Principal Medical Writer, FSP at IQVIA

Durham, North Carolina, United States

Apply Now

Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceutical, Clinical ResearchIndustries

Requirements

8+ years of experience in medical writing or related field
Bachelor's Degree in Life Sciences or related field (required)
Master's or PhD in Life Sciences or related field (preferred)

Responsibilities

Prepare assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs), customer requirements, and agreed timelines
Perform Senior Review of straightforward medical writing deliverables
Negotiate timelines and discuss/resolve customer comments
Provide written and verbal feedback to junior staff and customers when appropriate
Keep abreast of current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice (GCP), and developments in drug development/medical and/or technical writing
Write clear and concise clinical submission documents, including clinical study reports, protocols, clinical overviews, investigator brochures, and summary documents (experience with late-stage health authority responses is a plus)
Contribute to project plan concerning timelines, organization, and table layout for specific documents
Ensure documents meet regulations and key messages as defined by the team are clearly represented
Review and edit documents for consistency, progression, structure, and grammar
Review statistical analysis plans and incorporate into clinical study reports or submission documents as applicable
Drive the document preparation process, manage timelines, receive and review primary statistical output, draft and distribute documents for review, compile comments and edits, lead comment resolution meetings independently
Participate in team and client meetings as requested
Work independently on a range of complex clinical documents
Interpret, summarize, and present statistical and medical information to ensure accuracy in highly complex document types independently
Resolve complex problems independently

Skills

Key technologies and capabilities for this role

Medical WritingClinical Study ReportsProtocolsInvestigator BrochuresClinical OverviewsGCPStatistical Analysis PlansHealth Authority ResponsesSOPs

Questions & Answers

Common questions about this position

What is the salary range for the Principal Medical Writer position?

The potential base pay range for this role, when annualized, is $84,400.00 - $211,100.00. The actual base pay offered may vary.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What experience and education are required for this role?

Candidates need 8+ years of experience in medical writing or related field and a required Bachelor's Degree in Life Sciences or related field. A Master's or PhD in Life Sciences or related field is preferred.

What types of documents will I be working on as a Principal Medical Writer?

You will write clear and concise clinical submission documents, including clinical study reports, protocols, clinical overviews, investigator brochures, and summary documents; experience with late-stage health authority responses is a plus.

What makes a strong candidate for this Principal Medical Writer role?

Strong candidates have 8+ years of medical writing experience, a degree in Life Sciences, and the ability to independently handle complex clinical documents, manage timelines, and resolve issues while ensuring regulatory compliance.

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.

Land your dream remote job 3x faster with AI

Try Jobo Free