Industry Pharmaceuticals, Cosmetics, Medical Devices, Food Supplement, Labeling and Scientific Communications Position Full Time, Permanent Division Pubrica Brand Reports to: Pubrica Business Head About Company Guires Group is a renowned global provider of services in advanced Contract Research, Data Science, Development, Pilot Manufacturing, Education, Consulting and outsourcing. Under our diverse brand portfolio, we are dedicated to facilitating the development of innovative products and solutions across diverse industries." Job Function We are seeking a highly qualified and strategic Manager/lead of Scientific Publication, Communication & Regulatory Affairs Operations with a strong background in global operations and delivery in Business Process Outsourcing (BPO), especially in the areas of Publication Management, Regulatory Affairs Program Management, and Business Development. This role requires expertise in MIS reports & Analytics, Planning and Leadership, Transition Management, Problem Solving & Decision Making, Personnel Management, Customer Relationship Management, Productivity and Efficiency Improvement, and Process Creation & Improvement. The ideal candidate will possess highly effective communication skills and the ability to present ideas and data clearly to various stakeholders, including senior-level executives. A demonstrated track record of quality decision-making and creative problem resolution impacting program/project direction is essential. The candidate should also exhibit the ability to effectively lead and manage projects of increasing scope and complexity and have familiarity with the role of other disciplines contributing to the overall drug and medical device development program. Work Schedule: Full Time, Monday to Saturday, 10:00a.m. to 7:00pm. Hours may vary on occasion, depending on workload. Second and Fourth Saturday Holiday. Work Location Chennai, Tamil Nadu. Req. Qualification: \xc2\xb7 Bachelor\xe2\x80\x99s degree in Life Sciences \xc2\xb7 PhD, PharmD, or other post-graduate degree. Req. Experience: \xc2\xb7 Extensive experience in global operations and delivery, particularly in Business Process Outsourcing (BPO).

• Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience specific to hiring area (e.g., neuroscience, oncology, cardiovascular, immunology or endocrine expertise).

\xc2\xb7 1+ years\xe2\x80\x99 experience leading medical writing projects. \xc2\xb7 1+ years\xe2\x80\x99 experience leading activities or components of a project to meet business, publication and regulatory submission needs. \xc2\xb7 1+ years\xe2\x80\x99 experience scientific or medical and regulatory writing, clinical trial documents/or publications experience specifically within the biotech and pharmaceutical industry \xc2\xb7 Demonstrated project management and time management skills.

• Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates).

Req. Knowledge and Skills: \xc2\xb7 Proven track record in Publication Management and Regulatory Affairs Program Management. \xc2\xb7 Strong business development skills. \xc2\xb7 Expertise in MIS reports & Analytics. \xc2\xb7 Exceptional planning and leadership abilities. \xc2\xb7 Demonstrated proficiency in transition management. \xc2\xb7 Outstanding problem-solving and decision-making skills. \xc2\xb7 Effective personnel management experience. \xc2\xb7 Demonstrated success in customer relationship management. \xc2\xb7 Ability to drive productivity and efficiency improvements. \xc2\xb7 Experience in process creation and improvement. \xc2\xb7 Exceptional communication skills, including the ability to present ideas and data clearly to senior-level stakeholders. \xc2\xb7 Creative problem-solving skills with a record of impactful decision-making. \xc2\xb7 Capability to lead and manage projects of increasing complexity. \xc2\xb7 Familiarity with the role of other disciplines contributing to drug development programs. Key Responsibilities \xc2\xb7 Strategic Business Development: Develop and execute strategies to enhance our Regulatory Affairs business units, including Publication, Research & Development, focusing on niche solutions and thought leadership. \xc2\xb7 Client Management: Act as the primary point of contact for multiple pharmaceutical and medical device clients, ensuring the successful delivery of scientific communication and Regulatory Affairs services. \xc2\xb7 Sales and Solutioning: Lead RFP responses, prospecting efforts, and client presentations, offering expert consulting and sales pitches within the regulatory affairs domain. \xc2\xb7 Functional Expertise: Provide expertise in Regulatory Affairs functions, including Regulatory Affairs Strategy CMC & Operations, Publishing & Submission, RIMS, Labeling & Artwork Management, Medical Writing, Scientific Communication, Publication, and Research & Development. \xc2\xb7 Manage projects and stakeholders. Lead the writing process, use project management skills to finish regulatory documents on time, and create and communicate realistic timelines. Identify and address potential issues, collaborate with teams and stakeholders for document development, and keep everyone informed about project status. \xc2\xb7 Content strategy and execution including document preparation development, and finalization/document management: Gather and analyze data from various sources to create a clear content strategy. Write, edit, and oversee regulatory documents for clinical development, ensuring accuracy. Lead authoring team meetings and coordinate reviews. Maintain consistency in data and negotiate timeline changes. Collaborate with experts and manage relationships with vendors when necessary. \xc2\xb7 Knowledge skill and development: Continuously enhance your expertise in your assigned therapeutic area, including diseases and compounds. Be flexible to handle various document types, therapeutic areas, and compounds as project demands shift. Stay current with regulatory and publication guidelines. Develop a comprehensive understanding of your compound, therapeutic area, and the external landscape, including competitors, to effectively contribute to clinical planning, submission strategies, and regulatory responses, while also staying updated with the latest literature. Continuously refine your scientific communication skills to align with audience requirements and technological advancements. \xc2\xb7 Knowledge sharing: Share technical knowledge with others through coaching, guidance, and answering questions. Be recognized as an expert in specific document development. Collaborate with colleagues from various areas to discover and share best practices. Identify opportunities for process enhancements and contribute to them. Demonstrate proficiency in using databases and document management systems, providing expertise in these tools. \xc2\xb7 Delivery Center Management: Establish and oversee delivery centers serving various geographies, managing multiple vendors and resources across different countries. \xc2\xb7 Technology Implementation: Drive the implementation of technology solutions for regulatory workflow optimization, including process workflow design, software tool integration, validation, testing, and training. \xc2\xb7 Change Management: Anticipate future changes and challenges in the regulatory landscape, organize teams effectively, allocate resources strategically, and motivate personnel. Continuously monitor and manage data and KPIs to ensure project success. Employer +91-9566269922 Job Types: Full-time, Permanent Salary: From \xe2\x82\xb915,000.00 per month Benefits:

• Cell phone reimbursement
• Internet reimbursement
• Leave encashment
• Provident Fund

Schedule:

• Day shift
• Fixed shift
• Morning shift

Supplemental pay types:

• Performance bonus

Work Location: In person