Principal Scientific Publisher FRD

• 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 Tevas 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.

• 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.

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.

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.