1+ months

Regulatory Affiars Writer: Associate Director

Kelly Services
Indianapolis, IN 46202
**Direct Hire Opportunity for an Associate Director Oncology Regulatory Affairs Writer!** Company is creating new cancer therapies, such as targeted radioligands, a technology that hold significant promise to treat cancer.

**The desired candidate will have experience with Oncology writing including: FDA briefing books, requests for orphan designations, request for fast track, requests for breakthrough, pediatric plans, etc.**

The position will be working remotely with the anticipation of travel for team and client meetings. Currently, our employees are working remotely and located within the Eastern Time Zone. To work in synergy, the preference would be for candidate to be able to work within the Eastern Time Zone to accommodate team and client meetings.

**Job Duties Include:**

+ Responsible for providing advanced expertise and support to the Senior Directors and/or EVP of Regulatory in the development and preparation of regulatory documents such as briefing books, pediatric plans, applications for breakthrough, orphan, fast track designation in the US.

+ Lead the review and development of materials intended for submissions for marketing approvals in US and other countries as required.

+ Provide guidance to project team and work directly with CRO partners in identifying and ensuring compliance with requirements for responses to request for information after major submissions to globally (INDs/CTAs, NDAs/ANDAs).

+ Support and if requested lead interactions with cross functional teams assigned to the development of specific response documents submission materials and will partner with submission manager to ensuring the accuracy and quality of submission-ready documents.

+ Overall accountability for ensuring cross functional collaboration in the preparation of high-quality, accurate, clearly messaged, properly sourced regulatory documents.

+ Ensure accurate, timely and compliant development, review, approval and delivery of regulatory submissions.

+ Understand, interpret and share relevant guidance and where needed identify and or summarize other information sources (eg, scientific literature, study summaries, figures, tables, graphs, health authority minutes).

+ Present or summarize relevant regulatory precedent and data in compliance with current industry standards, agreed templates and/or regulatory requirements.

+ Support cross-functional team interactions to ensure quality and completeness of information to be presented.

+ Prepare templates (with instructions to authors), develop writing style guidelines and facilitate efficient team contributions to provision of requested/relevant data and information (compliant with relevant and current regulatory requirements).

+ Partner with submission managers, regulatory senior project manager and external publishers to ensure all regulatory electronic document deliverables are processed and compiled in alignment with timelines.

+ Coordinate the review, approval, QC, required in the production of regulatory projects.

+ Ensure aligned resolution of document content issues and questions arising during the writing process.

+ Understand/comply with appropriate conventions, proper grammar usage, and correct format requirements per relevant ICH and other guidance.

**Requirements include:**

+ Bachelors degree is required, advanced degree preferred.

+ **Experience with Oncology Regulatory Writing including: FDA briefing books, requests for orphan designations, request for fast track, requests for breakthrough, pediatric plans, etc.**

+ Minimum of 8 years of relevant industry experience in medical/regulatory writing in the healthcare industry or academia required.

+ Expertise in interpretation of guidance documents and should be able to work independently using materials from previous interactions with healthcare authorities, literature, and clinical documentation (protocols, IB, treatment guidelines) to ensure development of timely, accurate and complaint, responses.

+ American Medical Writing Association (AMWA) certification with a specialty in Pharmaceutical Writing is or equivalent training highly desirable.

+ Experience in working with collaborative, cross-functional teams. Specifically, regulatory writing experience addressing responses to health authorities request for nonclinical, clinical, CMC or pharmacovigilance/safety requests for information.

+ Understands global regulatory requirements for different phases of development and different regulatory pathways.

+ Working knowledge of statistical concepts and techniques.

+ Excellent written and oral communication skills.

+ Documented expertise in summarizing of scientific content including oncology.

+ Ability to prepare, summarize, review of quality check presentations intended for diverse stakeholders/ audience.

+ Demonstrated attention to detail and ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy.

+ Advanced knowledge of various regulations, requirements and guidelines relevant to regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations.

+ Knowledge and expertise with Common Technical Document content templates, electronic document management systems and information technology.

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **** **Science & Clinical?**

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worlds most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

**About Kelly** ****

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellys Human Resource Knowledge Center.
Kelly complies with the requirements of Californias state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.


Posted: 2022-07-20 Expires: 2022-10-01

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Regulatory Affiars Writer: Associate Director

Kelly Services
Indianapolis, IN 46202

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