Senior Medical Writer (Regulatory Writing) at IQVIA

Barcelona, Catalonia, Spain

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Not SpecifiedCompensation

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

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Clinical ResearchIndustries

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 in regulatory writing and related competency levels
In-depth knowledge of the structural and content requirements of clinical study reports (CSR), protocols, and similar documents and 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 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 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
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 constructive manner
Demonstrates initiative and sound judgement when faced with less familiar project/document situations or challenges

Responsibilities

Acts as Lead Medical Writer on most types of writing projects
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 straightforward medical writing deliverables
Negotiates timelines and discusses/resolves customer comments
Provides written and verbal feedback to junior staff, and to customers when appropriate
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
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 responsibilities
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 tasks
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 cross-functional initiative
Facilitates and brainstorms the identification of new ideas. May represent Medical Writing at a general capabilities audit

Skills

Key technologies and capabilities for this role

Medical WritingRegulatory WritingGood Clinical PracticeSOP ComplianceProject ManagementBudget ForecastingTraining and MentoringDrug Development

Questions & Answers

Common questions about this position

What education is required for the Senior Medical Writer role?

A Bachelor's Degree in a life sciences related discipline or related field is required, with a Master's or Ph.D. preferred.

What experience is needed for this position?

Typically at least 5 years of highly relevant experience in regulatory writing and related competency levels is required.

What key skills are essential for the role?

In-depth knowledge of the structural and content requirements of clinical study reports (CSR), protocols, and similar documents, ability to identify deficiencies, errors, and inconsistencies, and good understanding of common statistical methods used in clinical trials are essential.

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

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

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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