Regulatory Operations Associate I Job in Gaithersburg 20878, Maryland Us

My company shares my
passion for helping to improve
human health around the world.”

 

“This is My MedImmune.”

Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc.

Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities…that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.

Title: Regulatory Operations Associate I

Location: Gaithersburg, MD –Corporate Headquarters

Req: 6064

 

Marjor Duties and Responisibilities:

Responsible for compilation of Regulatory Submission outlines and assembly of electronic and paper submisions

Use Insight Publisher and electronic document management tools to prepare regulatory submissions according

to regulatory requirements for paper and electronic submissions

QC electronic and paper submissions to ensure compliance with company and agency requirements

Maintain effective interactions with all contributors and responsible RA professional, to ensure timely delivery of

regulatory submissions

Provide expertise to product teams on the application of electronic and paper submission requirements to their

specific submissions

Manage regulatory files by overseeing the indexing and maintenance of electronic and paper documents

Provide regulatory searching expertise in support of Regulatory Affairs by performing complex search and

retrieval functions on the official regulatory repository or EDMS

Provide submission history information on all MedImmune products

Represent regulatory information area, when needed, in any submission related working groups that may need

their expertise to support submission activities

Support the regulatory staff and other functional areas by performing PDF checks and document cleaning to

produce submission-ready documents

Support the regulatory staff in submitting documentation to regulatory agencies, including the preparing,

copying and shipping activities required

Support Regulatory Affairs by indexing documents and filing within the Document Control Room (DCR)

QC archival documents for inclusion in regulatory submissions as needed

Adhere to official retention and archiving schedules for the DCR

Maintain document archival workflow, as it pertains to archiving and filing in DCR

Support Regulatory Affairs on all Due Diligence activities as required

Support the Legal department with discoveries, as they pertain to Regulatory issues

Responsible for quality control of all documents, both paper and electronic, prior to entering the Regulatory

Archives, to ensure accuracy and consistency

Responsible for the daily production and submission to Agencies of all maintenance dossiers e.g. Protocols,

Amendments, Safety Reports, Annual Reports, etc.

Support Patient Safety Department for storing Electronically submitted Safety Reports in TARDIS

Qualifications

Education:

Undergraduate degree (scientific discipline or computer science preferable) or

relevant experience with a minimum of 2 years of related experience.

 

Experience:

Three years of pharmaceutical/biotech industry experience with a minimum of 2 years of experience with

publishing electronic and paper regulatory submissions

Skilled in using desktop applications

Skilled in indexing Regulatory documents

Experience in organizing discovery processes

Good knowledge of indexing methods

Good understanding of regional Agency regulations and submission process..

 

Special Skills/Abilities:

Knowledge of the ICH and regional eCTD specifications.  

Strong technical skills

Excellent communication skills and organization skills required

Ability to manage multiple tasks, work well under pressure and tight timelines is essential.

Skilled in managing multi-project tasks

Must demonstrate the following job competencies: results orientation; thoroughness, critical information seeking,

concern for impact, concern for standards

 

 

Job Complexity:

Works on problems of diverse scope where analysis of situation or data requires evaluation of

identifiable factors

 

Supervision:

Manages and coordinates the archival/retention/storage of paper and electronic records for the

department

 

 

To apply online please click here:   http://www.candidatecare.com/srccsh/RTI.home?r=2000010370610d=medimmune.candidatecare.com

 

MedImmune is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.

 

MedImmune does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on MedImmune’s approved agency list. Unsolicited resumes or candidate information submitted to MedImmune by search/recruiting agencies not already on MedImmune’s approved agency list shall become the property of MedImmune and if the candidate is subsequently hired by MedImmune, MedImmune shall not owe any fee to the submitting agency.