When our values align, there's no limit to what we can achieve.
Do you have a flair for Regulatory Writing?
If you love writing, have a passion for clinical and nonclinical regulatory strategy, have experience with biologics, and are looking for an opportunity that will allow you to continue to have the flexibility of working from home while gaining tremendous professional experience and working with some of the Industry’s BEST, then Parexel's Regulatory Consulting team has an amazing opportunity for you!
As a Clinical / Nonclinical Regulatory Writer, you will :
Be responsible for Regulatory technical writing to support development of clinical documents in accordance with ICH / E6 / GCP guidelines to support US submissions, clinical trial applications, and clinical consultation responses for multiple clients.
Qualifications :
RA professional with experience in clinical development that includes 4+ years experience writing clinical and nonclinical technical documents and a strong understanding of ICH / E6 / GCP guidelines.
Primarily seeking an experienced Clinical author to support FDA submissions :
New INDs
Pediatric Plans, Fast Track Applications, Breakthrough Therapy Applications, Orphan Drug Applications, responses to FDA requests, Meeting Request and Packages
NDA / BLA submissions
Ability to interpret data and advice from regulatory authorities objectively, often in the face of strongly held competing views.
Extensive experience of all phases of the drug development process in regulatory affairs, including projects with little or no precedence.
Extensive knowledge of being able to develop product / therapeutic knowledge in a new area.
Previous experience independently authoring clinical and nonclinical modules for FDA submissions to include experience authoring 2.
4, 2.5, 2.6, 2.6.2, 2.6.4, 2.6.6, 2.7, 2.7.3 and 2.7.4 is required. EU submissions experience is a plus.
Previous Biologics experience is required. Previous device experience is a plus.
Previous experience with oncology or rare disease products is a plus.
Bachelor’s, Master’s or PhD in science / biological or healthcare.
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
Contributors and Freelance Writers
Web Hosting Canada wants you to write for the WHC Blog! We are looking for Canadian entrepreneurs, technology enthusiasts, small business owners, website designers, developers and online marketers that have a knack for writing to share their interesting experiences and insights with us. If you curre...
VP/MD, Global Corporate & Multinational Client Service (Toronto OR US Location)
Builds a high-performance environment and implements a people strategy that attracts, retains, develops and motivates their team by fostering an inclusive work environment and using a coaching mindset and behaviors; communicating vison/values/business strategy; and managing succession and developmen...
Associate Director, Financial and Regulatory Reporting
Reporting to the Director, Financial and Regulatory Reporting, the opportunity is an Associate Director role within the Financial and Regulatory Reporting team primarily responsible for the financial reporting and regulatory reporting to a Regulatory Organization for certain legal entities within th...
Business Analyst, Regulatory Trade & Derivatives Reporting
The candidate will have to write business requirements documents, user acceptance testing and provide support for BAU issues once project changes have been implemented to production. On behalf of our client in the Banking Sector, PROCOM is looking for a Business Analyst - Regulatory Trade & Derivati...
Sr. Manager, Market Access & Business Development (Toronto ON, Vancouver BC or Calgary ALB - Canada)
The Senior Sales role works closely with a cross-functional team, including marketing, operations, medical education, and clinical departments, to strategize and implement projects that support clinical pathways for both patients and healthcare providers. Manager of Market Access & Business Developm...
Career Opportunities for Persons with Disabilities - Scientific, Regulatory & Health Sciences Inventory (BI, CH, SG-SRE, PC, EG, EC, NU, MD)
The job opportunity you have selected requires the Public Service Commission (PSC) to transfer you to the hiring organization's Web site or a service provider Web site they have selected to advertise this process. Select the link below to be transferred from the PSC's GC Jobs Web site and be directe...
Int. Technical Writer to review, test and edit products to ensure they are compliant with the Accessible Canada Act (ACA)
Review and editing presentation products, including PowerPoint, so that the reading order in each slide/page is logical and will support text-to-speech software. Reviewing, testing and editing products to support their use by different types and ranges of disability, as well as with different assist...
Analyst, Regulatory & Tax Reporting
Reporting to the Team Leader, Regulatory and Tax Reporting, this role will be responsible for the preparation and coordination of various reports and analysis to ensure the entities’ compliance with regulatory and tax reporting requirements. Capital forecast – Responsible for creating the base balan...
Registration Officer - Securities and Regulatory
Providing guidance and counsel to employees and branches on regulatory and licensing matters in accordance with department policy and procedures and regulatory requirements. Provide reporting and feedback to the Manager, Registration on licensed personnel and any correspondence with Regulators, comp...
Senior Manager, Financial & Regulatory Reporting – Financial Instruments and Securities Reporting
Identify, propose, implement, and test reporting solutions for new financial and regulatory reporting initiatives/projects through interpreting requirements, and working with subject matter experts such as Accounting Policy Group, Platform Financial Controllers, Product Controllers, and Finance IT. ...