Senior Medical Writer Bengaluru 3 - 5 years INR 5.0 - 7.0 Lacs P.A. Work from Office Full Time

Roles & Responsibilities Ensure on-time development and delivery of various sections of high-quality regulatory documents compliant with MEDDEV 2.7/1 Rev. 4. and MDR for Medical Devices across therapeutic areas Actively engage with internal stakeholders and cross-functional client business teams such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs Deliver solutions that are customized per client requirements in terms of language, content, format, and presentation Assist the Team Lead/Manager in the development of schedules to ensure timely delivery Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables Train and mentor junior members of the team on technical/process related aspects Conduct proofreading, editing, document formatting, review comment incorporation and document completion / approval activities Perform literature searches on various databases Screening, appraisal per pre-defined criteria, and summarization of articles Interpret and present data from device-specific technical documents such as User Manuals/Instructions for Use Summarize quantitative data from post-marketing surveillance Conduct editing, proofreading, document formatting, and other document completion/approval activities Education Bachelors Degree / Post Graduation in any relevant Life Sciences field. Masters Degree is preferred. Experience Publication experience in scientific journals preferable Minimum 3 years of experience in Medical Device Regulatory documentation Familiarity with the Life Sciences Industry, preferably Regulatory Services Hands on experience on CEP/ CER/ PMSR/PSUR process Experience in creating high quality deliverables for customers Experience in handling projects and engaging with multiple clients independently Experience of working on projects involving all devices classes from various Therapeutic Areas Technical/Functional Skills Knowledge of clinical evaluation and related documents and regulatory requirements Proficiency in comprehension of scientific data and medical terminology and efficiency in summarizing information from source documents and published literature Proficiency with Microsoft Office (Word, Excel, and Outlook) Hands on experience on presentation tools such as PowerPoint, Visio etc., and referencing tools such as Zotero, Endnote, etc. will be an added advantage Effective reviewing skills for review of work done by trainees/junior writers Non-Technical Skills Strong verbal and written communications skills Ability to work as part of a team A constant zeal towards learning and skill development Potential to multitask and work within timelines Ability to understand and deliver on customer requirements Mentoring skills to act as trainer/mentor for junior members of the team Personal Traits Positive Attitude Initiative and Commitment Detail Oriented Team player Focused and sincere Perseverance Competencies Basic English grammar, punctuation, and sentence construction Logical comprehension Knowledge of medical terminology Excellent Communication (Writing and Verbal) Quality focused mindset Good time management Good stakeholder management.

HR Manager bengaluru 8 - 11 years INR 8.0 - 11.0 Lacs P.A. Work from Office Full Time

Designation : Manager-HR Qualification(s) :MBA/PGDM HR Experience(s) Bachelors or masters degree in human resources,Business Administration, or a related field. 8-10 years of progressive HR Generalist experience , with a significant portion in the life sciences or a related regulated industry. Preferred fluency in Kannada (both written and spoken). Demonstrated experience in managing the full spectrum of HR functions. Thorough knowledge of Indian labor laws and regulations. Exceptional interpersonal and communication skills. Strong problem-solving and conflict-resolution abilities. High level of integrity and ability to handle confidential information with discretion. Soft Skills Excellent English written and verbal communication skills Good organizational, interpersonal and communication skills COMPETENCIES Technical Competencies HR Knowledge and Compliance: A deep understanding of the full employee lifecycle, including recruitment, onboarding, performance management, and offboarding. The candidate must have extensive knowledge of Indian labor laws, specifically those relevant to the life sciences industry. Systems Proficiency: The ability to effectively use HR Information Systems (HRIS) and other software for managing payroll, employee data, and reports. Data Analysis and Reporting: The skill to collect, analyze, and interpret HR-related data to provide actionable insights for decision-making. Behavioral Competencies Communication: Exceptional verbal and written communication skills are crucial, with mandatory fluency in Kannada to connect with the local workforce. This includes the ability to conduct effective interviews, resolve conflicts, and communicate policies clearly. Interpersonal Skills: The candidate must be approachable, empathetic, and discreet, building trust with employees at all levels. This is essential for managing sensitive employee relations and confidential information. Problem-Solving: The ability to identify issues, think critically, and develop fair and effective solutions for a variety of employee and operational challenges. Conflict Resolution: The skill to mediate disputes and handle disciplinary matters with professionalism and impartiality, ensuring a positive and respectful work environment. Strategic Competencies Business Acumen: The capacity to understand the company's business goals and align HR strategies to support them. This includes contributing to workforce planning and talent management.support them. This includes contributing to workforce planning and talent management. Proactive Approach: A forward-thinking mindset to anticipate HR needs and implement proactive solutions, rather than just reacting to issues as they arise. Organizational Skills: The ability to manage multiple priorities and deadlines effectively, overseeing various HR functions simultaneously. Leadership and Influence: While not a senior leadership role, the candidate should be able to guide managers and employees on HR best practices and influence a positive organizational culture. Personal Traits Empathy & compassion Integrity & discretion Approachability Objectivity & impartiality Resilience & composure Proactive nature Strong Ethical compass Adaptability Roles and Responsibilities India Payroll & Compliance Manage the end-to-end monthly payroll process for our India workforce, ensuring accuracy and timeliness. Ensure full compliance with all Indian labor laws and statutory regulations, including but not limited to PF, ESI, professional tax, and income tax. Act as the primary point of contact for all statutory audits and compliance-related queries in India. Employee Onboarding & Documentation Oversee the new hire onboarding process, ensuring a smooth and welcoming experience for all new employees, globally. Manage all pre-joining and post-joining documentation, including offer letters, background verification, and employee records. Ensure all employee files are complete, accurate, and up-to-date in both physical and digital formats. HRMS Management & HR Analytics Serve as the system administrator for our HRMS (DarwinBox), handling configuration, updates, and troubleshooting for our global employee base. Maintain the global employee database, ensuring all data is accurate and secure. Generate and analyze HR reports and analytics to provide insights on key HR metrics such as headcount, attrition, and diversity. Employee Engagement & Lifecycle Management Develop and implement global employee engagement initiatives to foster a positive and inclusive work culture. Manage the complete employee lifecycle, from hiring and onboarding to performance management and exit. Support managers and employees on a range of HR issues, providing guidance on policies and best practices. Compensation & Benefits Assist in the administration of global compensation and benefits programs, ensuring they are competitive and equitable. Conduct market research to stay informed on compensation trends and recommend adjustments as needed. Handle all benefits-related queries and support the enrollment process for employees. HR SOP & Process Improvement Develop, document, and maintain HR standard operating procedures (SOPs) to ensure consistency and efficiency across all HR functions. Identify opportunities to streamline and automate HR processes to improve efficiency and the employee experience. Employee Relations and Engagement: Serve as the primary point of contact for employee queries and concerns, providing guidance on HR policies and procedures. Resolve employee relations issues, including conflict resolution and disciplinary actions, in a fair and confidential manner. Promote a positive and inclusive work culture through various employee engagement initiatives. Conduct exit interviews and analyze feedback to identify areas for improvement. Facilitate effective internal communication to keep employees informed and engaged. Performance Management: Support the implementation and administration of the company's performance management system. Train managers and employees on performance review processes and goal setting. Assist in the development of performance improvement plans (PIPs) for underperforming employees. Ensure timely completion of performance appraisals and provide necessary support. HR Policy and Compliance: Ensure all HR policies and procedures are compliant with local, state, and national labor laws, especially those relevant to the life sciences sector. Maintain accurate and up-to-date employee records and HR databases. Stay informed about changes in labor legislation and industry best practices. Prepare and submit required HR reports to management. Strategic HR Partnership: Collaborate with senior management to align HR strategies with business goals. Provide data-driven insights to support decision-making on workforce planning, talent management, and organizational development. Participate in special HR projects as needed. Exit Management Conduct exit interviews to gather feedback and identify areas for improvement. Manage the offboarding process for exiting employees, including final settlement, asset recovery, and documentation. Ensure a respectful and professional departure experience.

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