CSR/Protocol/IB - Senior Medical Writer
Posted on: September 16, 2023
IQVIA CSR/Protocol/IB - Senior Medical Writer Huntsville ,
Alabama Apply Now Remote Opportunity - Located in the USA or
*Please include a cover letter.
The Senior Medical Writer will act as Lead Medical Writer on most
types of regulatory writing projects; Will prepare assigned
documents in accordance with IQVIA Standard Operating Procedures
(SOPs) and customer requirements, per agreed timelines; Will
perform Senior Review of straightforward medical writing
deliverables, and negotiate timelines and discuss/resolve customer
comments; Will provide written and verbal feedback to junior staff,
and to customers when appropriate; Will keep abreast of current
medical writing and regulatory knowledge, including Good Clinical
Practice (GCP), along with developments and advances in clinical
Senior MW requires 5+ years of writing experience, including acting
as Lead Writer, for entire Clinical Study Reports (CSRs), Clinical
Study Protocols, and Investigator Brochures, with consistently
positive feedback from customers and colleagues.
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
Plan and organize workload for assigned projects and tasks:
identify project needs, track timelines and implement customer
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
Complete project finance activities, including monitoring and
forecasting budgeted hours.
Propose, review and approve budgets and costings for routine
projects, including estimation of hours needed for Medical Writing
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
Facilitates and brainstorms the identification of new ideas. May
represent Medical Writing at a general capabilities audit.
5+ years of writing experience, including acting as Lead Writer,
for Clinical Study Reports (CSRs), Clinical Study Protocols, and
Investigator Brochures, with consistently positive feedback from
customers and colleagues.
Bachelor's Degree in life sciences or related field is Required;
Master's Degree and/or Ph.D. in life sciences or related field is
In depth knowledge of drug development, medical writing, and
In-depth knowledge of the structural and content requirements of
clinical study reports, protocols, and similar documents, and
ability to identify deficiencies, errors, and inconsistencies in a
protocol or report.
Good understanding of statistical principles and of medical
terminology across a range of therapeutic areas.
Ability to effectively review a statistical analysis plan and to
identify deficiencies, errors, and inconsistencies in statistical
Ability to integrate, interpret, and summarize data from a variety
of sources in a clear and concise manner.
Equivalent combination of education, training and experience.
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.
Demonstrates initiative and sound judgement when faced with less
familiar project/document situations or challenges.
Demonstrated abilities in collaboration with others and independent
Demonstrates confidence and maturity in most routine medical
Demonstrates good judgement in requesting input from senior
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
Must be computer literate.
IQVIA is a leading global provider of advanced analytics,
technology solutions and clinical research services to the life
sciences industry. 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. Learn more at
We are committed to providing equal employment opportunities for
all, including veterans and candidates with disabilities.
As the COVID-19 virus continues to evolve, IQVIA's ability to
operate and provide certain services to customers and partners
necessitates IQVIA and its employees meet specific requirements
regarding vaccination status.
IQVIA is a world leader in using data, technology, advanced
analytics, and expertise to help customers drive healthcare - and
human health - forward. Together with the companies we serve, we
are enabling a more modern, more effective and more efficient
healthcare system, and creating breakthrough solutions that
transform business and patient outcomes.
To get there, it takes diverse skills and a curiosity to explore
new possibilities. No matter your role, everyone at IQVIA,
including our colleagues at Q - Solutions, contributes to our
shared goal of improving human health. Thank you for your interest
in growing your career with us.
EEO Minorities/Females/Protected Veterans/Disabled
Keywords: IQVIA, Huntsville , CSR/Protocol/IB - Senior Medical Writer, Accounting, Auditing , Huntsville, Alabama
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