IQVIA Senior Medical Writer, Patient Centered Endpoints in New York, New York
IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Senior Medical Writer, Patient Centered Endpoints - NYC
The Senior Medical Writer for Patient Centered Endpoints supports client projects and internal IQVIA thought leadership initiatives by undertaking writing of regulatory briefing books, dossiers, abstracts, posters, manuscripts and presentations as an integrated member of the project team. The role acts a senior advisor on writing deliverables to the project team and coaches and develops junior members of the Medical Writing team. The role participates in a portfolio of projects and maintains high standards of scientific output and effective process management to all project deadlines.
Develop outlines and drafts of abstracts, posters, manuscripts and presentations with limited review required from senior project team members.
Integrate the multiple arguments and evidence streams developed by a project team and develop well-structured, clear, and concise regulatory briefing documents and evidence dossiers.
Participate in both internal and external project team meetings.
Facilitate appropriate internal review of assigned documents and take responsibility for on-time delivery.
Manage formal requirements of document production and review cycles including formats and procedures such as ICMJE, GPP and company SOPs.
May perform QC review of documents or parts of documents prepared by other staff.
Participate as a lead writer on several project teams concurrently and take responsibility for managing workload for assigned projects and tasks, in collaboration with senior staff.
Keep abreast of COA-related research with extensive knowledge of COA-related regulatory and scientific framework.
Take responsibility for execution of assigned projects to a high standard.
Review and monitor resource requirements for assigned projects and support effective delivery of the project within budget.
Identify the best suitable staff resources for projects and any knowledge or capability gaps.
Give guidance to less experienced team members and assists in their training and development.
May act as Project Manager for patient-centered-endpoint projects where the core of the task is a written deliverable.
Present at international congresses when needed.
May propose revisions to SOPs or suggest process improvements for consideration.
Line manager responsibilities for 1-3 medical writers
Perform other qualitative tasks such as literature review or production of study reports (qualitative and quantitative).
Support proposal writing and business development activities.
Maintain proficiency of skills and knowledge and remains current with industry trends based current literature, application of new technology, attendance at professional meetings, etc.
May deliver basic level writing training to small groups or individuals within IQVIA and to external clients.
Provide input into the PCE team business and strategic development.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
Understanding and interest in health outcomes research principles, clinical outcomes assessments including PROs, ClinROs, ObsROs and PerfOs, and familiar with the literature.
Good understanding of common statistical methods used in clinical trials or pharmaceutical work and/or interpretation of their results. Familiar with qualitative research studies and quantitative studies for clinical outcome assessments (psychometrics).
Proven experience in the use of key literature databases (e.g., PubMed, Cochrane) and the conduct of literature reviews.
Proven scientific writing skills and ability to communicate fluently and effectively in English, both in writing and verbally.
Familiar with the structural and content requirements of patient-centered-endpoints related project deliverables particularly for those with an important scientific writing component (e.g., COA dossier, briefing book, etc.). Knowledge of regulatory COA-related guidance documents.
Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner and to present a line of argument and explanation as required in regulatory documents and publications.
Careful attention to detail and accuracy.
Demonstrated ability and experience to work independently on patient centered endpoints-related projects.
Must be computer literate with knowledge of Microsoft Office applications including Word, PowerPoint and Excel, Bibliographic software such as EndNote and of publication management software such as DatavisionTM or PubSTRAT.
Must be able to work in a fast-paced environment with demonstrated ability to effectively manage multiple tasks and projects.
Ability to coach and develop more junior members of the project teams on writing tasks
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Ability to identify deficiencies, errors, and inconsistencies in deliverables.
Confident and effective communication and negotiation skills with customers and project managers.
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
A minimum of a Master's degree or educational equivalent in in psychology, epidemiology, educational psychology, outcomes research, sociology, medicine, medical science or related field is required.
A minimum of 5 years relevant work experience including line management.
Strong communication skills.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
Extensive use of keyboard requiring repetitive motion of fingers.
Regular sitting for extended periods of time.
Travel as required.
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
IQVIA is an EEO Employer - Minorities/Females/Protected Veterans/Disabled
IQVIA, Inc. provides reasonable accommodations for applicants with disabilities. Applicants who require reasonable accommodation to submit an application for employment or otherwise participate in the application process should contact IQVIA’s Talent Acquisition team at firstname.lastname@example.org_ to arrange for such an accommodation.
At IQVIA, we have a vision. Where every healthcare decision is based on evidence. Where data science and human science come together to improve global health. Where new and creative solutions aren’t just possible – they are expected.
Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare. The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease. We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you’re supported to succeed.