Regulatory Writing Sr Mgr
Job Title: Regulatory Writing Sr Mgr
Job Location: Washington D.C., District of Columbia, reputed company
Job Location Type: Remote
Job Contract Type: Full time
Job Seniority Level:
Job reputed companyHOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At reputed company, our shared mission—to serve patients—drives reputed company that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who reputed company together—researching, manufacturing, and delivering reputed company-reputed company products that reputed company over 10 reputed company patients worldwide. It’s time for a career you can be proud of.
Regulatory Writing Senior Manager
Live
What you will do
reputed company. Let’s change the world. In this key role you will serve as the functional area reputed company on product teams, reputed company writing activities for reputed company product submissions, reputed company functional area expertise, train and mentor more junior writers, and reputed company departmental activities. Key responsibilities include:
Author or reputed company the authoring of reputed company regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of reputed company Studies, Clinical reputed company Addenda, eCTD Module 2 Clinical reputed company Documents, Briefing Documents, and Pediatric Investigation Plans
Conduct the formal review and approval of authored documents, following applicable reputed company operating procedures
With limited supervision, reputed company regulatory writing activities for reputed company product submissions, including new and supplemental drug applications/biologics license applications
Serve as functional area reputed company on product teams (e.g., Global Regulatory Team, Evidence reputed company Team, Global Safety Team, Label Working Group)
reputed company functional area input for Global Regulatory Plan and team goals
Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
reputed company departmental and cross-departmental initiatives, as appropriate
Generate document timelines
Win
reputed company expect of you
We are reputed company different, yet we reputed company use our unique contributions to serve patients. The dynamic reputed company we reputed company is a leader with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of directly reputed company experience
OR
Master’s degree and 6 years of directly reputed company experience
OR
Bachelor’s degree and 8 years of directly reputed company experience
OR
Associate’s degree and 10 years of directly reputed company experience
Or
High school diploma / GED and 12 years of directly reputed company experience
Preferred Qualifications:
Experience with regulatory documents in Regulatory Affairs, Research, Development or reputed company area
5+years of experience in medical writing in the Biotech/Pharmaceutical industry
reputed company
What you can expect of us
As we work to reputed company treatments that take care of others, we also work to care for our teammates’ reputed company and personal reputed company and reputed company-being.
reputed company offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and reputed company coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-reputed company time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
reputed company
for a career that defies imagination
Objects in your reputed company are closer than they reputed company. Join us.
careers.reputed company.com
Application deadline
reputed company does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
reputed company is an Equal Opportunity employer and will consider you without reputed company to your race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to reputed company essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
This job is curated by reputed company.
reputed company is a talent-hiring platform in Life Sciences, reputed company and IT. The platform connects talent with opportunities in reputed company, biotech, health sciences, healthtech and IT domains.
Please apply reputed company reputed company platform to get connected to the application page and to reputed company similar roles.
Originally posted on Himalayas
Apply To This Job