing
Clinical study reports
Protocols
Statistical methods
Data integration
Data interpretation
Data summarization
Drug development
Regulatory knowledge
Statistical principles
Medical terminology
Written communication
Oral communication
Grammatical writing
Technical writing
Attention to detail
Accuracy
Communication
Negotiation
Collaboration
Independent thought
Project management
Risk evaluation
Problem-solving
Computer literacy

Location

Canada
Home-Based

Work Type

Home-Based

Experience Level

Lead
Senior
5 years of highly relevant experience

Education Level

Bachelor's Degree in life sciences or related field
Master's Degree in life sciences or related field
Ph.D. in life sciences or related field

Salary/Compensations

$99,500.00 - $132,600.00

Benefits

Health benefits
Wellness benefits

About the Company

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries.
We create connections that accelerate the development and commercialization of innovative medical treatments.
Everything we do is part of a journey to improve patient outcomes and population health worldwide.
To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact.
No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere.

Equal Opportunity

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, marital status, or any other status protected by applicable law.
Accommodations for applicants with disabilities are available in all aspects of the recruitment process upon request.
IQVIA is committed to integrity in its hiring process and maintains a zero tolerance policy for candidate fraud.
Please note that we may use artificial intelligence (AI) in the processing of your application. However, we only use AI to assist our recruitment team with the screening or assessment of candidacies, and not as a substitute for human decision-making.