Job Archives
Asst. manager(Regulatory Affairs)- Gurgaon – 5+ years exp
Job title | Asst. Manager - Regulatory Affairs - Gurgaon |
Reports to | Director |
- Providing high-quality CMC review of technical documentation for regulatory filings to European Medicinal Agency (EMA), UK MHRA, National Agencies of EU Member states, Canada, Australia for DDReg clients
- Running De-centralized Procedures, MRP and procedures for national filings in EU Members states, Health Canada, TGA Australia
- Actively contribute to the development and implementation of regulatory strategies, processes and timelines for EU/UK/Australia/ Canada and global approval.
- Prepares and compiles new CTDs, Variations (Major/Minor/Site Transfers) filings ensuring that they are in conformance with applicable regulatory guidelines and that the highest quality standards are met.
- Critically reviews documentation intended for submission to the above mentioned agencies, internal consistency, for consistency to relevant guidelines and to promote regulatory excellence.
- Demonstrate subject matter and area expertise.
- Collaborate with internal and external clients,
- Supporting and enabling effective and efficient communication that results in operational excellence.
- Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices.
- Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on agencies website.
- Monitor competitive regulatory practices, and actively review internal and external factors to mitigate potential problems.
- Ensure that draft labeling complies with all applicable regulations and guidelines
- Bachelor's or Master’s degree in Pharma with 5 years of Experience
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years’) or equivalent combination of education, training, & experience.
- Experience working in the pharmaceutical/CRO industry preferred
- Excellent technical data interpretation skills
- Strong project management skills
- Excellent interpersonal skills including problem solving
- Strong negotiation skills
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of global, regional, national and other document development guidelines
- In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
- Great judgment and decision-making skills
- Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
- Ability and desire to work in a team-oriented environment.
- Excellent written and verbal communication skills
- Highly proficient with Microsoft Word, PowerPoint and Excel.
- Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
- Possesses a collaborative, results-driven style.
- Flexible, Adaptive, Ability to work under pressure and provide quality outputs within tight timelines
Job Description Job title Asst. Manager – Regulatory Affairs – Gurgaon Reports to Director Job purpose To Manage Regulatory Affairs for EU/Canada/Australia Markets in compliance to ...
Content Writer (2+ Exp)- Gurgaon
Duties and responsibilities: • Develop content on regulatory affairs from related information available within company • Research pharma industry-related topics (combining online sources, interviews and studies) • Write clear marketing copy to promote our services • Plan and develop audience-oriented content for Case studies, Blogs, Reports, Website, Social media posts, Infographics, Brochure, Video Scripts, JDs, Flyers, Press Releases, etc. • Write blogs on key topics periodically. • Proficient in using documentation tools (MS Word, Adobe Acrobat Pro, MS Visio, and Adobe Photoshop) • Ability to understand requirements and deliver clear and concise quality documents. • Hands-on experience on various tools- content creation, monitoring, content analysis, Content enhancement, translation. • Proofreading content for errors and inconsistencies. • Creating compelling headlines and body copy that will capture the attention of the target audience • Create strong content that fulfils company standards and audience goals. • Utilize a variety of media forms; include images and charts. • Analize current content and make improvements, as necessary. • Update website content as needed Education & Experience: • Experience in pharma content writing would be preferable. • Bachelor's degree in Communications, Marketing, English, Life Sciences, Journalism, or related fields. • A portfolio of published articles. • Proven experience (2-5 years) in content writing, content marketing or copywriting. • Working knowledge of content management systems. • Proficient in all Microsoft Office applications. • Excellent writing and editing skills. • The ability to work in a fast-paced environment. • Good time-management skills. • Experience doing research using multiple sources • Familiarity with web publications • Ability to meet deadlines
Knowledge, Skills and Abilities:
• Excellent verbal and written communication skills; the ability to call, connect and interact with potential customers. • Persuasive and goal-oriented • Possesses an energetic, outgoing, and friendly demeanour • Self-motivated and self-directed • Able to multitask, prioritize, and manage time efficiently • Able to work accurately under stress and pressure to meet competing deadlines • Excellent analytical and time-management skills • Creative problem solver who thrives when presented with a challenge • Tenacity to handle rejection and continue on with a positive attitude when reaching next potential client. • Ability to work independently or as an active member of a team • Strong computer skills, including Microsoft Office Suite (Word, PowerPoint, Outlook, Excel) and CRM/Salesforce exp preferred Location: Gurugram (INDIA)
Job Description: Job title: Content Writer Reports to: Head Content & Digital Media Development Job purpose: To develop and enrich content for DDReg tools, websites & Social media with new...
Scientific Report Writer (2+ exp)- Gurgaon
- Research and monitor regulatory requirements, guidelines, and industry trends from agency websites
- Analize and interpret regulatory information in context and provide concise & accurate summary
- Prepare high-quality, accurate, and compliant regulatory intelligence
- Maintain up-to-date knowledge of global regulations & standards, and their implications
- Assist in the development of regulatory strategies.
- Ensure reports are delivered on time, meeting deadlines, and expectations
- Support regulation submissions as needed
- BSc/B. Pharm in related field (Life Sciences, Pharmacy, Regulatory Affairs, or similar discipline)
- 2+ years of experience in scientific report writing
- Robust research and analytical skills with the ability to process and communicate complex/technical information
- Exceptional English written and verbal communication skills
- Attention to detail and ability to work with highly technical and scientific content
- Time management and organizational skills, with the ability to prioritize tasks effectively
- Familiar with regulations and guidelines (i.e., US FDA, EMA, UK MHRA, ICH)
- Familiar with navigating through regulatory agency websites to search for relevant/applicable guidelines
- A certification in regulatory affairs is a plus
Job Description: Summary In this role, the candidate shall be responsible for researching, analysing, and summarizing complex regulatory information and translating it into insightful and compliant re...
Asst. Manager – Medical Writing – Gurgaon
Job title | Medical-Regulatory Writer – Assistant Manager |
Reports to | Director |
- Providing high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients.
- Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices.
- Demonstrate subject matter and therapeutic area expertise.
- Effectively manage medical writing projects to deliver quality products in agreed timelines.
- Collaborate with internal and external clients,
- Writing CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Safety Reports, Aggregate Reports and other reports
- Perform science review of aggregate reports produced by PV Associates
- Ensure that document output and processes comply with client specifications, templates and styles guidelines
- Attend project initiation meeting, collate project
- Maintain awareness of current regulatory guidance, medical information techniques and technology relating to clinical / regulatory documentation
- Maintain & update Aggregate Report Tracker and carry out cases reconciliation on periodic basis
- Supporting and enabling effective and efficient communication that results in operational excellence.
- Carry out detailed searches in regulatory agency websites like US FDA, EMA, PMDA, TGA, UKMHRA etc for safety alerts
- Mentor Associates on job skills, oversees or develops training plans or materials for safety associates, conducts training sessions, or otherwise trains new hires and enhances the skills of existing
- Master's degree in a Pharmacology/Pharmacy/Medicine with 5 years Experience
- Advanced degree preferred
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years’) or equivalent combination of education, training, & experience.
- Experience working in the pharmaceutical/CRO industry preferred
- Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
- Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
- Strong project management skills
- Excellent interpersonal skills including problem solving
- Strong negotiation skills
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of global, regional, national and other document development guidelines
- In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
- Great judgment and decision-making skills
- Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
- Ability and desire to work in a team-oriented environment.
- Excellent written and verbal communication skills
- Highly proficient with Microsoft Word, PowerPoint and Excel.
- Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
- Possesses a collaborative, results-driven style.
- Ability to work under pressure and provide quality outputs within tight timelines
Job Description Job title Medical-Regulatory Writer – Assistant Manager Reports to Director Job purpose To plan and Manage Medico-Regulatory Writing for Regulatory in compliance to applicable...
Associate – Medical Writing – Gurgaon
Job Description: Job title Medical Writer – Associate/Sr Associate Reports to Director Job purpose: To plan and Manage Medical Writing for Regulatory and Pharmacovigilance Verticals in compliance to...
Associate – Medical Writing – Mumbai
Job Description: Job title Medical Writer – Associate/Sr Associate Reports to Director Job purpose: To plan and Manage Medical Writing for Regulatory and Pharmacovigilance Verticals in compliance to...
Job Description: Job title Associate – Regulatory Affairs Reports to Senior Associate/Astt Manager/Manager – Regulatory Affairs Job purpose: To carry out Regulatory Review and Compilation of Techn...
Sr. Associate – Regulatory Affairs – Gurgaon
Job Description: Job title Associate – Regulatory Affairs Reports to Senior Associate/Astt Manager/Manager – Regulatory Affairs Job purpose: To carry out Regulatory Review and Compilation of Techn...
Sr. Associate – Regulatory Affairs – Mumbai Location
Job Description: Job title Associate – Regulatory Affairs Reports to Senior Associate/Astt Manager/Manager – Regulatory Affairs Job purpose: To carry out Regulatory Review and Compilation of Techn...
Asst. Manager- Medical Writing – Gurgaon
Job title | Medical-Regulatory Writer – Assistant Manager |
Reports to | Director |
- Providing high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts to internal and external clients.
- Providing technical consultation and provides substantive advice on strategy, regulations and industry best practices.
- Demonstrate subject matter and therapeutic area expertise.
- Effectively manage medical writing projects to deliver quality products in agreed timelines.
- Collaborate with internal and external clients,
- Writing CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Safety Reports, Aggregate Reports and other reports
- Perform science review of aggregate reports produced by PV Associates
- Ensure that document output and processes comply with client specifications, templates and styles guidelines
- Attend project initiation meeting, collate project
- Maintain awareness of current regulatory guidance, medical information techniques and technology relating to clinical / regulatory documentation
- Maintain & update Aggregate Report Tracker and carry out cases reconciliation on periodic basis
- Supporting and enabling effective and efficient communication that results in operational excellence.
- Carry out detailed searches in regulatory agency websites like US FDA, EMA, PMDA, TGA, UKMHRA etc for safety alerts
- Mentor Associates on job skills, oversees or develops training plans or materials for safety associates, conducts training sessions, or otherwise trains new hires and enhances the skills of existing
- Master's degree in a Pharmacology/Pharmacy/Medicine
- Advanced degree preferred
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years’) or equivalent combination of education, training, & experience.
- Experience working in the pharmaceutical/CRO industry preferred
- Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
- Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
- Strong project management skills
- Excellent interpersonal skills including problem solving
- Strong negotiation skills
- Excellent oral and written communication skills with strong presentation skills
- Significant knowledge of global, regional, national and other document development guidelines
- In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, communications, etc.
- Great judgment and decision-making skills
- Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)
- Ability and desire to work in a team-oriented environment.
- Excellent written and verbal communication skills
- Highly proficient with Microsoft Word, PowerPoint and Excel.
- Demonstrates ability to evaluate information and data with a defined, studied process and report results in a thoughtful, organized manner
- Possesses a collaborative, results-driven style.
- Ability to work under pressure and provide quality outputs within tight timelines
Job Description Job title Medical-Regulatory Writer – Assistant Manager Reports to Director Job purpose To plan and Manage Medico-Regulatory Writing for Regulatory in compliance to applicable...
Associate Medical Writer – Mumbai
Job Description: Job title Medical Writer – Associate/Sr Associate Reports to Director Job purpose: To plan and Manage Medical Writing for Regulatory and Pharmacovigilance Verticals in compliance to...