Overview
IQVIA provides scientific services spanning clinical trials, real world evidence, and consulting in all areas of the product lifecycle. The Patient Centered Solutions (PCS) Strategic & Scientific Research (SSR) team leads the industry in generating data to ensure that the patient voice is incorporated into the development and commercialization of biologics, pharmaceuticals, and non-drug interventions. We focus on understanding and meeting the needs of our clients (mostly pharmaceutical and biotech companies) through the application of broad consulting expertise and technical scientific knowledge to design scientifically rigorous research. This research is broad and includes qualitative (e.g., interviews, focus groups), quantitative (e.g., clinical outcome assessments [COAs], patient-reported outcomes [PROs], patient preference), and passive approaches (e.g., digital health technology tools) to understand patient, caregiver, and healthcare professional experiences and expectations of disease and treatment. To meet our clients’ expectations and retain the excellent reputation built over time, the IQVIA PCS team is committed to recruiting, training, and supporting driven individuals who have both consulting skills and life science skills that can be applied to PCS research activities. Individuals joining us are assured of a rewarding and progressive career in patient-focused research. You’ll have the opportunity to address challenging client issues across multiple geographies with a hands-on influence in developing and delivering solutions. We operate in a truly multi-cultural, collegial, and collaborative work environment that is rich in development and growth. Role & Responsibilities
The Manager of Regulatory Writing acts as the lead writer on projects intended for a regulatory audience, including those with multiple deliverables or components. Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs), industry standards, and client requirements as well as to the agreed timelines. Performs senior review of medical/regulatory writing deliverables including scientific meeting packages, COA evidence dossiers, and reports supporting patient-focused drug development (PFDD). Provides feedback and guidance to more junior staff. Negotiates timelines and discusses/resolves client comments. Maintains current knowledge of medical, technical writing, and regulatory requirements. The Manager of Regulatory Writing will be a committed individual who combines high emotional intelligence with excellent communication skills. He or she will thrive in a fast-paced environment, be comfortable managing competing priorities, and able to influence stakeholders. The environment is dynamic and ever-changing, moving at the pace of our clients’ needs; thus, the PCS Regulatory Writer will be expected to understand the sense of urgency that is synonymous with the business. The role requires operating under high pressure to resolve resourcing demands quickly, find creative solutions, and make autonomous decisions. As a Manager of Regulatory Writing within the PCS SSR team at IQVIA, responsibilities include:
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
IQVIA provides scientific services spanning clinical trials, real world evidence, and consulting in all areas of the product lifecycle. The Patient Centered Solutions (PCS) Strategic & Scientific Research (SSR) team leads the industry in generating data to ensure that the patient voice is incorporated into the development and commercialization of biologics, pharmaceuticals, and non-drug interventions. We focus on understanding and meeting the needs of our clients (mostly pharmaceutical and biotech companies) through the application of broad consulting expertise and technical scientific knowledge to design scientifically rigorous research. This research is broad and includes qualitative (e.g., interviews, focus groups), quantitative (e.g., clinical outcome assessments [COAs], patient-reported outcomes [PROs], patient preference), and passive approaches (e.g., digital health technology tools) to understand patient, caregiver, and healthcare professional experiences and expectations of disease and treatment. To meet our clients’ expectations and retain the excellent reputation built over time, the IQVIA PCS team is committed to recruiting, training, and supporting driven individuals who have both consulting skills and life science skills that can be applied to PCS research activities. Individuals joining us are assured of a rewarding and progressive career in patient-focused research. You’ll have the opportunity to address challenging client issues across multiple geographies with a hands-on influence in developing and delivering solutions. We operate in a truly multi-cultural, collegial, and collaborative work environment that is rich in development and growth. Role & Responsibilities
The Manager of Regulatory Writing acts as the lead writer on projects intended for a regulatory audience, including those with multiple deliverables or components. Prepares assigned documents in accordance with IQVIA Standard Operating Procedures (SOPs), industry standards, and client requirements as well as to the agreed timelines. Performs senior review of medical/regulatory writing deliverables including scientific meeting packages, COA evidence dossiers, and reports supporting patient-focused drug development (PFDD). Provides feedback and guidance to more junior staff. Negotiates timelines and discusses/resolves client comments. Maintains current knowledge of medical, technical writing, and regulatory requirements. The Manager of Regulatory Writing will be a committed individual who combines high emotional intelligence with excellent communication skills. He or she will thrive in a fast-paced environment, be comfortable managing competing priorities, and able to influence stakeholders. The environment is dynamic and ever-changing, moving at the pace of our clients’ needs; thus, the PCS Regulatory Writer will be expected to understand the sense of urgency that is synonymous with the business. The role requires operating under high pressure to resolve resourcing demands quickly, find creative solutions, and make autonomous decisions. As a Manager of Regulatory Writing within the PCS SSR team at IQVIA, responsibilities include:
- Write health authority meeting packages, COA evidence dossiers, and manuscripts.
- Take a leading role in preparing assigned documents, including, but not limited to, confirming the scope of the task, templates and specifications; negotiating and adhering to timelines; organizing document reviews; and communicating directly with the client.
- Plan and organize workload for assigned projects and tasks: identify project needs, track timelines and implement customer requests.
- Use experience and initiative to address new or complex document types and client requirements.
- Chair meetings, act as point of contact for escalations, and resolve conflicts.
- Support the development of regulatory strategies for patient-focused evidence generation and communication to health authorities.
- Participate in bid discussions.
- Prepare and deliver knowledge-sharing sessions for the global team.
- Propose, plan, and deliver training on PCS Regulatory Writing to other IQVIA groups and externally, as appropriate.
- Represent Regulatory Writing on cross-functional initiatives.
- Draft or maintain Regulatory Writing Standard Operating Procedures (SOPs) and templates.
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Bachelor's Degree in a life sciences-related discipline or a related field.
- At least 7 years of highly relevant experience with demonstrated competency.
- In-depth knowledge of the structural and content requirements of NDAs/MAAs, INDs, COA evidence dossiers, clinical study reports, protocols, and similar documents and ability to identify deficiencies, errors, and inconsistencies in documents.
- Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.
- Extensive experience in preparing regulatory documents independently to a consistently high standard, regardless of complexity or challenges, and willingness to learn and excel at new document types and client requirements.
- In-depth knowledge of drug development, medical writing, and associated regulations. Strong understanding of statistical principles and 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.
- Demonstrates initiative and sound judgement when faced with less familiar project/document situations or challenges.
- Demonstrated abilities in collaboration with others and independent thought.
- Demonstrated ability to influence others without having official authority.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients at a senior level.
- Experienced and effective in providing feedback and guidance to less experienced staff.
- Ability to effectively manage multiple tasks and projects.
- Demonstrated proficiency with MS Office Suite as well as relevant software and systems.
- A self-starting mindset with excellent team-based interpersonal skills with the ability to work independently with the full spectrum of our people.
- Strong commitment to quality.
- Bachelor’s degree (or equivalent) in life sciences-related discipline or a related field.
- At least 7 years of highly relevant medical/regulatory writing experience and related competency levels.
Vacancy posted 22 days ago
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