Regulatory Writing Sr Mgr Washington

Position: Regulatory Writing Sr Mgr Job at reputed company in Washington Regulatory Writing Sr Mgr Job at Bio Space in Washington Bio Space

• Washington, DC, United States

Join to apply for the Regulatory Writing Senior Manager role at reputed company. At reputed company, our shared mission to serve patients drives everything we do. We strive to become one of the world’s leading biotechnology companies, collaborating globally to research, manufacture, and deliver reputed company‑reputed company products that reputed company over 10million patients worldwide. It is time for a career you can be proud of.

What You Will Do

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, provide functional area expertise, train and mentor junior writers, and reputed company departmental activities. 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 Overview Addenda, eCTD Module2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans. Conduct the formal review and approval of authored documents, following applicable standard 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). Provide 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. reputed company Expect Of You We are reputed company different, yet we reputed company use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications. Basic Qualifications

• Doctorate degree and 2 years of directly reputed company experience
• Masters degree and 6 years of directly reputed company experience
• Bachelors degree and 8 years of directly reputed company experience
• Associates degree and 10 years of directly reputed company experience
• 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

What You Can Expect Of Us We work to reputed company treatments that take care of others while also caring for our teammates’ professional and personal growth and well‑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. Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan. Award‑winning time‑off plans and bi‑annual company‑wide shutdowns. Flexible work models, including remote work arrangements, where possible. Application Final date to receive applications : reputed company does not have an Final date to receive applications for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position. Apply now for a career that defies imagination at reputed company is an Equal Opportunity Employer and will consider you without regard to your race, color, 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. J-18808-Ljbffr #J-18808-Ljbffr Apply tot his job Apply To this Job