Avania Senior Medical Writer in Massachusetts
Avania is a leading, global full-service contract research organization focused on the management of clinical studies for medical devices, IVDs, biologics, and device-drug combination products internationally. Avania supports products from the first-in-human phase through the post-market phase with the same customized approach. When you need to advance your medical technology, it takes Avania. Avania’s vision is to be your trusted global partner in the evolution of your medical technology from innovation to commercialization to improving patient health and well-being.
The Senior Medical Writer (SMW) is responsible for the composition and production of a wide range of different type of clinical investigation and clinical evaluation related documentation.
Plan and prepare a variety of clinical investigation and clinical evaluation documents necessary for all phases of medical technology development by organizing, analyzing, and interpreting scientific and statistical data. Such documents can include Clinical Investigation Plans, Clinical Investigation (Interim) Reports, Investigator Brochures, Clinical Evaluation Plans, Clinical Evaluation Reports, Post Market Clinical Follow-up Plans, Summaries of Safety and Clinical Performance, journal articles/manuscripts, operation manuals, and Patient Information Leaflets/Informed Consents.
Ensure all documents are well organized, (scientifically) accurate, consistent, and in compliance with applicable Standard Operating Procedures, guidelines and regulations.
Take ownership of the project and project team performance as a whole.
Complete documents within a time period that supports project needs and deadlines.
Review Statistical Analysis Plans, as required.
Perform tasks delegated by the Medical Writing Director.
Work independently with the sponsor representative(s) with regard to document planning, review, revision, and finalization.
Assist in giving collegial on-the-job training and instructions to MW level I and II staff.
Provide overall project management oversight on multi-department studies.
Direct team meetings, providing consistent reporting and updates to all applicable team members and management.
Provide up to date information and proactive communication with project teams on all subjects and site matters.
Ensure overall compliance with applicable departmental Standard Operating Procedures.
Ensure maintenance (and timely review) of departmental Standard Operating Procedures, where required.
Ensure maintenance of personal and project specific training records.
Support Quality Assurance (QA) in quality system processes (e.g. internal audits), where required.
Post-graduate experience in (para)medical life science, or equivalent training and experience in medical writing, systematic review and clinical data appraisal.
5 years’ experience in medical writing.
Demonstrated knowledge and experience in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management processes, and experience with common bio statistical methods is preferred
Experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and CER document creation is required
GCP-ICH-E6, FDA regulations and ISO 14155, 13485 and 9001 knowledge where applicable
Knowledge of regulatory regulations and guidelines on medical devices.
Excellent writing skills.
Proficient in the use of computer and software systems (Microsoft Word, Excel, PowerPoint, email).
Fluent in English, spoken and written.
Flexible, but focused and persistent.
Excellent interpersonal and communication skills (oral and written).
Output and detail orientated.
Strong organizational and time management skills.
Proactive and strong problem-solving skills
Project management skills such as the ability to coordinate assignments, complete assignments within established timelines, refined and independent problem-solving ability, and attention to detail.
Client oriented skills such as recognizing a clients’ interests and needs, being main point of contact, building relationships with clients, subcontractors, other Avania departments.
Ability to manage multiple projects concurrently.
Excellent analytical skills with ability to interpret scientific and medical data, e.g. trend signaling.
Capability to communicate technical concepts clearly, concisely, and understandably.
Ability to independently manage clients.
Ability to work with minimal supervision while producing high quality deliverables efficiently.
Ability to work with minimal supervision while adhering to budgets and signal and escalate budget overshoots early on.
Ability to supervise and mentor other Medical Writers.
Well outlined training program
The opportunity to work in(cross-functional) international teams
Career path opportunities for your grow within the company
A dynamic team
Various team activities
We look forward to receivingyour motivation and CV.