Senior Medical Writer

Job Title

Senior Medical Writer

Job Description

Senior Medical Writer- Sleep & Respiratory Care

The Senior Medical Writer will be responsible for authoring and maintaining clinical and post-market documentation (CEPs, CERs, PMCFPs, and PMCFRs). This person may also contribute to our author other technical documents that support Clinical, Regulatory, Risk Management, or Post-Market Surveillance efforts (e.g., Clinical Evidence Strategies, Benefit-Risk Determinations, PSURs).

Your role:

• Contributing to and authoring clinical evaluation deliverables for new and sustaining products (CEPs, CERs, and PMCFP/Rs) according to MEDDEV 2.7.1, Rev. 4 and compliant to EU MDR. You will also contribute to Risk Management and Post-Market Surveillance function efforts, as needed.
• Responsible for compiling, appraising/analyzing, and synthesizing multiple types and sources of data (e.g., clinical study results, post-market surveillance data, risk assessments, published literature) to evaluate product safety and performance and to identify potential evidence gaps.
• Acquire/maintain thorough knowledge of business unit products, competitor devices, state-of-the-art, current clinical/market developments, literature review processes and the ability to keep current with relevant literature. Must also remain current with regulatory requirements as they relate to clinical evaluations and contributions to regulatory documents.
• Interaction with cross-functional teams to ensure compliance of the clinical evaluation for new products requiring CE Mark and ensuring compliance with internal policies and procedures.
• Must manage timelines and communication to ensure deliverables and milestones are met; comply with Good Documentation Practices to ensure quality and accuracy of document content and format; and prepare for and participate in audits, as needed.

You're the right fit if:

• You have experience in clinical research or healthcare experience strongly preferred; knowledge of sleep and respiratory care therapies preferred. You also have strong experience and skill in performing systematic searches of the medical/scientific literature using tools including Embase and PubMed, highly skilled with data extraction and related tools (e.g., Distiller, Zotero), and advanced knowledge and experience with international regulatory requirements, standards and guidance’s (EU 2017/745, MEDDEV 2.7.1 Rev 4, ISO 13485, ISO 14155, ISO 14971, applicable MDCGs).
• Your skills include high levels of comfort and experience working within GDP and knowledge of relevant writing styles (e.g., AMA) and good publication practices (e.g., ICMJE). Strong knowledge of clinical research methodology, including study design, outcomes and measures, and biostatistics is required; strong ability to identify, mitigate and escalate risks, and strong ability to meet prioritize and meet multiple project deadlines. You have excellent written English and oral communications skills with strong attention to detail related to consistency, grammar, syntax, and accuracy.
• You have a minimum of BS/BA in a scientific or medical discipline with at least 7 years of experience in clinical evaluation report writing in the medical device industry OR an advanced degree (MS, MA, MPH, PharmD, PhD, MD) strongly preferred with at least 2 years of direct experience in clinical evaluation report writing in the medical device industry.
• 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 a self-starter with an ability to learn quickly and self-educate on different medical device products and procedures; have strong project/timelines management skills and organizational skills, as well as a demonstrated to work and communicate effectively in a team environment including leading discussions and presenting to internal business and regulatory stakeholders.

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 company’s facilities. Field roles are most effectively done outside of the company’s main f