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
The Regulatory Affairs Submission Specialist, manages complex submission projects involving multiple cross-functional teams. With input from the EVP Regulatory, Project Management and/or CRO project leads (where appropriate) the Submission Specialist establishes and maintains submission planners and associated timelines, facilitates tactical team meetings, and represents Regulatory on selected project team meetings, for assigned products. Individual is recognized as a discipline expert and resource in regulatory affairs.
Responsibilities
- In collaboration with project leads, manages and/or provides operational oversight to ensure timely, high quality regulatory submissions for ANDA and NDA. Actively contributes to the definition and buy in of project timelines and deliverables. Plans and negotiates publishing timelines with the teams and to ensure all required resources are available to meet agreed submission timelines.
- Effectively manages multiple projects and competing priorities.
- Acts as primary Submission Operations interface with project teams providing guidance and communication of established submission processes and standards.
- Communicates effectively verbally and in writing with diverse audiences and across various levels within the organization.
- Anticipates obstacles and develop solutions within the team.
- Actively contributes to the development of optimal business processes and practices
- within the department to ensure high levels of customer support and to achieve high quality submissions. Identifies opportunities for efficiencies, business process improvements and cost reductions.
- Demonstrates team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
- Position accountability/scope includes minimal supervision. Receives project assignments from manager but has responsibility for managing own projects. Reviews project progress with manager on a regular basis with direction provided on follow-up
- Provides recommendations on project decisions and direction. Identifies opportunities for process improvements or cost savings. May lead or participate on internal project teams to update business processes.
- Provides estimates of activities with budgetary impact
Requirements
- Preferred Education: Bachelor’s Degree with Regulatory Affairs, PMP and/or RAC certificates highly desirable
- Required Experience: 3 – 5 years pharmaceutical or industry related experience
- Experience working in a complex and matrix environment. Strong communication skills both oral and written
- Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing
Basic Requirements
- Two or more years experience publishing electronic submissions for a Regulatory Authority in a major region (e.g. FDA, EMA)
- Two or more years experience working with document management and publishing software and utilities
Preferred requirements:
- Knowledge of detailed eCTD submission requirements in multiple regions.
- Ability to present and actively communicate electronic submission requirements and processes and champion change, both within Global Regulatory Affairs and with key stakeholder groups in R&D
- Ability to interpret published external guidance and advise on how to handle internal issues, and respond to technical questions from regulators
Competencies
- Demonstrates excellence in project/program management, including scenario planning, risk assessment and contingency planning
- Ability to work independently, while being a collaborative team member in a dynamic fast-paced and lean environment
- Expert proficiency in Excel, Word, and submission/publishing software (required)
- Ability to quickly adapt to new tools, frameworks, and processes; and adopt these for ongoing projects
- Organized with high attention to detail, accuracy and completeness
- Motivated to learn or advance own expertise and value. Positive self starter, who takes initiative, has the ability to multi-task and thrives under pressure (organizing and completing detailed tasks, checking accuracy and completeness of information)
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 cover letter and 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
The Regulatory Affairs Submission Specialist, manages complex submission projects involving multiple cross-functional teams. With input from the EVP Regulatory, Project Management and/or CRO project leads (where appropriate) the Submission Specialist establishes and maintains submission planners and associated timelines, facilitates tactical team meetings, and represents Regulatory on selected project team meetings, for assigned products. Individual is recognized as a discipline expert and resource in regulatory affairs.
Responsibilities
- In collaboration with project leads, manages and/or provides operational oversight to ensure timely, high quality regulatory submissions for ANDA and NDA. Actively contributes to the definition and buy in of project timelines and deliverables. Plans and negotiates publishing timelines with the teams and to ensure all required resources are available to meet agreed submission timelines.
- Effectively manages multiple projects and competing priorities.
- Acts as primary Submission Operations interface with project teams providing guidance and communication of established submission processes and standards.
- Communicates effectively verbally and in writing with diverse audiences and across various levels within the organization.
- Anticipates obstacles and develop solutions within the team.
- Actively contributes to the development of optimal business processes and practices
- within the department to ensure high levels of customer support and to achieve high quality submissions. Identifies opportunities for efficiencies, business process improvements and cost reductions.
- Demonstrates team leadership skills and ability to influence without direct authority. Builds and maintains positive relationships internally and externally.
- Position accountability/scope includes minimal supervision. Receives project assignments from manager but has responsibility for managing own projects. Reviews project progress with manager on a regular basis with direction provided on follow-up
- Provides recommendations on project decisions and direction. Identifies opportunities for process improvements or cost savings. May lead or participate on internal project teams to update business processes.
- Provides estimates of activities with budgetary impact
Requirements
- Preferred Education: Bachelor’s Degree with Regulatory Affairs, PMP and/or RAC certificates highly desirable
- Required Experience: 3 – 5 years pharmaceutical or industry related experience
- Experience working in a complex and matrix environment. Strong communication skills both oral and written
- Experience in Regulatory Operations, including regulatory submission project management and/or submission publishing
Basic Requirements
- Two or more years experience publishing electronic submissions for a Regulatory Authority in a major region (e.g. FDA, EMA)
- Two or more years experience working with document management and publishing software and utilities
Preferred requirements:
- Knowledge of detailed eCTD submission requirements in multiple regions.
- Ability to present and actively communicate electronic submission requirements and processes and champion change, both within Global Regulatory Affairs and with key stakeholder groups in R&D
- Ability to interpret published external guidance and advise on how to handle internal issues, and respond to technical questions from regulators
Competencies
- Demonstrates excellence in project/program management, including scenario planning, risk assessment and contingency planning
- Ability to work independently, while being a collaborative team member in a dynamic fast-paced and lean environment
- Expert proficiency in Excel, Word, and submission/publishing software (required)
- Ability to quickly adapt to new tools, frameworks, and processes; and adopt these for ongoing projects
- Organized with high attention to detail, accuracy and completeness
- Motivated to learn or advance own expertise and value. Positive self starter, who takes initiative, has the ability to multi-task and thrives under pressure (organizing and completing detailed tasks, checking accuracy and completeness of information)
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 cover letter and 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.
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