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 applicable regulations and guidelines. This position will assist with the review of CMS documentations, preparation and submission of eCTDs, Variations, site transfers and post approval gap analysis. This position will also provide support of the regulatory function through document management, electronic submission compilation and management, and other group management activities as required. Position will be required to work with Regulatory Affairs, Quality Assurance, Quality Control, Manufacturing, Research and Development groups of the client organization of DDReg.   Duties and responsibilities  

• 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

Education & Experience

• 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

Knowledge, Skills and Abilities  

• 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

  Other requirements As may be required from time to time – the incumbent may be required to working slots catering to different time zones   Direct reports 1-4 to start with. Location Gurgaon, Haryana (INDIA) Last date to submit the applications: 25.11.2023

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 blog posts, guides and marketing copy.

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: Summary In this role, the candidate shall be responsible for researching, analysing, and summarizing complex regulatory information and translating it into insightful and compliant reports. Responsibilities

• 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

Qualifications

• 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

Location Gurgaon (in-person)    

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 Regulatory Guidelines Duties and responsibilities

• 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

Education & Experience

• 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

Knowledge, Skills and Abilities

• 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

Other requirements As may be required from time to time – the incumbent may be required to working slots catering to different time zones Direct reports Nil Location: 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 applicable regulatory and Regulatory Guidelines Duties and responsibilities: • 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 brief. • 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 personnel. Education & Experience: • Master's degree in a Pharmacology/Pharmacy/Medicine with 2 years exerience • 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 Knowledge, Skills and Abilities • 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 Other requirements As may be required from time to time – the incumbent may be required to working slots catering to different time zones Direct reports: Nil Location: 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 applicable regulatory and Regulatory Guidelines Duties and responsibilities: • 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 brief. • 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 personnel. Education & Experience: • Master's degree in a Pharmacology/Pharmacy/Medicine with 2 years exerience • 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 Knowledge, Skills and Abilities • 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 Other requirements As may be required from time to time – the incumbent may be required to working slots catering to different time zones Direct reports: Nil Location: Mumbai

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 Technical documentation & dossiers for Various Markets in compliance to applicable regulations and guidelines. Duties and responsibilities: • Providing high-quality CMC review of technical documentation i.e CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Labelling documents, for regulatory filings in emerging markets, for DDReg clients • Assist in development of high quality dossier for various markets • Adequacy Review and Gap Analysis of Technical Documentation for Non-CTD/CTD dossier compilation. • Closure of comments with the cross functional team & review of additional data generated in response to review comments per country. • Compilation of Dossier. • Review of registration dossier (m1-m5) as per country specific regulatory requirements • Deficiencies response management from various authorities by coordinating stakeholders for getting documents and compilation and review of response and compile response to queries from the MOH. • Updation of the dossier as per the queries responded (inclusive of all countries) • Demonstrate subject matter and area expertise. • Collaborate with internal and external clients, • Supporting and enabling effective and efficient communication that results in operational excellence. • Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on regulatory agency websites Education & Experience: • Master’s degree in Pharma discipline with 2 years experience Knowledge, Skills and Abilities • 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 Other requirements As may be required from time to time – the incumbent may be required to working slots catering to different time zones Direct reports: 0 to start with Location: 1. Gurgaon 2. Mumbai

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 Technical documentation & dossiers for Various Markets in compliance to applicable regulations and guidelines. Duties and responsibilities: • Providing high-quality CMC review of technical documentation i.e CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Labelling documents, for regulatory filings in emerging markets, for DDReg clients • Assist in development of high quality dossier for various markets • Adequacy Review and Gap Analysis of Technical Documentation for Non-CTD/CTD dossier compilation. • Closure of comments with the cross functional team & review of additional data generated in response to review comments per country. • Compilation of Dossier. • Review of registration dossier (m1-m5) as per country specific regulatory requirements • Deficiencies response management from various authorities by coordinating stakeholders for getting documents and compilation and review of response and compile response to queries from the MOH. • Updation of the dossier as per the queries responded (inclusive of all countries) • Demonstrate subject matter and area expertise. • Collaborate with internal and external clients, • Supporting and enabling effective and efficient communication that results in operational excellence. • Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on regulatory agency websites Education & Experience: • Master’s degree in Pharma discipline Knowledge, Skills and Abilities • 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 Other requirements As may be required from time to time – the incumbent may be required to working slots catering to different time zones Direct reports: 0 to start with Location: 1. 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 Technical documentation & dossiers for Various Markets in compliance to applicable regulations and guidelines. Duties and responsibilities: • Providing high-quality CMC review of technical documentation i.e CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Labelling documents, for regulatory filings in emerging markets, for DDReg clients • Assist in development of high quality dossier for various markets • Adequacy Review and Gap Analysis of Technical Documentation for Non-CTD/CTD dossier compilation. • Closure of comments with the cross functional team & review of additional data generated in response to review comments per country. • Compilation of Dossier. • Review of registration dossier (m1-m5) as per country specific regulatory requirements • Deficiencies response management from various authorities by coordinating stakeholders for getting documents and compilation and review of response and compile response to queries from the MOH. • Updation of the dossier as per the queries responded (inclusive of all countries) • Demonstrate subject matter and area expertise. • Collaborate with internal and external clients, • Supporting and enabling effective and efficient communication that results in operational excellence. • Demonstrate high level knowledge of country regulations and regulatory guidelines as updated from time to time on regulatory agency websites Education & Experience: • Master’s degree in Pharma discipline Knowledge, Skills and Abilities • 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 Other requirements As may be required from time to time – the incumbent may be required to working slots catering to different time zones Direct reports: 0 to start with Location: Mumbai

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 Regulatory Guidelines Duties and responsibilities

• 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

Education & Experience

• 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

Knowledge, Skills and Abilities

• 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

Other requirements As may be required from time to time – the incumbent may be required to working slots catering to different time zones Direct reports Nil Location Mumbai/ 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 applicable regulatory and Regulatory Guidelines Duties and responsibilities: • 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 brief. • 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 personnel. Education & Experience: • 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 Knowledge, Skills and Abilities • 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 Other requirements As may be required from time to time – the incumbent may be required to working slots catering to different time zones Direct reports: Nil Location: Mumbai