Medical Writing Clinical Publisher

Who we are

The opportunity

The primary responsibilities of the Clinical Publisher (Clinical Publisher) are to ensure the accuracy and compliance of clinical documents including but not limited to clinical study protocols, clinical study reports, investigator's brochures, and summary modules for regulatory submissions. This position requires prior experience in clinical document publishing or regulatory submission publishing, advanced technical proficiency with Microsoft Word and Adobe Acrobat, and a strong understanding of global regulatory submission standards (ICH, FDA, EMA).

A Clinical Publisher in Global Regulatory Medical Writing (GRMW) Operations provides basic support to GRMW (and other departments as appropriate) in the production of submission-ready clinical documents in support of drug development, product registrations, and product marketing. The Clinical Publisher's responsibility includes assignment to initiatives and or other tasks and projects as directed. These may include:

• Formatting checks of documents and ensures that GRMW documentation developed by Medical Writers adheres to applicable regulatory guidelines and departmental standards.
• Leveraging the master template and add-in toolbar to ensure consistency within documents prepared by medical writing or external partners. The Clinical Publisher will be able to advise and provide guidance to medical writers regarding formatting issues as needed.
• Training on Teva internal standard processes and systems involved with electronic document management.

Work format: This position offers flexibility for remote work. However, a hybrid arrangement in our Parsippany, NJ or West Chester, PA offices is preferred to facilitate cross-functional collaboration.

How you’ll spend your day

• 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

Your experience and qualifications

• 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.

Compensation Data

The annual starting salary for this position is between $112,080 - $130,000.  Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate.

Enjoy a more rewarding choice

We offer a competitive benefits package, including:

• 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.

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Important Notice to Employment Agencies - Please Read Carefully

Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities.  All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.