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Global Regulatory Operations, Publishing Senior Manager

Avanir Pharmaceuticals

This is a Contract position in Aliso Viejo, CA posted June 13, 2019.

Global Regulatory Operations, Publishing Senior ManagerGlobal Regulatory Operations contributes to regulatory strategic objectives for the company’s development and marketed products including compilation, execution, and management of global submissions, compliance with submissions requirements clinical trial and marketing applications, and business ownership and administration of electronic submission tools and document managements systems.

The Global Regulatory Operations, Publishing Senior Manager is an individual contributor responsible for supporting the preparation and submission of electronic regulatory filings (eCTD) in compliance with global health authority requirements.

The position will ensure timely and compliant submissions of the highest quality, including clinical trial and marketing applications, i.e.

CTAs, INDs, amendments, meeting briefing packages, annual reports, safety reports and registration submissions (NDA/NDS/MAAs).

This position requires hands-on abilities, proficiency in process planning, electronic assembly and understanding of regulatory publishing and electronic document management processes, formatting, and archiving of regulatory submissions.

Must have an eye for detail and a solid understanding of global submission requirements.Essential Job Functions:Responsible for the preparation, delivery and archiving of high quality global regulatory submissions in accordance with company standards and timelines.Ensure submissions and related documentation are prepared in eCTD format and in compliance with applicable health agency regulations and guidelines.Performance of high level formatting in both word and PDF files, including the creation of bookmarks/hyperlinks, file optimization, optical character recognition, etc.Review/validate submissions for compliance with technical requirements.Maintain submission scheduling calendar to allow timely completion of projects.Participate in submission team meetings, volunteering for action items and participating in issue resolution.Ensure the use of the style guide for regulatory submission documents, providing subject matter expertise for the formatting and of submission documents.Maintain the corporate style guide and templates; providing training in their use as needed.Advise on regional and technical requirements for submission documents and provide answers to technical questions for submissions as needed.Support the implementation of necessary regulatory publishing systems, including assistance with validations, qualifications and verifications of the systems.Troubleshoot and resolve some technical issues with business-critical systems applications.Maintain effective relationships with external publishing vendors/ contractors to help manage the regulatory submission workload.Contribute to process improvement initiatives.Maintain the files for electronic regulatory correspondence, ensuring that all communications are properly archived.Collaborate with regulatory colleagues to evaluate and optimize the effectiveness of current work processes and operational plans.Contribute to the preparation and implementation of publishing processes and standards, and the updating/creation of the respective departmental SOPs and Regulatory Operating guidelines.Stay current with relevant global regulatory submission requirements and publishing best practices, assessing emerging issues in global regulatory environment that affect the organization’s ability to advance its business objectives and works with internal key contacts on strategy execution.Maintain a performance and improvement culture.Perform other related duties as assigned.Assist with other regulatory activities and special projects, as needed.This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee.

Other duties, responsibilities and activities may change or be assigned at any time with or without notice.Education/Qualifications:Bachelor’s degree or equivalent combination of education and work experience7 years of experience in the pharmaceutical/biotechnology industry.12 years of in-depth Regulatory Operations experience in pharmaceutical and/or biotech product development.Experience supporting new publishing systems/tools, standards, and process efficiencies.Highly knowledgeable in CTD/eCTD structure and requirements and a solid understanding of submission requirements for submission types (i.e.

IND, CTA, NDA, NDS, MAA, DMF, PSUR, DSUR, etc.).Detailed knowledge of eCTD publishing systems, EDMS technology, and publishing softwareExperience managing EDMS, regulatory publishing systems, and tracking databases.Detailed knowledge of clinical and nonclinical data standards (ADaM, SDTM, SEND).Experience in publishing and compilation of eCTD submissions for US filings is required and experience publishing ex-US electronic submissions is highly desirable.

Thorough understanding of submission production from a technical perspective beginning with the initial preparation to the final dispatch of compliant modules 1 through 5.Strong knowledge of US and other major global (ICH, EU, Asian) regulatory requirements and standards.

Thorough and current understanding of appropriate regulations pertaining to regulatory and technical requirements for electronic documents and all types of submissions.Strong knowledge of Microsoft Office suite, Adobe Acrobat, Adobe Plug-Ins (i.e.

ISIToolbox), electronic document management systems, eCTD publishing tools, eCTD validation and viewing tools.Ability to multi-task in a very fast-paced environment, while paying close attention to detail, and following projects through to completion to meet deadlines.

Ability to work independently as well as work in a team environment with changing timelines and priorities.

Must be able to effectively collaborate with peers and comfortable working in a matrixed team.Excellent project management and organization skills is a must.Must be solutions oriented and pragmatic (with analytical thinking and problem-solving skills).Excellent communication skills (verbal and written) and interpersonal skills.Proficient in Microsoft products (Outlook, Word, Excel, PowerPoint)Physical Requirements:This position primarily works in an office environment.

It requires the ability to sit or stand for long periods of time and frequent walking.

Daily use of a computer, phone, office equipment and other computing and digital devices is required.

May be required to stand for extended periods when facilitating meetings or walking in the facilities.

Some local travel may be necessary, so the ability to travel by plane, operate a motor vehicle and maintain a valid Driver’s license and/or effectively navigate public transportation is required.

While performing the responsibilities of the job, the employee must be able to read and respond to interoffice communications as well as effectively participate in meetings.

The employee is often required to sit and use their hands and fingers, to lift up to 20 lbs., pull, push, carry, handle or feel.

The employee is required to carry, handle items, reach with arms and hands, to stoop, kneel, or crouch; talk or hear.

Mental demands may require prolonged concentration, reading comprehension, understanding and interpretation of concepts, ideas and philosophies.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods.

Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described unless such accommodations would cause Avanir an undue burden.Work Environment:While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter.

Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job unless such accommodations would cause Avanir an undue burden.

While performing the duties of this job, the employee is occasionally exposed to moving carts, mechanical equipment (copiers, computers, coffee machines) and vehicles.

May be subject to smells and odors.

The noise level in the work environment is usually quiet to moderate.

The passage of employees through the work area is average and normal.EEO Statement:As an equal opportunity employer, Avanir Pharmaceuticals is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by federal, state, or local law.

All Avanir Pharmaceuticals employees, officers, principles, agents, and representatives are expressly prohibited from engaging in unlawful discrimination.

Consistent with federal, state, and local requirements, Avanir Pharmaceuticals will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions or the job, unless doing so would create an undue hardship.Avanir Pharmaceuticals shall abide by the requirements of 41 CFR-60-300.5(a) and 60-741.5(a).

These regulations prohibit discrimination against qualified individuals on the basis of protected veteran status or disability, and require affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans and individuals with disabilities.Avanir Pharmaceuticals, Inc.

is a biopharmaceutical company focused on bringing innovative medicines to patients with central nervous system disorders of high unmet medical need.

As part of our commitment, we have extensively invested in our pipeline and are dedicated to advancing medicines that can substantially improve the lives of patients and their loved ones.

For more information about Avanir, please visit http://www.avanir.comAvanir is a subsidiary of Otsuka America, Inc.

(OAI), a holding company established in the U.S.

in 1989.

OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd.

The Otsuka Group employs approximately 42,000 people globally, and its products are available in more than 80 countries worldwide.

Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/enAvanir® is a trademark or registered trademark of Avanir Pharmaceuticals, Inc.

in the United States and other countries