Job details
Job type full-time
Full job description
As part of parexel consulting, you will create and maximize value for clients throughout the product lifecycleYou will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.
In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areasPlus, as member of parexel consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careersJoin our team, and you will design solutions for the complexities of an ever-changing global marketplace.
Full time
Travel: yes
Glassdoor reviews and company rating
Success profile
Check out the top traits we`re looking for and see if you have the right mix.
Detail-oriented
Proactive
Problem-solver
Results-driven
Organized
Multi-tasker
Rewards
Global impact
We are one truly global team working together to propel each client´s journey ahead faster.
Balance
We value work-life balanceWe try and keep regular hours and an emphasis on life outside the office.
Collaboration
Work with industry leaders and subject matter experts.
Freedom
The ability to innovate, ask “what if” and try new solutions without fear of failure.
Variety
Opportunities to work on multiple accounts – never boring!
Management
Strong management with depth of experience working for global health authorities.
Are you an experienced regulatory publisher who is looking to combine your publishing expertise with your passion for delivering on time quality submissions? who is looking for an opportunity to partner with a client with innovative therapies and provide oversight to their submissions? who is looking for an opportunity work from home? who has superior interpersonal skills and enjoys establishing and maintaining internal and external relationships? who is savvy with insight publisher? and is looking for an opportunity work alongside some of the industry’s best? if you answered ‘yes’ to these questions, parexel consulting`s growing team has an excellent opportunity for you!
We currently have an amazing opportunity to join parexel`s consulting team as a senior regulatory affairs publishing associate.
In this role you will:
Manage the development and maintenance of a submission content plan, which includes a detailed list of all source submission content (documents, data, etc.) and tracks documents from authoring to approval, publishing and qc.
As a global submissions’ expert, ensure the project team has awareness and knowledge of e‑submissions (ectd, nees, etc.) and life cycle management concepts and communicates regional differences as appropriate within the context of global submission preparation.
Effectively communicate project status, issues, schedule and accomplishments to various management and stakeholder groups, as needed.
Provide operational oversight for the planning, preparation, publishing, validation and timely submission of assigned applications (ind, nda, maa, etc.), updates, amendments, and variations to global regulatory agencies.
Manage activities of the publishing related teams in preparation of high-quality submission packages and their timely delivery to health agencies assures the work of the entire team or work stream is delivered on time and that it meets client’s and parexel’s quality expectations; functions as the main client contact and ensures accurate project reporting is in place; ensures that appropriate risk identification and issue-escalation procedures are in place; ensures project specific training compliance of the project team; ensures and/or manages project financials including provision of accurate revenue forecast; and ensures that the project team understand and work to the scope of the contract.
Compile regulatory submissionsCoordinate distribution of submissions to all concerned parties within agreed upon timeframesManage submission and product life-cycle information.
Maintain technical expertise of regulatory requirements and ensures alignment with company processes and client requirements.
Act as a subject matter expert for insight and other systems as needed
Lead and manage special projects as needed.
Qualifications
To ensure success, you will have:
Bachelor’s degree in a scientific discipline or systems technology or equivalent
3-5 years of pharmaceutical experience working in a regulated, life science environment (pharmaceutical, biotechnology, cro, etc) with a focus on regulatory publishing
Advanced working knowledge of ectd publishing systems, edms technology, and related publishing toolsPrevious insight publisher experience is required and previous veeva exp is a plus.
Extensive knowledge of north american/global submission standards (fda, health canada, ema, ich, ectd, etc.) and industry trends for dossier preparation (inds, ctas, etc.)
Knowledge of cdisc (adam, send, sdtm)
A demonstrated ability to lead and/or collaborate with groups cross-functionally (regulatory, clinical, nonclinical, etc.)
Excellent document formatting/troubleshooting skills in ms word/pdf professional.
Ms powerpoint skills
Excellent interpersonal and intercultural communication skills, both written and verbal
Client-focused approach to work (quality)
Results orientation
Teamwork and collaboration skills
Consulting skills
Critical thinking and problem-solving skills
Proficiency in local language and extensive working knowledge of the english language
The ability to travel domestically and internationally up to 10-15%, when appropriate, may be required
Eeo disclaimer
Parexel is an equal opportunity employerQualified applicants will receive consideration for employment without regard to legally protected status, which in the us includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
