Associate Director, Regulatory Writer
POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.
TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.
Location of work
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, it is preferred that our applicants are working within the same Eastern Time Zone to accommodate team and client meetings.
Overview
Reporting to the EVP of Regulatory Affairs, the Associate Director Regulatory Writer is 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. The Associate Director should also be able to lead the review and development of materials intended for submissions for marketing approvals in US and other countries as required. Additionally, the Associate Director needs to 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). The Associate Director has 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. The Associate Director will 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.
Responsibilities
- 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).
- Partners 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
- Bachelor’s degree is required with significant relevant writing experience, advanced degree preferred
- American Medical Writing Association (AMWA) certification with a specialty in Pharmaceutical Writing is or equivalent training highly desirable
- Minimum of 8 years of relevant industry experience in medical/regulatory writing in the healthcare industry or academia required, or in a related area such as quality, regulatory, medical affairs, or product support/R&D.
- 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
- 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 guidances 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.
Key Stakeholders
- Regulatory Team members
- Cross Functional Team Leads (preclinical, clinical, CMC, quality, submissions, regulatory project management)
Why joining POINT today will be the right career move for you:
There is no shortage of demand for smart, qualified and hardworking people like yourself – and we strongly believe POINT is the right career move for you. Here is why:
- You will help establish and define an organization that will change the course of cancer therapies. and help thousands of people each year
- You will be challenged, and are expected to challenge us, as part of a results-oriented, high performance team, where everyone leaves their egos at the door and lets the best ideas win
- You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company
- Most importantly, you will spend everyday working on something important
If what we are saying resonates with you, please submit a resume.
Benefits
- Health Care Plan (Medical, Dental & Vision) - effective day 1
- Retirement Plan (401k)
- Income Protection Insurance – (Life AD&D, Short & Long-term disability) – 100% employer paid
- Voluntary Income Protection – Premiums paid by employee
- Paid Time Off (Vacation, Sick & Public Holidays)
- $500 fitness reimbursement per year
- $100 cell phone reimbursement per month
All applicants who are offered employment with POINT Biopharma will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with POINT Biopharma policy and state law.
POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.
TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.
Location of work
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, it is preferred that our applicants are working within the same Eastern Time Zone to accommodate team and client meetings.
Overview
Reporting to the EVP of Regulatory Affairs, the Associate Director Regulatory Writer is 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. The Associate Director should also be able to lead the review and development of materials intended for submissions for marketing approvals in US and other countries as required. Additionally, the Associate Director needs to 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). The Associate Director has 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. The Associate Director will 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.
Responsibilities
- 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).
- Partners 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
- Bachelor’s degree is required with significant relevant writing experience, advanced degree preferred
- American Medical Writing Association (AMWA) certification with a specialty in Pharmaceutical Writing is or equivalent training highly desirable
- Minimum of 8 years of relevant industry experience in medical/regulatory writing in the healthcare industry or academia required, or in a related area such as quality, regulatory, medical affairs, or product support/R&D.
- 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
- 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 guidances 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.
Key Stakeholders
- Regulatory Team members
- Cross Functional Team Leads (preclinical, clinical, CMC, quality, submissions, regulatory project management)
Why joining POINT today will be the right career move for you:
There is no shortage of demand for smart, qualified and hardworking people like yourself – and we strongly believe POINT is the right career move for you. Here is why:
- You will help establish and define an organization that will change the course of cancer therapies. and help thousands of people each year
- You will be challenged, and are expected to challenge us, as part of a results-oriented, high performance team, where everyone leaves their egos at the door and lets the best ideas win
- You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company
- Most importantly, you will spend everyday working on something important
If what we are saying resonates with you, please submit a resume.
Benefits
- Health Care Plan (Medical, Dental & Vision) - effective day 1
- Retirement Plan (401k)
- Income Protection Insurance – (Life AD&D, Short & Long-term disability) – 100% employer paid
- Voluntary Income Protection – Premiums paid by employee
- Paid Time Off (Vacation, Sick & Public Holidays)
- $500 fitness reimbursement per year
- $100 cell phone reimbursement per month
All applicants who are offered employment with POINT Biopharma will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with POINT Biopharma policy and state law.
POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
© 2020 RemoteJobs.store. Built using NextJS and Vercel.
Uses RemoteOK and Remotive APIs.