Regulatory Writing Manager (Home-Based) - IQVIA MedTech
IQVIA MedTech specializes in Medical Device and In-Vitro Diagnostic (IVD) products. This focused expertise meets the growing needs of device manufacturers to justify product safety and effectiveness as well as reimbursement and adoption challenges due to increased scrutiny by regulators, end-users, and patients.
Acts as Lead Technical Regulatory Writer. Prepares, reviews, and coordinates the preparation of MedTech regulatory documents for either internal customers or external clients. Technical documents may be related to medical devices, combination products and in-vitro diagnostics (IVD) with content consistent to industry regulations and client specifications. Builds strong, lasting relationships with client teams.
Prepares assigned documents in accordance with IQVIA MedTech 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 client comments.
Provides written and verbal feedback to junior staff, and to clients when appropriate.
Keeps abreast of current medical and/or technical writing/regulatory knowledge, along with developments and advances in medical device/IVD 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.
• Will present on standard Technical 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 Technical Writing to other IQVIA groups.
• May act as Project Lead for a more complex but single 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 Writing tasks.
• May take on customer lead role or assist an established partnership lead in their role.
• May represent region on a Technical Writing initiative or cross-functional initiative.
• Facilitates and brainstorms the identification of new ideas. May represent Technical Writing at a general capabilities audit.
- Bachelor's Degree in life sciences related discipline or related field
- Master's Degree in life sciences related discipline or related field
- Ph.D. in life sciences related discipline or related field
-Typically requires at least 5 years of highly relevant experience and related competency levels
- Equivalent combination of education, experience and training
KNOWLEDGE, SKILLS AND ABILITIES:
Experience with FDA/EU MDR/ EU IVDR regulations and awareness of 21CFR812 (US), ISO14155 and ISO20916
In depth knowledge of medical device/IVD development.
At a minimum, in-depth knowledge of the structural and content requirements of clinical study synopsis, clinical evaluation reports (CER), product evaluation reports (PER), Post Market Clinical Follow-up (PMCF) Plan
Good understanding of systematic literature search and review methodology
Good understanding of statistical principles and of medical terminology across a range of therapeutic areas.
Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner
Ability to identify deficiencies, errors, and inconsistencies in a report or regulatory documents.
Significant experience as a lead writer in preparing key technical writing documentation, with consistently positive feedback from customers and colleagues
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 clients and internal team members.
Able to deliver difficult messages in constructive manner
Demonstrates initiative and sound judgement when faced with less familiar project/document situations or challenges
Demonstrated abilities in collaboration with others and independent thought
Demonstrates confidence and maturity in most routine technical writing situations
Demonstrates good judgement in requesting input from senior staff
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
Ability to effectively manage multiple tasks and projects
Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with colleagues and clients
Must be highly computer literate.
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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