Submissions Manager
Description
Who We Are
For more than two decades, going our own way has led to countless breakthroughs, bettering the lives of those suffering from rare genetic disease. In 1997 we were founded to make a big difference in small patient populations. Now we seek to make an even greater impact by applying the same science-driven, patient-forward approach that propelled our last 25 years of drug development to larger genetic disorders, as well as genetic subsets of more common conditions. Through our unparalleled expertise in genetics and molecular biology, we will continue to develop targeted therapies that address the root cause of the conditions we seek to treat. Applying our knowledge to make a transformative impact is not just a calling, but an obligation to those who will benefit most. The end goal has always been better lives and now we can reach more.
And the more people we reach, the more our impact can grow. We transform lives through genetic discovery.
Our Culture
Our desire to make a positive impact on our patients extends to our employees and BioMarin is committed to fostering an inclusive environment where every person feels seen, valued, and heard – so employees can thrive in all areas of their lives, in and outside of work. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with the ability to develop their long-term careers. Ultimately, we want to be an organization where people enjoy coming to work and take pride in our efforts to help patients.
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class or best-in-class therapeutics that provide meaningful advances to patients. Come join our team and make a meaningful impact on patients’ lives.
The Submissions Manager will manage submission and report content plans in multiple regions including US, international and global dossiers. In addition, Veeva RIM functional administration, oversight of technical support for users and submission development process training as needed.
KEY RESPONSIBILITIES: |
Submission Planning Leadership and Communication · Develop submission level content plans with the GRA lead, identifies submission deliverables and critical path · Develop report level content plans with the functional lead, identifies report deliverables and critical path · Provide guidance and address questions that team members may have during the team meetings or off-line regarding the use of Veeva RIM to manage their submission documents o Confirm compliance of submission documents with regards to uploading documents within Veeva RIM o Ensure operational excellence and efficiency through the ability to search and find documents, as well as expertise in the general use of Veeva RIM o Advise the submission teams to ensure compliance with the defined business processes and address any business process related questions on the end-to-end process o Provide expertise and support to ensure overall submission excellence and compliance through hypercare and system support activities · Oversee Regulatory technology and process development activities as needed o Manages updates to content plan templates, doc types and other Veeva RIM functional administrative activities o Monitors and updates the overall submission processes o Supports eDMS system updates to industry regulations that impact submission strategies and technologies · Develop and author training materials and lead efforts to implement training to ensure optimal use of processes, and tools related to regulatory submission activities. o Identify retraining of individuals, or updates to the training materials as needed Technical support · Oversee applications and systems support, systems training programs, and supporting development projects within Regulatory Affairs · Trouble shoot complex system user issues (such as interpreting technical validation errors) Additional Responsibilities · Stay abreast of new guidances released by health agencies and coach team members on interpretation as needed · Perform regulatory intelligence for information pertinent to Regulatory Operations and provide a preliminary assessment of impact of new or modified regulations and guidances Required Skills · Experience in managing regional submission activities for a major filing, (IND, BLA, NDA, sNDA, DMF, Amendments, CTA, ASEAN etc.). including the management of global submission timelines · Must be highly proficient in MS Office 365 (with an emphasis on MS Word) · Strong knowledge of eDMS and (Veeva). · Must have extensive experience with electronic submissions, specifically eCTD
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COMPETENCIES |
Decision Making and Problem Solving, including an understanding of decision-making models and methodology Influence, Cross-Functional Collaboration and Organizational Awareness, including demonstrating professional maturity, including understanding own strengths and receptivity to feedback Agility and Proactivity, including an ability to anticipate risks or issues to program or business and take the necessary steps to mitigate or address Leadership, such as skill in clearly communicating objectives, goals, and expectations to others Communication, including an ability to provide context and articulate key messages effectively and with appropriate level of detail Strategic Thinking and Planning, such an ability to set short-term and longer-term goals for individual objectives and task completion Health Agency Submission Regulations and Process, such as demonstrated ability to provide an assessment of impact of new or modified regulations and guidances on submission processes and the ability to anticipate technical filing issues based on guidances and emerging issues throughout the submission process and proposes solutions. Formatting and Publishing, able to prepare complex filings in accordance with departmental procedures independently and diagnose and resolve a majority of complex technical questions across different submission types Drug Development and Product Knowledge, such as demonstrated knowledge of basic milestone documentation that happens along the clinical development pathway and why it is important. Also being familiar with the key considerations associated with product development, particularly as they apply to the regulatory function (e.g. labels, indications, safety) |
CAREER DEVELOPMENT |
BioMarin offers comprehensive career development programming, including guidance, targeted training opportunities, and mentorship programming. A career development pathway for Regulatory Affairs has been defined and is available to employees of BioMarin. |
PEOPLE MANAGEMENT |
This particular position does not manage people. |
EDUCATION AND EXPERIENCE |
· Degree in health or life sciences, including chemistry, molecular biology, or similar. Masters/Bachelors acceptable with relevant experience · 2 + year experience with PhD; 4+ years with Masters, 6+ with bachelor’s degrees · Must have extensive experience with global electronic submissions, specifically eCTD. |
WORK ENVIRONMENT / PHYSICAL DEMANDS / TRAVEL |
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus. |
EQUIPMENT |
Computer work utilizing common business software programs and hardware solutions. |
CONTACTS |
Internal: Regulatory Affairs, Clinical Operations, Clinical Science, Pharmacovigilance, Biometrics, Development Sciences Quality (DSQ), Global Medical Affairs, Clinical Medical Writing External: Health Authorities, Industry experts, Vendors |
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law.