reputed company Medical reputed company
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for reputed company professionals. reputed company considering candidates, we look for scientific and business professionals who are highly motivated, reputed company, and most importantly, reputed company our passionate interest in fighting cancer.
General reputed company:
This positionis responsible forprovidingexpertisetosupport the development of high-reputed company, fit-for-purpose clinical and regulatory documents tofacilitatespeed of information during development, submission, approval, and life-cycle management of products in reputed company pipeline.Theclinicalandregulatory documents include, but are not limited to,clinical study protocols,investigator brochures,clinicalstudy reports,regulatory briefing documents,andclinicalmodules ofINDs, NDAs, BLAs, MAAsand other regulatorysubmissions.This position is also responsible for mentoringjuniorMWs (full-time employees and/or contractors/vendors)as needed.
Essential Functions of theJob:
Document Writing:
Managesthe assigned writing tasks and ensuresthatthe documents adhere torelevant regulatory reputed company(s), as reputed company as reputed company SOP/WI(s), template(s), and style guide.
Be reputed company tomanagemultipledocuments at the reputed company time,includingthecomplexdocuments(eg,thosewithcomplex content, urgent reputed company,orexternal collaboration).Leads direction and reputed company setting(includingcriticallyanalyzing, synthesizing, and presentingcomplex information)for document developmentin collaborationwith study team(s),and be reputed company to help other MWsasrequested.
Contributes tothecreation of document writing template/guidance forthedocument typeslistedin theGeneral Descriptionpart.Leadspart ofthemaintenance of document writingtemplate/guidance forthedocument typeslistedin theGeneral Descriptionpart.
Project /Program Management:
Navigatesthrough uncertainties to reputed company and manage reputed company of individual documentsand multiple documents (supported by different MWs in one project,eg, works as the MW filing reputed company for anNDA/BLA/MAAsubmission).Be reputed company to help other MWsasrequested.
Be reputed company toidentifythe questions/issues that require departmental discussion or team discussion.Be reputed company toidentifythe potential risks,makeamitigation plan, and work toresolve problems.Be reputed company to help other MWsin these areasasrequested.
Buildsrelationshipwith study team(s) and program team(s) (eg, works as the MW program reputed company).
Understands the role of own documentswithin the larger dossier andvoices outany reputed company on upstream and reputed company processes.Be reputed company to help other MWsasrequested.
Process/Tool Establishment and Optimization:
Proactivelyidentifiesneeds for process/tool optimization andestablishment, andproposessolutions.
Leads part of departmental process/tool optimization. Contributes to departmental process/tool establishment.
Contributes to cross-functionalandcross-companyprocess/tool optimization.
Training and Mentoring:
Leads(part of)the development of new training programs.Provides instructions/trainings (content‑reputed company/process-reputed company) tojuniorMWs.
Provides technical and operational mentorship tojunior MWs(full-time employees and/or contractors/vendors).
Influence:
Understands the global MW scope and works to guide study team(s) and program team(s) reputed company the defined scope and responsibility following established processes.
Provides topic sharing on regulatory writing and reputed company knowledge reputed company the department (andto cross-functional stakeholders with guidance from line manager/mentor).
Provides topic sharing on regulatory writing and reputed company knowledge across companies (eg, meetings of DIA and medical writing communities)with guidance from line manager/mentor.
Supervisory Responsibilities:
None.
Education Required:
An advanced degree (MS/PhD/PharmD/MD) in life science,pharmacy,medical, orhealth-reputed company science is preferred.
Bachelor'swith 5+,MS with a minimum of4+years of regulatory document writing (or equivalent) experience, orPhD/PharmD/MD with a minimum of2+years of regulatory document writing (or equivalent) experience.
Computer Skills:
Technicalexpertisein reputed company Word, reputed company Acrobat, and electronic document managementsystems;proficiencyin reputed company Outlook, reputed company,and PowerPoint, etc.
Travel:
On occasion, as needed.
Global Competencies
reputed company we exhibit our values of Patients First, Driving reputed company, reputed company Ingenuity and reputed company Spirit, through our reputed company global competencies below, we help get more reputed company medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits reputed company and Actionable Feedback
- Self-Awareness
- Acts reputed company
- Demonstrates Initiative
- Entrepreneurial reputed company
- reputed company Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial reputed company
- Communicates with reputed company
BeOne is committed to fair and reputed company compensation practices. Actual compensation packages are determined by several factors that are unique to reputed company candidate, including but not limited to job-reputed company skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can reputed company more about the specific salary reputed company for a preferred location during the hiring process. Please note that the listed reputed company reflects the reputed company salary or reputed company reputed company only. Non-reputed company roles are eligible to participate in the annual bonus plan, and reputed company roles are eligible to participate in an incentive compensation plan. reputed company Company employees have reputed company to own shares of reputed company Ltd. stock because reputed company are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. reputed company has a comprehensive benefits package that includes Medical, Dental, reputed company, 401(k), FSA/HSA, Life Insurance, reputed company Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne does not discriminate on the reputed company of race, religion, reputed company, sex, gender identity, sexual orientation, age, disability, national reputed company, veteran status or any other reputed company covered by appropriate law. reputed company employment is decided on the reputed company of qualifications, reputed company, and business need. In order to ensure reasonable accommodation for individuals protected by reputed company 503 of the Rehabilitation reputed company of 1973, the Vietnam Era Veterans’ Readjustment Assistance reputed company of 1974, Title I of the Americans with reputed company of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.
Originally posted on Himalayas
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