Senior Clinical Development Scientist/Medical Writer

Job Title

Senior Clinical Development Scientist/Medical Writer

Job Description

Philips Job Ad Template – Non-Sales, US

Senior Clinical Development Scientist/Medical Writer

The Senior Clinical Development Scientist Medical Writer hybrid role in our Ultrasound group will be responsible for a combination of clinical research and medical writing tasks mostly related to new product releases, Artificial Intelligence projects, among others.

Your role:

• Leading the development of evidence generation strategies for assigned projects, working within a cross-functional team, in line with the value proposition that addresses the evidence needs of all key stakeholders. Delivery of Clinical Development Plans, describing the plans for clinical evaluation, as per internal and external requirements (US,EU, China, etc).
• Working closely together with internal (project owners, regulatory, clinical study managers, statisticians, business leaders, etc.) and external (clinical consultants such as key opinion leaders and subject matter experts) stakeholders to ensure that studies yield well-founded conclusions.
• Design and development of study protocols in compliance with project standards, specifications and applicable regulatory guidelines (GCP, ICH, FDA, ISO, EU MDR). Manage and oversee study execution, analysis of results and generation of final study reports to support Philips regulatory clearances, claims, reimbursement, health economic outcomes and/or market access.
• Deliver assigned clinical programs, working in partnership with Clinical Operations. Lead the development and dissemination of evidence generated from clinical evaluation plans to deliver Clinical Evaluation Reports in accordance with EU and China requirements, Clinical Study Reports and Clinical Summaries, and manuscripts. Lead clinical evidence discussions with regulators (deficiency requests/FDA, Notified Bodies, etc), advisory boards, associations, and societies.
• Ensuring appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports (CSRs), Clinical Evaluation Reports (CERs), abstracts, peer-reviewed manuscripts, etc. Additionally, good understanding of EU regulations and experience writing MEDDEV 2.7.1 rev4 and MDR compliant Clinical Evaluation Reports (CERs), Post Market Clinical Follow-Ups (PMCFs), Investigator Brochures (IBs) documents is also desired.

You're the right fit if:

• You’ve acquired 7+ years of experience in clinical research/development function (medical devices strongly preferred). You have a strong scientific background and deep expertise in the development of clinical evaluation and research methodologies, including innovative clinical trial design and working knowledge of biostatistics.
• Your skills include deep understanding of global clinical evidence requirements, including regulatory paths, and deep knowledge and understanding of all applicable standards/regulations in clinical evidence generation and dissemination, including Good Clinical Practice (GCP), FDA requirements, EU MDR (ISO 14155, CFR Part 812, Med Dev 2.7.1 (rev 4)).
• You have a PhD or MD (preferred) or master’s degree required in a Biomedical Science area.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.
• You’re an excellent written and verbal communicator of peer-review publications, scientific materials and research results. You are able to write original scientific documents such as clinical study reports, regulatory filings, investigator brochures, clinical evaluation reports, post-market clinical follow-up reports, internal reports, and scientific publications. You work collaboratively in cross-functional teams, and lead without direct reporting authority. You have a proven track record in successfully developing and executing clinical evidence strategies for regulatory submissions, on-time within budget and in compliance with SOPs and regulations.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the compan