What are the responsibilities and job description for the Regulatory Operations Submissions Specialist position at Ionis Brand?
Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We are pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With five currently marketed medicines for serious diseases and an expansive late-stage pipeline, we continue to build upon our groundbreaking innovations in science and technology to provide greater value to patients; and we are well positioned financially to deliver on our strategic goals.
At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know our success is a direct result of the exceptional talent and dedication of our employees.
With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money, and energy into making our onsite and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.
We are building on our rich history, and believe our greatest achievements are ahead of us. We invite you to apply and join us if you’re passionate about the opportunity to have meaningful impact on patients in need, our employees, and our organization. Experience and contribute to our unique culture while you develop and expand your career!
REGULATORY OPERATIONS SUBMISSIONS SPECIALIST
SUMMARY:
The Submissions Specialist is responsible for the formatting (Word), publishing (PDF), eCTD compilation, review and dispatch of regulatory submissions to global Health Authorities within required timeframes. This is an individual contributor position, reporting to the Sr. Manager, Regulatory Operations.
RESPONSIBILITIES:
- Format MS Word documents using software template tools and established standards.
- Publish PDF submission documents using standards for electronic submissions.
- Compile eCTD submissions.
- Prepare regulatory submissions, ensuring timely submission of high quality, compliant and valid submissions to global health authorities within required timeframes.
- Collaborate with interdepartmental teams to ensure the submission portfolio is properly supported and work in a matrix environment to meet Ionis’ business needs.
- Stay current with new electronic submission and regulatory documentation practices issued from global health authorities.
- Contribute to new and updated processes and standards.
- Collaborate with other submission specialists within the Regulatory Operations team.
- Participate in validation testing of new and upgraded software.
- Responsible for the accuracy of information for submission metrics and registration information for senior management.
REQUIREMENTS:
- Extensive experience with MS Word to prepare technical documents
- Excellent oral and written communication skills.
- Demonstrated ability to be productive and successful in an intense work environment.
- Bachelor's degree or equivalent work experience.
- At least 1 years of experience in biotech industry is preferred.
- Experience with document management technology and electronic publishing software (e.g., Adobe, ISI Toolbox, Veeva Vault, etc.) is desirable.
Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS003686
Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits
Full Benefits Link: https://www.ionis.com/careers/working-at-ionis/#:~:text=our employee spotlight-,Benefits,-Employees are rewarded
The pay scale for this position is $60,061 to $79,424
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
Salary : $60,061 - $79,424
