Medical Writer

In this role, you have the opportunity to make life better
Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.

We are looking for 2 Medical Writers to join our Clinical Development team that supports our Patient Monitoring documentation needs.

You are responsible for

Authoring Clinical Evaluation documents for new products and maintain/update existing company CEPs, CERs, and PMCFP/Rs according to MEDDEV 2.7.1, Rev. 4 and compliant to EU MDR
Evaluating clinical evidence from clinical investigations, published literature, post-market surveillance, risk assessments and post-market clinical data, and be able to generate a report of these data
Analyzing post-market surveillance data and risk management data to ensure consistency and alignment in CER and PMCFR
Performing gap assessments of clinical documents for devices to ensure clinical documentation meets all regulatory requirements
Contributing toward post-market surveillance and risk management programs as requested
Remaining current with regulatory requirements as they relate to clinical evaluations and clinical contributions to regulatory documents.
Maintaining thorough knowledge of assigned products
Identifying appropriate sources of relevant data, interpreting, evaluating and incorporating information from various sources
Managing timelines and communication to ensure deliverables and milestones are met
Preparing for and participating in audits as needed
Interacting with internal and international teams (engineering/marketing/regulatory) to gather information and ensure compliance of the clinical evaluation for new products requiring CE Mark
Acquiring or possess in-depth knowledge of competitor devices, state-of-the-art, current clinical/market developments, literature review processes and the ability to keep abreast of current literature
Complying with Good Documentation Practices to ensure quality and accuracy of document content and format
Ensuring compliance with corporate (e.g. SOPs) and regulatory requirements (e.g. GCP and US and OUS guidelines).
Other duties as assigned

You are part of
Our Clinical Development – Hospital Patient Monitoring team and directly reports to the Senior Clinical Development Manager HPM.

To succeed in this role, you’ll need a customer-first attitude and the following

Advanced degree (Master's or PhD) in scientific or medical discipline with familiarity in clinical evaluation report writing in the medical device industry or in scientific writing
Knowledge and experience with Medical Devices Directive 93/42/EEC, MEDDEV 2.7.1 Rev 4 Clinical Evaluations, and MEDDEV 2.12-2 PMCF is a plus
Experience and skill performing systematic medical/scientific literature searches (PubMed, Google Scholar, etc.)
Knowledge of research methodology (including clinical investigation design and biostatistics) preferred
Excellent written and oral communications skills-- strong attention to detail related to consistency, grammar, syntax, and accuracy
Demonstrated ability to work in a team environment, including leading discussions and presenting to internal business and regulatory stakeholders
Ability to identify and mitigate or escalate risks; identify roles/individuals to involve for decision making within clinical evaluation assessment and report development
Project/timeline management skills and organizational skills
Ability to prioritize and manage multiple projects and adapt to change as needed
Self-starter attitude with ability to learn quickly and self-educate on different medical device products and procedures; ability to work independently with minimal supervision
Strong familiarity with Microsoft Office
Research or healthcare experience preferred
Knowledge and experience with EN ISO 14155 Clinical Investigations is a plus
Knowledge and experience with ISO14971 Risk Management is a plus

In return, we offer you
Sharpen your talents with new challenges in our dynamic organization. We offer a competitive salary, outstanding benefits and flexibility in a career with a positive and supportive atmosphere in which to develop your talents further.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.