Gilead Sciences Careers Remote 20-25 An Hour @To Apply For this #Job #ClickNow ( Associate Director )
Association Name: Gilead Sciences
Name of Employment: Associate Director
Required Education: Graduate
Work Hour: 8 Hour
What Will Be The Salary: $20-30/Hour
Company Info: Gilead Sciences, Inc. is an American biopharmaceutical company headquartered in Foster City, California, that focuses on researching and developing antiviral drugs used in the treatment of HIV/AIDS, hepatitis B, hepatitis C, influenza, and COVID-19, including ledipasvir/sofosbuvir and sofosbuvir.
Gilead Sciences Careers Remote 20-25 An Hour @To Apply For this #Job #ClickNow ( Associate Director )
Job Description
You Will Act As A Regional Regulatory Lead For More Complex Or Multiple Products, Compounds, Indications, Or Projects In The Assigned Therapeutic Area. It Is Common For You To Be Given Multiple Products Or Projects To Manage, Manage And Manage At The Same Time. You Will Define Regulatory Strategy, Plans, And Objectives For Assigned Products Or Projects. You May Act As Global Regulatory Lead For Early Stage Or Other Programs. You Will Lead Regulatory Or Other Regulatory Project Teams And Represent Global TA Regulatory In Cross-Functional Core And Sub-Teams. You Will Generally Serve As Gilead’s Point Of Contact For Regulatory Authorities. You Will Oversee The Preparation And Maintenance Of Regulatory Submissions, Regulatory Labeling, And Packaging For Assigned Products Or Projects; Thoroughly Guide And Advise Other Colleagues And Monitor The Performance Of These Activities. You Will Also Play A Leadership Role In Ad Hoc Or Special Projects That Continually Improve Or Otherwise Expand Regulatory Affairs Capabilities.
Example Of Responsibility:
Represents Gilead In Dealings With Regulatory Authorities As Needed.
Makes A Key Contribution To The Continuous Development And Improvement Of Regulatory Strategies, Processes, Standards, Procedures, Effectiveness, And Capabilities. Represents Regulatory Affairs And May Serve As Regional Lead Or Global Regulatory Lead On Cross-Functional/Cross-Regional Regulatory Proposal Teams. Provides Strategic Advice And Leadership To Regulatory Affairs And Cross-Functional Leaders And Teams. May Participate In Other Sub-Teams (Eg, Study Management, Clinical, Nonclinical, Biomarker) Or Delegate To Other Colleagues And Supervise And Lead Their Participation In The Sub-Team.
- Defined The Regulatory Strategy For Various Gilead Products Or Projects. Proactively Identifies Regulatory Or Related Risks/Issues And Develops Mitigation And/Or Emergency Plans.
- Directs And Oversees The Preparation, Compilation And Timely Submission Of Regulatory Submissions That Require Cross-Functional Interactions For Commercial Or Research Products. Examples Include Meeting Requests, Notification Packets, Original Investigational New Drug (IND), IND Revisions, And Routine Submissions (Eg, Developmental Safety Update Reports/Dsurs, Investigator Brochures/IB Updates, Etc.).
- Manages And Approves Approval Of Regulatory Documents, Including Meeting Requests, Module 1 Documents For Original IND, Etc. Manages And Oversees Labeling, Packaging And Related Information Updates And Maintenance In Accordance With Product License For Assigned Products And Brands.
Critical Review Of Documents For Submission To Regulatory Authorities. May Have One Or More Direct Subordinates.
Provides Matrix Management And Leadership To Project Teams. Provides Accurate And Thorough Input And Recommendations Regarding Resource Plans Required To Complete Proprietary Deliverables. Track Resources To Ensure Compliance With Agreed Resource Allocations, Including Budgets. Ensure Own Work Complies With Established Procedures, Policies And Processes And Any Regulatory Or Other Requirements.
REQUIREMENTS:
We Are All Different, But We All Use Our Unique Contributions To Serve Patients. The Qualifications And Skills We Are Looking For In This Role Can Be Found Below.
- Education And Experience In The US
- PharmD/Ph.D. With 2+ Years Of Relevant Experience. MA / MS / MBA With 8+ Years Of Relevant Experience.
- BA/BS With 10+ Years Of Relevant Experience. Significant Regulatory, Quality, Compliance Or Related Experience In The Biopharmaceutical Industry.
- Proven Track Record Of Effectively Setting Up And Managing Regulatory Or Related Strategies To Successfully Close One Or More Products Or Key Markets. Experience And Proven Effectiveness In Working And Negotiating With Regulatory Authorities.
- Significant Experience Participating In Cross-Functional Projects And Teams With Responsibilities Related To Clinical Trials Or Other Drug Development Activities. Experience With Line Management (Direct Reports) A Plus.
- Demonstrated Ability To Effectively Delegate And Manage Others As Evidenced By Previous People Leadership Or Matrix Management Responsibilities.
Gilead Sciences Careers Remote 20-25 An Hour @To Apply For this #Job #ClickNow ( Associate Director )
How to do company verification
Verifying a company is an essential step before entering into any business relationships or transactions. Here are some steps you can take to verify a company:
- Check the company’s website: Look for information about the company, such as its address, phone number, and email. Check if the website looks professional and well-maintained. Companies that are serious about their business will have a professional-looking website.
- Check the company’s registration: Look for the company’s registration number and verify it with the relevant authorities. In the US, you can use the online database of the Secretary of State or the Corporation Commission in your state.
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- Verify references: Ask the company for references from their clients or partners. Contact these references to verify the company’s reputation and quality of work.
Gilead Sciences Careers Remote 20-25 An Hour @To Apply For this #Job #ClickNow ( Associate Director )
Representation in interviews refers to the importance of being mindful of how you present yourself and your identity during an interview process. This includes factors such as your race, ethnicity, gender, sexual orientation, religion, age, and any other aspects of your identity that could potentially influence the way you are perceived by the interviewer.
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Gilead Sciences Careers Remote 20-25 An Hour @To Apply For this #Job #ClickNow ( Associate Director )
