IQVIA Commercial GmbH & Co. OHG
Scientific Clinical Writing Manager, Medical Devices - IQVIA MedTech
Publiziert am: 10/10/21 | Stevenage | VollzeitJetzt bewerben
QVIA 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 MedTech Scientific Writer. Prepares, reviews, and coordinates the preparation of MedTech documents including Clinical Investigation Plans, Informed Consent Forms, Investigator Brochures and Clinical Investigation Reports for either internal customers or external clients. 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 internal colleagues and 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 all types of scientific writing deliverables. Negotiates timelines and discusses/resolves client comments.
Provides written and verbal feedback to more 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.
- Bachelor's Degree in life sciences/engineering related discipline or related field [Required]
- Master's Degree in life sciences/engineering related discipline or related field [Preferred]
- Ph.D. in life sciences/engineering related discipline or related field [Preferred]
- Typically requires at least 5 years of highly relevant experience and related competency levels [Required]
- Equivalent combination of education, experience and training
Knowledge, Skills And Abilities:
- Significant experience with FDA/EU MDR/ EU IVDR and/or 21CFR812 (US), ISO14155 and/or 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 investigation plans (CIP), investigator brochures (IB), informed consent forms (ICF) and clinical investigation reports (CIR)
- Good understanding of common 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
- Experience in providing feedback and guidance to more junior staff
- 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. Confidence in appropriately challenging the client when document quality or timelines are as risk
- 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.
60549 Frankfurt am Main