Medical writer job description

RQM+ is the largest medical device and diagnostics focused full-service regulatory and quality consulting firm in the world. We accelerate the success of medical device, IVD, and combination product companies by providing industry-leading regulatory and quality consulting solutions. We exist to promote economic growth through regional partnerships, provide a rewarding place to work, and improve our communities.

With over 500 team members globally, providing world-class consulting services in a remote capacity is nothing new for RQM+. We are dedicated to the highest levels of client service and employee satisfaction delivered with empathy, integrity, individual pride and company spirit.

We are seeking regulatory scientists/medical writers to support the development and creation of Clinical, Scientific, and Regulatory documents in accordance with procedures, European Medical Device Regulation, and US FDA requirements. This includes, conducting literature reviews, assisting and writing Clinical Evaluation Reports, analysis of product complaints and trends, collecting and analysing feedback from various sources to support the CER.
*PhD post doc candidates are encouraged to apply.

Responsibilities Preparing, writing, editing, and reviewing regulatory (e.g. Clinical Evaluation Reports (CERs), clinical data reports or summaries) documents. Performing literature reviews for specific medical devices. Strong medical and technical writing skills. Knowledge and understanding of proposed and current global regulations and guidance and the ability to relay the impact of such regulations and guidance internally and with our clients. Ensures documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7.1 Rev. 4). Knowledge of clinical research and regulatory requirements.
Requirements2+ years of experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and CER document creation.Or 3 - 5 year's industry experience in medical writing in the healthcare industry or academia or in a related area such as quality, regulatory, clinical research, or product support. Experience with FDA and international regulations, requirements and guidance associated with clinical regulatory document preparations, submissions and reporting preferred.Action-Oriented, Approachability, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning.

Being an industry leader in client support is just the beginning for RQM+. Providing a rewarding place to work is rooted deep in the core values of RQM+. From an industry leading compensation package to a deeply engrained focus on work life balance, RQM+ applies the “and means more” approach to employment. At RQM+, you are not just another employee, you are a member of the RQM+ family. Make your impact today!

We invite you to submit an application if you have an interest in learning more about our organization and beginning your journey as a consultant with us.

For more than 25 years, Veristat has built a reputation as a thoughtful partner in the clinical development and regulatory submission process. We have done so by hiring talented people who align to our core values and share a common passion for our mission driven work.

Do you value a collaborative work environment and the opportunity to truly make a difference? If so, you will feel right at home here. At Veristat, you can grow both personally and professionally, with opportunities to discuss your achievements and advance your career through quarterly feedback conversations and meaningful work.
We do things differently than large CROs and would love to have you join our Veristat team!


The Principal Medical Writer independently plans and prepares a variety of clinical documents necessary for all phases of clinical drug and device development by organizing, analyzing, and interpreting scientific and statistical data. Such documents include Module 2 clinical summaries of marketing applications, integrated summaries of safety and efficacy, clinical study reports, study protocols, investigator's brochures, aggregate safety reports, and manuscripts.

As a Principal Medical Writer You Will...


Conduct overall planning and writing of the clinical sections of global marketing applications and other regulatory documents. Develop timelines and resource plans for the clinical sections of a submission or for implementation of communication strategy. Review statistical analysis plans as required. Perform “peer” review of documents written by other medical writers as required. Mentor junior members of the Medical Writing department. Keep management informed on progress of documents and other project-related information. Assist management in projecting resources and perform administrative duties as requested. Work independently with the sponsor representative(s) with regard to document planning, review, revision, and finalization.
Documents are to be completed within a time period that supports project needs and deadlines. Furthermore, documents are to be of high quality and scientifically accurate, and are to reflect a consensus among team members that is acceptable to all appropriate reviewers. Documents must meet International Conference on Harmonisation (ICH) guidelines and company document standards unless required otherwise by client and agreed per procedure.


Experience + Requirements


Bachelor's Degree in a science or related field. Minimum of 8 to 10 years of medical writing experience in a CRO, pharmaceutical, or biotechnology setting. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case-by-case basis. Working knowledge of ICH and other regulatory guidelines required. The ability to accurately and clearly present clinical data; strong verbal, written, and interpersonal communication skills; and proficiency in Microsoft Word are required. Broad knowledge of global pharmaceutical regulatory requirements required, and experience in clinical research or other areas of the pharmaceutical industry preferred. Excellent regulatory writing skills (e.g., English usage) and a keen attention to detail also are required.



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Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision making process.

The Career Potential

Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That's something we can all take pride in as we take this journey together.

Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It's who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.
The Opportunity

As we continue to grow, we are seeking a Medical Writer in the Medical & Clinical Affairs department. Under supervision of the Sr. Manager, Scientific Collaborations, the Medical Writer is responsible for generating scientific and medical content including but not limited to white papers, journal articles, educational materials, Scientific Validity Reports, Clinical Performance Reports for In Vitro Diagnostic Regulation (IVDR), and study reports.

Position based in Raritan, NJ or Rochester, NY with the option to work remotely a certain percentage of time.

The Responsibilities
Liaise with internal stakeholders across multiple functions to create content that meets project objectives.Conduct literature searches and extract relevant information for inclusion in scientific writing.Extract key information from study reports to generate scientific articles, white papers, and/or journal manuscripts.Produce copy for websites and other media platforms that connects with health care professionals.Produce presentation content for internal and external scientific and/or medical education.Perform other work-related duties as assigned.

The Individual
BS/BA required in the field of life sciences. MS preferred.Knowledge of content in AMA Manual of Style. Medical Writer Certification through American Medical Writers Association (AMWA) or similar association required.5+ years of medical writing experience for the pharmaceutical, in vitro diagnostic, and/or medical device industries is required.Experience conducting scientific research.Ability to present content in a way that optimizes readership.Proven ability to combine scientific knowledge with excellent writing skills.Proven planning skills and ability to manage multiple projects and timelines simultaneously.Proven interpersonal, leadership, organizational and effective time management skills.Microsoft Office proficiency.Ability to work independently and within a cross-functional team environment to build solid and productive relationships.Minimal travel will be required.

EOE/AA Disability/Veteran

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