Global Publishing Manager Regulatory Affairs
Global Publishing Manager Regulatory Affairs
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Job Description
The Role
The Regulatory Operations Global Publishing Manager is responsible for overseeing the planning creation and submission of regulatory submissions. In collaboration with the Regulatory Lead you will manage and prepare highquality global submissions both inhouse and via CROs ensuring timely delivery of compliant submissions to global health authorities. The Global Publishing Manager provides regulatory operations expertise to crossfunctional submission project teams promoting and ensuring excellence in the planning preparation and delivery of regulatory submissions. You will act as the primary point of contact for daily submissions for major submissions and lead a team of publishing specialists. At Moderna we act with urgency and behave like owners reflecting our commitment to delivering transformative medicines to patients.
Heres What Youll Do:
Compile publish and verify submission dossiers in accordance with international eCTD requirements.
Act as a team leader providing direction support and mentorship to the publishing team.
Oversee the compilation publishing and verification of submission dossiers in accordance with international eCTD requirements and regulatory guidelines.
Lead and manage the submission of MAA INDs NDAs BLAs Master Files and other regulatory documents.
Work closely with team members to compile documents review hypertext links ensure PDFs are submission ready format tables and graphics bookmark sections and proof submissions according to internal standards.
Develop and implement new processes and procedures to enhance efficiency and accuracy during the submission process.
Collaborate with submissions management to build technically valid and highquality dossiers.
Manage the submission of eCTD sequences through health authority gateways.
Perform quality control (QC) of documents published by team members to ensure compliance with applicable guidance documents.
Assist with the remediation of Word documents to ensure proper format and compliance.
Mentor and train team members to increase the quality across the team.
Participate in internal and external audits maintaining compliance with department systems e.g. project database timesheets training.
Contribute to the development of new publishing services and actively participate in department initiatives and process improvements.
Maintain a strong understanding of applicable regulatory guidelines and ensure the achievement of individual and team utilization targets.
Act as the primary point of contact for the team providing regular updates to senior management on project status and any issues affecting quality timelines and adherence to contractual obligations.
Heres What Youll Bring to the Table:
Bachelors degree or equivalent.
At least 5 years of experience as a regulatory Publisher in a pharmaceutical company or CRO with 2 years in a management role.
Experience leading the submission of MAA INDs NDAs BLAs Master Files etc. formatted according to international eCTD requirements.
Clinical report and global submission dossier publishing/compilation experience in the pharmaceutical or related industry.
Experience with electronic clinical document publishing standards/formats and global regulatory submission publishing standards/formats (e.g. eCTD EU CTR).
Working knowledge of publishing tools (e.g. DXC eCTD Xpress Veeva) global submission validation tools Document Management systems Toolbox HA electronic submission gateways IRIS CTIS MS Office tools.
Familiarity with global Clinical and Regulatory HA requirements (e.g. FDA ICH EMA MENA region CH MHRA).
Strong interpersonal and project management skills with experience working in a complex global crossfunctional organization.
Highly motivated organized and detailoriented team player.
Analytical thinker with excellent problemsolving skills and the ability to adapt to changing priorities and deadlines.
Ability to readily adjust to change in a fastpaced environment and multitask.
Positive attitude and ability to effectively collaborate with peers stakeholders and crossfunctional colleagues in a global team environment.
Strong technical skills.
Strong communication and business writing skills.
Fluency in English.
This role is based in our new LEEDcertified HQ in Cambridge MA and is expected to be in office 70 of the time with flexibility to work from home up to 30.
At Moderna we believe that when you feel your best you can do your best work. Thats why our US benefits and global wellbeing resources are designed to support youat work at home and everywhere in between.
- Bestinclass healthcare coverage plus a suite of voluntary benefit programs to support your unique needs
- A holistic approach to wellbeing with access to fitness mindfulness and mental health support
- Lifestyle Spending Accounts to personalize your wellbeing journey
- Family planning and adoption benefits
- Generous paid time off including vacation volunteer days sabbatical global recharge days and a discretionary yearend shutdown
- Savings and investment opportunities
- Locationspecific perks and extras
About Moderna
Since our founding in 2010 we have aspired to build the leading mRNA technology platform the infrastructure to reimagine how medicines are created and delivered and a worldclass team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission values and mindsets every day our people are the driving force behind our scientific progress and our culture. Together we are creating a culture of belonging and building an organization that cares deeply for our patients our employees the environment and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer a Fast Company Best Workplace for Innovators and a Great Place to Work in the U.S.
As we build our company we have always believed an inperson culture is critical to our success. Moderna champions the significant benefits of inoffice collaboration by embracing a 70/30 work model. This 70 inoffice structure helps to foster a culture rich in innovation teamwork and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn contribute and make a meaningful impact.
If you want to make a difference and join a team that is changing the future of medicine we invite you to visit modernatx/careers to learn more about our current opportunities.
Moderna is a smokefree alcoholfree and drugfree work environment.
Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day please apply!
Moderna is committed to equal employment opportunity and nondiscrimination for all employees and qualified applicants without regard to a persons race color sex gender identity or expression age religion national origin ancestry or citizenship ethnicity disability military or protected veteran status genetic information sexual orientation marital or familial status or any other personal characteristic protected under applicable law.
Moderna is an EVerify Employer in the United States. We consider qualified applicants regardless of criminal histories consistent with legal requirements.
Were focused on attracting retaining developing and advancing our employees. By cultivating a workplace that values diverse experiences backgrounds and ideas we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at . (EEO Employer)
#LIKF1Required Experience:
Exec
Employment Type
Full-Time
