Sr. Medical Writer
Sr. Medical Writer (Randstad Contingent Worker)
This position will be fully remote and can be home-based from anywhere in the US. However, the work hours will align to EST time zone.
In this role, you will have the opportunity to:
The Sr. Medical Writer will primarily focus on and be responsible for authoring and maintaining Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Post-Market Clinical Follow-up Plans (PMCFPs) and Post-Market Clinical Follow-up Reports (PMCFRs). In addition, the Medical Writer may contribute toward or author other technical documents that support clinical and regulatory efforts of the company
You will be responsible for:
Responsible for Regulatory/Clinical writing assignments, Support the writing of CSRs, Protocols, IBs, Summaries of Safety and Efficacy, Responsible for the preparation of documents across all phases of clinical development, Contribute to clinical studies across several therapeutic areas. Responsible for the preparation of documents across all phases of clinical development, Contribute to clinical studies across several therapeutic areas, Assist with documentation for pre-submission and submission packages, as required. Develop, maintain and update templates for clinical documents including protocols, clinical study reports, investigational brochures, Integrated Summaries, literature reviews, and associated documents up to and including regulatory dossier to standardize the development process across disciplines. Collect data by interviewing technical and process specialists, researching written material, attending training and demonstrations, using products, and observing users. Independently synthesize and describe complex scientific data, and be well versed in scientific terminology, principles, and publishing standards. Generate documents that meet appropriate quality standard, to support formal verification and validation activities. Lead and implement changes to improve the collaborative document creation process.
To succeed in this role, you should have the following skills and experience:
Minimum 5 years professional experience in the applicable role.
Education: Bachelors/Masters in a scientific/technical discipline or equivalent; advance degree (M.S., Ph.D.) desired,
experience in pharmaceutical, biological, or medical device development
Experience writing regulatory submissions such as NDAs/INDs,BLAs
Strong knowledge of FDA, ICH, ands GCP guidelines, Regulatory/Clinical writing experience,
You will be a part of:
An organization that believes what you do every day can contribute to the innovative health technologies and solutions we develop that make a positive impact on billions of people every year. Including you. Because you will find when you work at Philips that your professional and personal lives often intersect in unexpected and fulfilling ways. It is our mission to improve people’s lives through meaningful innovation and we want you to play a central role in this by leading teams, driving projects, thinking strategically and inspiring colleagues from all over the world.
In return, we offer you:
Philips welcomes you to a challenging, innovative environment with great opportunities for you to explore and grow.
Quality is on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, groundbreaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role you will have an array of diverse career opportunities open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
Why work on a project at Philips?
If you’re looking for meaningful work and a chance to tackle complex challenges, broaden your skills and expertise and become an even more sought after professional, you’ll find all that and more with project work at Philips.
The Randstad companies are responsible for finding talent to provide services at Philips. If you are selected to provide services for Philips, you will be employed by Randstad and will not be an employee of Philips.