About the role

Clinical Publisher ensuring accuracy and compliance of clinical documents for regulatory submissions at Teva Pharmaceuticals. Requires expertise in clinical document publishing and regulatory standards.

Responsibilities

Publishes clinical and regulatory documents (protocols, IBs, DSURs, CSRs, summary documents, and others) in compliance with regulatory guidelines and internal SOPs
Ensures submission readiness of all clinical documentation through thorough technical QC (document navigation, hyperlinking, bookmarks, headers/footers, metadata, PDF compliance, etc.)
Checks document formatting to ensure consistency, accuracy, and adherence to corporate style guides and regulatory publishing standards.
Manages publishing of stand-alone documents and Clinical Study Reports (CSRs)
Document formatting requiring competence in Microsoft (MS) Word and Adobe Acrobat Professional and Plug-Ins
Manages all documents level projects, smaller scale publishing projects and submissions with assistance
Provides business support for Medical Writing systems such as Veeva, PleaseReview, SharePoint and others
Provides template, style guide, PleaseReview and other supportive training and expertise to medical writers
Has a good understanding of processes and systems involved with publishing of GRMW clinical documents
Performs administrative or other responsibilities
Participates in cross-functional submission planning meetings and collaborates closely with Regulatory Operations and Medical Writing teams to ensure alignment and efficiency
Contributes to process optimization, including template maintenance, development of process, and preparation/revision of SOPs and guidance documents

Bachelor’s degree in life sciences (or other related field)
Minimum of 2 years of experience in clinical document publishing or regulatory operations publishing within the pharmaceutical or biotech industry.
Working knowledge of ICH, FDA, and EMA requirements related to clinical documentation, global submission processes (e.g., IND, NDA, MAA) and eCTD submissions.
Excellent English, both written and spoken
Excellent attention to detail, organization, and communication skills.
Advanced proficiency in Microsoft Word (macros, templates, and complex formatting) and Adobe Acrobat Professional (including publishing plug-ins and validation tools).
Excellent organizational/planning and problem-solving skills at the product and program level.
Preferred: Experience using Veeva Vault as an electronic document management system (EDMS)
Familiarity with PleaseReview, SharePoint, and other collaborative authoring tools.
Experience developing or maintaining document templates and process documentation.

Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays.
Life and Disability Protection: Company paid Life and Disability insurance.
Additional benefits include, but not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.