Principal Medical Writer at IQVIA

Durham, North Carolina, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceutical, Clinical ResearchIndustries

Requirements

Bachelor's Degree (or experience equivalent) in life sciences related discipline or related field
Master's Degree (or experience equivalent) in life sciences related discipline or related field
Ph.D. (or experience equivalent) in life sciences related discipline or related field
Typically requires at least 7 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 and ability to identify deficiencies, errors, and inconsistencies in documents
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
Extensive experience in preparing CSRs and protocols independently to a consistently high standard, regardless of complexity or challenges
Experienced in preparing CTDs and/or tackling new/unusual document types/customer requirements
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
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

Responsibilities

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
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
Chair meetings. Able to 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 small series of Medical Writing projects, that may involve elements of other functions
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

Skills

Key technologies and capabilities for this role

Medical WritingGCPSOP ComplianceRegulatory WritingProject ManagementDrug DevelopmentTraining DeliveryBudget ForecastingBid DefenseClinical Documentation

Questions & Answers

Common questions about this position

What qualifications and experience are required for the Principal Medical Writer role?

Candidates need a Bachelor's, Master's, or Ph.D. in a life sciences related discipline (or equivalent experience), plus typically at least 7 years of highly relevant experience. In-depth knowledge of clinical study reports, protocols, and similar documents is required, along with understanding of common statistical methods in clinical trials.

What is the salary or compensation for this position?

This information is not specified in the job description.

Is this a remote position, or is there a location requirement?

This information is not specified in the job description.

What does the company culture or work environment look like for this role?

This information is not specified in the job description.

What makes a strong candidate for the Principal Medical Writer position?

Strong candidates have at least 7 years of highly relevant experience, in-depth knowledge of clinical documents like study reports and protocols, and the ability to lead projects, negotiate timelines, review deliverables, and provide guidance to junior staff.

IQVIA

Advanced analytics and clinical research services

About IQVIA

IQVIA provides advanced analytics, technology solutions, and clinical research services specifically for the life sciences industry. Their services utilize extensive data resources and technology to create connections within healthcare, allowing clients to gain insights that help speed up the development and marketing of new medical treatments. This process is facilitated by their IQVIA Connected Intelligence™ system, which offers quick and flexible insights. IQVIA stands out from competitors by focusing on patient privacy, employing various technologies to protect individual data. The company's goal is to enhance healthcare outcomes by supporting biotech, pharmaceutical, and medical device companies, as well as researchers and government agencies, in understanding diseases and advancing medical science.

Durham, North CarolinaHeadquarters

1998Year Founded

$3,526MTotal Funding

POST_IPO_EQUITYCompany Stage

Cybersecurity, Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Rapid advancement of cancer vaccines may disrupt traditional clinical research models.

Proliferation of disparate technological solutions causes technology overload in clinical trials.

Generative AI technologies face challenges in adoption due to data privacy concerns.

Differentiation

IQVIA leverages advanced analytics and big data for life sciences solutions.

The company offers privacy-enhancing technologies to protect individual patient data.

IQVIA's AI Assistant provides rapid, actionable insights for healthcare and life sciences.

Upsides

Increased adoption of decentralized clinical trials enhances patient-centric study designs.

AI-driven drug discovery accelerates identification of potential drug candidates.

Expansion of telemedicine facilitates remote patient monitoring and data collection.

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