Principal Scientific Publisher FRD at Teva Pharmaceutical Industries Ltd. - Israel

Ambernath, maharashtra, India -

Full Time

Start Date

Immediate

Expiry Date

17 Jan, 26

Salary

0.0

Posted On

19 Oct, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Technical Writing, Pharmaceutical Research, Formulation R&D, Quality Assurance, Regulatory Compliance, Good Manufacturing Practices, Statistical Analysis, Documentation Management, Communication Skills, Attention to Detail, Problem Solving, Team Collaboration, Presentation Skills, Data Integrity, Project Management, Organization Skills

Industry

Pharmaceutical Manufacturing

Description

Who we are Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.The opportunity The Principal Scientific Publisher will be responsible for the preparation of consistent and high-quality technical documents related to Pharmaceutical Research and Development for Formulation related documents in accordance with Teva's standards. Execute all functions in accordance with current FDA regulations, ICH guide lines, USP methodologies, cGMPs and SOPs. Maintain open communication with R&D members to ensure timely delivery of high-quality documents independently with minimal supervision. How you’ll spend your day Preparation of documents and facilitation of documentation management in R&D while following established guidelines for correctness, completeness and clarity. Preparation of documents such as Manufacturing Batch Records, Study Protocol and Reports, Stability Protocols, Product Development Report, Quality Overall Summary, response to regulatory queries, based on the scientific input from the Formulation team. Knowledge of QBD & DOE is essential. Knowledge of shelf-life extrapolation and statistical analysis would be preferred. Preparation of high impact presentations including graphs and charts. Submission of documents for signatures and coordinating their flow, archival and retrieval to ensure timely flow and publish monthly performance metrics. Continuously improve documentation systems to increase efficiency and compliance with cGMP and/or other regulatory requirements. Perform other duties as assigned or delegated. Comply with FDA guidelines/Company Policies of Data Integrity. Your experience and qualifications Education: A minimum master’s degree (M.Pharm) or a PhD in Pharmacy is required. Industry Experience Required: A minimum of 12 to 15 years of Formulation R&D experience with solid oral dosage forms for regulated markets is required. Knowledge of other dosage forms will be an added advantage. Demonstrated knowledge and understanding of quality and regulatory guidance for SOD products for regulated market. Demonstrated knowledge and working understanding of basic concepts of Good Manufacturing Practices (GMP), regulatory documentation required. Knowledge, Skills and Abilities Communication Skills Communication skills with the ability to speak and write with clarity and structure. Fluency in English and Advanced technical writing abilities a must. Well versed with business, scientific communication platforms. Computer Skills Proficient skills level with using Microsoft applications, including Word, Excel, & PowerPoint. Other software knowledge related to statistical tools for data mapping / trending experience preferred but not required. Awareness, Adaptation and Facilitation of communication technology channels is preferred. Demonstrated computer literacy, including spreadsheets, structural drawings, databases, and communication packages preferably in a Windows environment. Other Skills Proficiency in English spelling, grammar and punctuation. Strong organization skills, attention to detail, and the ability to work in a team fast pace environment. Good documentation skills and working knowledge of technical writing principles and practices. Good subject knowledge and problem solving skills required. Attention to detail, and the ability to work within a team in a fast pace environment is desired Ability to work in a highly independent and self-directed work environment is desired. 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.

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Responsibilities

The Principal Scientific Publisher will prepare high-quality technical documents related to Pharmaceutical Research and Development, ensuring compliance with FDA regulations and Teva's standards. Responsibilities include document preparation, management, and continuous improvement of documentation systems.