543 Medical Writing Jobs - Page 12

Description. Regulatory Associate. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Essential Functions. Assists with preparation of product development documents including gap analyses and clinical development plans.. Assists with preparation of regulatory submission documents including components of investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities, according to current government regulations and guidelines.. Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests.. Performs quality checks on related documents.. Assists with submissions of other regulatory documents and other regulatory research as needed.. Assists clients, customers, or others with general information. Gathers, compiles, analyzes, and reports information.. Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence.. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Summary. Under supervision, supports regulatory agency submissions, regulatory research, and product development. Responsibilities typically include the creation of submission documents to support investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities.. Show more Show less

Description. Sr Medical Writer (CTT). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Mentors and leads less experienced medical writers on complex projects, as necessary.. Acts as lead for assigned writing projects.. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. -Develops or supports a variety of documents that include, but not limited to:. Clinical study protocols and clinical protocol amendments;. Clinical study reports;. Patient narratives;. Clinical development plans;. IND submissions and annual reports;. Integrated summary reports;. NDA and (e)CTD submissions;. Investigator brochures, as well as;. Clinical journal manuscripts, clinical journal abstracts, and client presentations.. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.. Serves as peer reviewer on internal review team providing review commentson draft and final documents.. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.. Performs on-line clinical literature searches, as applicable.. Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.. Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.. Completes required administrated tasks within the specified timeframes.. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Trial transparency deliverables, protocol registration, protocol maintenance task, result posting for(CT.gov and EudraCT). Redaction of protocol and SAP (Statistical Analysis Plan). Qualifications. Minimum 7 years of experience in Medical Writing and atleast 5+ years of experience in Clinical Trial Transparency(CTT). Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.. Strong proficiency in Word, Excel, PowerPoint, email, and Internet.. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Summary. Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. This includes special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. The role involves screening, analyzing, and summarizing additional data from other sources as needed, conducting systematic literature searches and reviews, preparing literature for new products, and revising existing medical communication. These roles review and analyze statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through the preparation of briefing books and response documents to health authority questions. They may be responsible for entire projects or processes within their area of responsibility. Impact and Contribution Roles within the Medical Writing job family at the P22 level play a crucial role in ensuring the clear and accurate completion of medical writing deliverables, presenting scientific information clearly and accurately. They manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. These roles lead the resolution of comments from clients and complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings. They adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides. These roles coordinate quality and editorial reviews, ensure source documentation is managed appropriately, and act as peer reviewers for the internal team to ensure document scientific content, clarity, overall consistency, and proper format. Core Focus. Leading the clear and accurate completion of medical writing deliverables. Managing medical writing activities associated with individual studies. Coordinating these activities within and across departments. Completing a variety of documents, adhering to established regulatory standards. Coordinating quality and editorial reviews. Acting as peer reviewers for the internal team. Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency. Interacting and building good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs. Performing online clinical literature searches and complying with copyright requirements. Identifying and proposing solutions to resolve issues, providing technical support, training, and consultation to department and other company staff. Mentoring and leading less experienced medical writers on complex projects. Developing deep expertise on key topics in the industry and regulatory requirements. Working within budget specifications for assigned projects. Show more Show less

Description. Medical Writer II (CTT). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Mentors less experienced medical writers on projects, as necessary.. Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision.. Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures.. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.. Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format.. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.. Performs on-line clinical literature searches, as applicable.. Working knowledge of drug development process and regulatory guidelines.. Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing.. Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.. Completes required administrated tasks within the specified timeframes.. Performs other work-related duties as assigned.. Minimal travel may be required (less than 25%).. Qualifications. Minimum 3 years of experience in Clinical Trial Disclosure (CTD), Clinical Trial Transparency (CTT) and Regulatory Medical Writing.. Preferred experience with results posting for regulatory bodies such as US FDA, ClinicalTrials.gov (ct.gov), EudraCT and national registries.. Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.. Strong proficiency in Word, Excel, PowerPoint, email, and Internet.. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

Job Description:. Weekly Hours:. 40. Time Type:. Regular. Location:. IND:AP:Hyderabad / Argus Bldg 4f & 5f, Sattva, Knowledge CityAdm: Argus Building, Sattva, Knowledge City. It is the policy of AT&T to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, AT&T will provide reasonable accommodations for qualified individuals with disabilities. AT&T is a fair chance employer and does not initiate a background check until an offer is made.. Show more Show less

Description. Sr Regulatory Consultant (Portfolio Management, EU mkt). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Minimum 5 years of experience in the European regulatory market.. Must have experience of end-to-end portfolio management within the EU region; global exposure is highly desirable.. Strong expertise in regulatory planning and strategy, including dossier preparation for filings, project management, labeling, and development of regulatory processes and procedures.. Hands-on experience with CTD modules 1 through 4, with a deep understanding of regulatory requirements and documentation standards.. Responsible for day-to-day contribution to project teams and projects.. Acts as a representative of the GRAS regulatory department with other departments.. Contributes technical expertise to proposals and assists with Business Development initiatives.. Understands project budgets, scope of projects, allocated hours, and tracks compliance.. Interacts with internal and external personnel, clients, and technical experts on projects.. Conducts regulatory research on projects as needed.. Provides operational advice to clients.. Prepares consulting reports under guidance.. Arranges, leads, and reports on client meetings.. Contributes to regulatory agency meetings.. Writes IND and product registration dossiers, clinical reports, and other regulatory documents for submissions.. Prepares full regulatory submissions for INDs, product registrations, and post approval maintenance activities, and participates on project teams.. Acts as a resource for technical knowledge.. Participates in quality improvement efforts to increase overall operational efficiency.. Contributes to the building of the regulatory systems and infrastructure needed for GRAS.. Develops reputation for the Company as industry leader in Regulatory by attending and speaking at industry eventssuch as seminars and association meetings, authoring articles for trade journals, and participating in industry association through memberships and on committees.. Provides internal training in appropriate areas of expertise to other Departments.. May act as a Line Manager to a small team, dependent on the location.. Qualifications. BS degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field. PhD preferred.. Moderate regulatory, pharmaceutical/medical device related experience.. Demonstrated experience in contributing to the preparation of regulatory submissions including for example IND, PMA, NDA, MAA, and CTD, including electronic submissions. Experience in niche submissions such as ODD, PIP/PMP an advantage.. Excellent interpersonal / communication skills including excellent written and verbal communication skills.. Excellent customer service skills, with the ability to work both as a team member and independently.. Good quality management skills.. Problem-solving and decision-making skills.. Advanced skills in Microsoft Office Applications.. Ability to interact with staff from multiple departments and offices to establish project standards.. Good initiative, adaptability, and pro-activity.. Strong analytical skills, good attention to detail.. Ability to work concurrently on projects, each with specific instructions that may differ from project to project.. Fluent in speaking, writing, and reading English.. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

About The Job. Our Team:. Sanofi Global Hub (SGH) is an internal Sanofi resource organization based in India and is setup to centralize processes and activities to support Specialty Care, Vaccines, General Medicines, CHC, CMO, and R&D, Data & Digital functions. SGH strives to be a strategic and functional partner for tactical deliveries to Medical, HEVA, and Commercial organizations in Sanofi, Globally.. Main Responsibilities. The overall purpose and main responsibilities are listed below:. Create HEVA communications deliverables (including manuscripts, posters, abstracts, slide decks) aligned with HEVA strategy and global HEVA communication plan across relevant business units and product teams. Manage core HEVA communication processes, templates, and products across the portfolio in accordance with the scientific and value messages aligned with Core Value Dossier, the US AMCP Dossier, and HEVA contributions as appropriate to other submissions. Ensure Core Value Decks for key products are established and maintained, making available a regularly updated synthesis of critical HEVA evidence on the value of products. Maintain accountability for adherence to the publication standard operating procedure (SOP) and other compliance expectations relevant to HEVA communication processes. Seek opportunities to innovate HEVA value communications to increase the relevance and impact of HEVA evidence and inform optimal access and reimbursement decisions. Develop and maintain therapeutic area expertise. Coach junior HEVA writers and develop and review content created by them. Manage end to end process through iEnvision (previously, Datavision/Matrix). Collaborate effectively with stakeholders: HEVA, RWE, and Scientific communication global and/or local teams.. People: (1) Maintain effective relationships with the end stakeholders within the allocated GBU and product – with an end objective to develop education and communication content as per requirement for HEVA communications; (2) Interact effectively with healthcare professionals on publication content; and (3) Constantly assist other writers (junior) in developing knowledge and sharing learning. Performance: (1) Create HEVA communications deliverables (including manuscripts, posters, abstracts, and slide decks) aligned with HEVA strategy and global HEVA communication plan across relevant business units and product teams as per agreed timelines and quality; and (2) Provide strategic support with individuals and institutions, which may serve as resources for publications purpose, etc. Process: (1) Develop complex publications material; (2) Act as an expert in the field of medical communication for the assigned therapeutic area; (3) Assist the assigned scientific communication team in conducting comprehensive publication-needs analysis; (4) Manage core HEVA communication processes, templates, and products across the portfolio in accordance with the scientific and value messages aligned with Core Value Dossier, the US AMCP Dossier, and HEVA contributions as appropriate to other submissions; (5) Ensure Core Value Decks for key products are established and maintained, making available a regularly updated synthesis of critical HEVA evidence on the value of products; (6) Maintain accountability for adherence to the publication SOP and other compliance expectations relevant to HEVA communication processes; (7) Maintain accountability for adherence to the publication SOP and other compliance expectations relevant to HEVA communication processes; (8) Implement relevant element of publication plan and associated activities for the year identified for the region; (9) Work with selected vendors within the region to deliver the required deliverables as per defined process; and (10) Design an overall plan of action based on end-user feedback and improve course content and delivery. Stakeholder: (1) Work closely with HEVA global and local teams, RWE global and local teams and scientific communication teams in regions/areas to identify publications needs and assist in developing assigned deliverables; and (2) Liaise with HEVA global and local teams to prepare relevant and customized deliverables. About You. Experience: >4 years of experience in content creation for the pharmaceutical/healthcare industry, or academia. Soft skills: Stakeholder management; communication skills; and ability to work independently and within a team environment. Technical skills: Relevant training/experience in health economics, public health, epidemiology, or other relevant health-related scientific discipline (including but not limited to therapeutic area/domain knowledge exposure; knowledge of Good Publication Practice; publication submission; and/or project management). Education: Advanced degree in life sciences/pharmacy/similar discipline or medical degree. Languages: Excellent knowledge of English language (spoken and written). Pursue progress, discover extraordinary. Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!. null. Show more Show less

Description. Regulatory Associate (CMCPre and post approval ). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Assists with preparation of product development documents including gap analyses and clinical development plans.. Minimum 2 years of relevant experience. Assists with preparation of regulatory submission documents including components of investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities, according to current government regulations and guidelines.. Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests.. Performs quality checks on related documents.. Assists with submissions of other regulatory documents and other regulatory research as needed.. Assists clients, customers, or others with general information. Gathers, compiles, analyzes, and reports information.. Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence.. Qualifications. MS in science/healthcare field, or equivalent combination of education and experience.. Minimum 2 years of relevant experience. Excellent interpersonal / communication skills.. Advanced skills in Microsoft Office Applications.. Good time and project management skills, preferred.. Strong analytical skills and attention to detail.. Ability to work both as a team member and independently and to understand and carry out detailed instructions.. Ability to interact with staff from multiple departments.. Ability to work concurrently on projects, each with specific instructions that may differ from project to project preferred.. Fluent in speaking, writing, and reading English.. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

Medico- Marketing conducting CMEs and other meetings, participation in the congresses etc. Clinical trial support knowledge of clinical research which includes site evaluation, initiation for clinical studies planned in the year, registries, approvals, data analytics. Self-Development- should create engagement programs, post marketing surveillance, data publication and medical write up. The Clinical Product Specialist is responsible for collaborating with cross-functional stake holders to define, develop and execute marketing strategies and tactics for specified product segment to help achieve revenue and profit expectations. Would work in collaboration with the Sales & Marketing team. Communicates and works with counterparts in technical management, R&D, medical directorship, marketing and sales to define product attributes, go-to-market strategy, product positioning, key benefits, and target customers. Additional Skills.

Jobsguru looking for a Medical Advisor for our pharma client in Mumbai. Contribute to the development of the medical components of the Brand Strategy and develop a Medical Plan. Mail CV search@jobsguru.in 9302574002 Shreya Jobsguru Consultant P Ltd Required Candidate profile Should be M. Pharma Excellent presentation and teaching skills Highly effective communicator both oral and written Can develop training material Excellent presentation and teaching skills

Description Sr Medical Writer (Redaction) Syneos Healthis a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities, Our Clinical Development model brings the customer and the patient to the center of everything that we do We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for, Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives, Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program, We are committed to our Total Self culture where you can authentically be yourself Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people, We are continuously building the company we all want to work for and our customers want to work with WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives were able to create a place where everyone feels like they belong, Job Responsibilities Authoring andQuality Assurance of Project Activities Executes project specific activities with high quality and in defined timelines according to standard processes and operating procedures Marking /QC/Review and/or editing of pertinent documents such as: o Clinical study documents or any other documents for regulatory submission i-e , clinical study reports, patient narratives, clinical summaries etc for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH) o Protocol and results summaries to support clinical trial disclosure commitments Systematically perform quality control checks of documents prepared by colleagues against pre-specified checklist generated in the project or SOP Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs Ensure to abide with Client process 2 Additional Activities Completion of Internal and Client specific training Assist in mentoring and training of team members depending upon project requirement(s) Qualifications We are looking for 4-8 yearsexperience medical writer who will be involved in redactions/anonymization of clinical documents as part of preparation for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH) Candidate should be well versed with all the related regulations, perform quality review, client communication and management, Experience in preparing disclosure documents (such as Protocol Registration Form and Result Registration Form) for clinicaltrials gov and for various other clinical registries will be added advantage Resource should understand & comprehend protocol and clinical study report from disclosure perspective Good understanding of Clinical Trial Disclosure fundamentals is expected Qualification Requirement Educational qualifications: A minimum of a scientific graduate degree in life sciences, Good knowledge of regulatory requirements or guidance pertinent to the service line, Good understanding of clinical development processes including principles of clinical study operations and ICH-GCP guidelines Clear written and verbal communication skills Good knowledge of basic computer applications, e-g MS Word/ PowerPoint/ Excel, will be required, Person should understand & comprehend protocol and clinical study report from disclosure perspective, Good understanding of clinical trial disclosure fundamental Core competencies for this role include ability to demonstrate: o Analytical capabilities with scientific and clinical data o Professional working environment o Ownership of the work allocated o Commitment to highest quality outputs, including high attention to detail o Enthusiasm and pro-activity o Effective team working Ability to build rapport/ relationships with project-specific client colleague Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients, No matter what your role is, youll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment Learn more about Syneos Health, http://syneoshealth, Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above Further, nothing contained herein should be construed to create an employment contract Occasionally, required skills/experiences for jobs are expressed in brief terms Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job,

Bhosale Micropath Laboratory is looking for Dip. Physician Asstt. to join our dynamic team and embark on a rewarding career journey Collaborate with physicians and other healthcare professionals to provide comprehensive patient care Conduct patient assessments, including medical history reviews, physical examinations, and diagnostic tests Diagnose and treat acute and chronic medical conditions under the supervision of a licensed physician Develop and implement patient care plans, including prescribing medications, ordering and interpreting laboratory tests, and providing patient education Perform procedures and assist in surgeries, as appropriate to the specialty and setting Monitor and evaluate patient progress, adjusting treatment plans as necessary Document patient encounters, including medical histories, treatment plans, and progress notes, in electronic medical records (EMRs) Communicate with patients and their families regarding diagnoses, treatment options, and follow-up care Collaborate with interdisciplinary teams to coordinate patient care and ensure continuity of care Stay updated with current medical literature and best practices in healthcare Adhere to legal and ethical standards, including maintaining patient confidentiality and following professional codes of conduct Participate in quality improvement initiatives and contribute to the development of clinical protocols and guidelines Assist in training and mentoring other healthcare professionals, such as medical students or nurses, as appropriate

The Global Scientific Communications Content Hub is a growing, high performing, collaborative team responsible for developing medical communications, medical education and medical information content in close collaboration with a range of teams across Healthcare. The team is based in Global Healthcare's multi-disciplinary R&D (Research & Development) Hub in Bengaluru and working together across our global medical units (Oncology, N&I, Fertility, CM&E and Global Health). We are seeking experienced, passionate scientific writing professionals who would like to develop their career and contribute to the continued growth of our operations. Your Role: Working both independently and alongside other team members to develop medical content for a range of project types, audiences and writing styles including, but not limited to, medical communication content (including publications and congress materials) and medical education content Actively contribute to improvement initiatives across the Global Scientific Communications Content Hub Lead development of medium to high complexity content (and review the same produced by others) Review (QA) the output of less senior writers (including scientific accuracy, tone and alignment with agreed strategic messaging) Lead concept and content development meetings with authors and other stakeholders. Lead representative/SMEs for the assets/functional areas they are assigned on; develop programs to increase the depth of understanding of more junior writers Maintain good relationship with stakeholders (e.g. within MUs) Ensures personal efficiency and productivity targets are met Manages and prioritizes workload to meet internal deadlines Ensures status reporting of projects is clear You will have: 9+ years professional experience in medical communications/medical affairs/clinical research in an international Pharma/Biotech/agency setting A proven track record of successful scientific writing and leading projects; are comfortable with developing a range of content types, sometimes concurrently, and able to prioritize tasks to meet timelines/deadlines An advanced university degree in science, medicine or another related subject Therapeutic expertise/experience in one or more of Organization's key therapy areas (Oncology, Neurology and Immunology, Fertility, Cardio-metabolic and Endocrinology) Demonstrable stakeholder management expertise Strong awareness of the pharmaceutical business and trends in the industry Experience in managing projects cross-functionally and in an international setting Strong analytical skills and ability to understand complex processes, project management and project leadership skills Excellent verbal and written communication skills (English language)

Graduate or post graduate in Pharmacy, Nursing or life sciences. Certification in Medical writing or Diploma in clinical research would be desirable. Preferred experience for the Author role: Preferably 1 to 2 years of experience in medical writing domain. Life science graduate with 1 to 3 years of experience Responsibilities of Author: 1. As per process requirement and assigned primary responsibility, support CSR patient narratives (draft and QC) 2. Ensure that the narratives are in accordance with the client SOPs, guidelines and agreed timelines and comply with client quality standards 3. Perform Quality check of the narratives according to the project specific checklist and against the source documents such as patient listing, concomitant medication listing, CIOMS form etc. and log defect in the defect tracker after analyzing the defect category 4. Attention to detail, work under stringent timelines on a need basis, and switch between different projects, as required 5. Be responsible for the quality and timelines of the deliverables as designated/allocated in the project. 6. Proactive communication with lead narrative writers to meet the narrative writing quality and timelines 7. Complete assigned training within stipulated timelines 8. Provide timely data (study tracker, quality metrics, billing numbers/effort hours) for preparing relevant (e.g. quality, TAT, effort hours, etc.) and project status updates, as defined by the client requirements Key Skills: a) Grad or PG in Nursing, Pharmacy or Life Sciences b) 1 to 2 years of experience in medical writing

To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills

Role & responsibilities: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.). To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation.

Primary Responsibilities: Review and analyze patient medical records for accurate code assignment Ensure adherence to coding guidelines and regulatory requirements Learn to use medical coding software Apply understanding of anatomy and physiology to interpret clinical documentation and identify applicable medical codes Stay updated on industry changes and attend relevant training sessions Ensure confidentiality and security of all patient information Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do so #NTRQ Required Qualifications: Bachelors degree or masters degree, from a medical science backdrop or anything relevant Life Science or Bioscience, Pharmacy or Pharmaceutical Sciences, Nursing or Medicine Allied Health Good knowledge in medical terminology basics Good knowledge in Anatomy physiology basics Well-versed with ICD-10 guidelines and their implementation Proficient in reviewing medical records and determining the accuracy and completeness of the document Preferred Qualifications: AAPC/AHIMA Certification Risk Adjustment coding experience At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone of every race, gender, sexuality, age, location and income deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes an enterprise priority reflected in our mission.

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by diversity and inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health equity on a global scale. Join us to start Caring. Connecting. Growing together Primary Responsibilities: Review and analyze patient medical records for accurate code assignment Ensure adherence to coding guidelines and regulatory requirements Learn to use medical coding software Apply understanding of anatomy and physiology to interpret clinical documentation and identify applicable medical codes Stay updated on industry changes and attend relevant training sessions Ensure confidentiality and security of all patient information Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do #NTRQ Required Qualifications: Bachelors degree or masters degree, from a medical science backdrop or anything relevant Life Science or Bioscience, Pharmacy or Pharmaceutical Sciences, Nursing or Medicine Allied Health Good knowledge in medical terminology basics Good knowledge in Anatomy physiology basics Well-versed with ICD-10 guidelines and their implementation Proficient in reviewing medical records and determining the accuracy and completeness of the document Preferred Qualifications: AAPC/AHIMA Certification Risk Adjustment coding experience At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone of every race, gender, sexuality, age, location and income deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes an enterprise priority reflected in our mission.

Responsibilities: Review client case information and determine required medical records and facilities involved. • Initiate medical record requests via fax, email, portals, or telephonic communication in compliance with HIPAA and client-specific protocols. • Regularly follow up with hospitals, clinics, and third-party record retrieval services (e.g., MRO, CIOX) to track the status of requests. • Escalate delays, incomplete records, or denials to appropriate stakeholders and take corrective action. • Update internal tracking systems, logs, and client databases (e.g., Clio, Filevine, Needles) with current status and notes. • Communicate professionally and clearly with providers, clients, and internal teams via email and calls. • Perform quality checks to ensure completeness and accuracy of received records before submission to legal teams. • Maintain turnaround time (TAT) and service level agreements (SLAs) for all assigned cases. • Review and analyze scanned medical records and bills and summarize them as per the guidelines. • Create concise and accurate summaries of patient medical histories, procedures, diagnoses, and treatment plans for internal use and billing purposes. • Maintain organized records of summarized information, ensuring compliance with legal and regulatory standards. Preferred Tools & Platforms Experience (Mandatory): • Clio, Filevine, Litify, or Needles • Record retrieval platforms (CIOX, MRO, ChartSwap, Sharecare) • SharePoint, Dropbox, Google Drive • Nitro, Microsoft word, excel, outlook. Key Skills: Strong understanding of medical terminology. Excellent written communication skills with attention to detail. Proficiency in Microsoft Office Suite and electronic health record (EHR) systems. Preferred Candidate Profile Bachelors degree in life sciences is mandatory (BPT, MPT, BAMS, BHMS, BUMS, and BDS) Should have proficiency in Typing (30 WPM with 97% of accuracy) Should be flexible with 24*7 shift. Freshers can apply. Package: ~ 3.16 LPA for Freshers ~ up to 4.2 LPA for experienced Preferred Candidate Profile: Graduation is mandatory Should be flexible with 24*7 shift. Learning Opportunities Freshers can also apply, must have knowledge about medical terminologies Great work culture Positive Work Environment Immediate Joiners only *** Walk In Details Venue - Provana, A-5 Sector 6 Noida. Time - 10 AM IST Date - 21th June 2025 (SATURDAY) HR Reference : YAMINI MOURYA || PINKI JHA

Job Role: Review, edit, and format research papers for publication. Ensure grammatical accuracy, clarity, and proper citation styles. Coordinate with authors and researchers for revisions. Maintain publication standards and adhere to journal guidelines. Assist in proofreading and finalizing manuscripts. Work with MS Word and other editing tools to enhance document presentation. Skills Required: Strong English writing and editing skills. Attention to detail and accuracy in formatting. Proficiency in MS Office (Word, Excel).

Oversee the maintenance of patient medical records. Ensure accuracy and confidentiality of medical records. Coordinate with other departments for record retrieval. Train and supervise medical record staff. Implement and enforce record-keeping policies.

Work closely with Senior director (EBM strategic planning and operations), business partners, therapy areas lead, eBuy manager, external vendors, and finance colleagues to support coordination and management of various activities Work with TA Leads to conduct monthly/bimonthly/quarterly budget reviews and ensure full oversight; identify US budget needs; coordinate with cross-functional teams to operationalise strategic plan, brand plan and prioritization; identify areas of support needed; develop and maintain TA project tracker; to track and update on monthly worksheet issues flagged Work with business partners to perform monthly review of budget plans and actuals; complete North America (NA) intake form and update budget tracker with SOW details, shift funds on tracker to align with finance; provide updates on pending contracts, identify any challenges and follow-up on invoicing issues; follow-up on cross charges by end of November to make sure they hit the books; coordinate and assist to set-up Ad-board meetings Coordinate with ITA team for organising external meetings and activities such as GRFs, FMVs, tiering, honoraria tables and cost-sheet etcCoordinate with finance colleagues to communicate any discrepancies between finance trackers and BPs budget tracker, cost centre mistakes and for any amendments as needed Work with vendors on contract support to onboard vendors; ensure final approved SOW is processed via NA Intake form, follow-up on contract and PO, forward PO to vendor; support with contract renewals or amendments; follow-up on PV training; monitor invoices to be processed; schedule meetings and prepare meeting minutes Responsible for project management support to the scientific writer and HEVA ensuring the end-to-end effective project delivery of the designated publication/medical education and HEVA deliverable across all phases Initiate submission (as required), amend submission based on comments (as required). Support the writer with the development of a scope of work; build plan and schedule for agreement with the internal stakeholders Arrange key internal and external stakeholder meetings. Track the delivery of activities (including managing issues and risks) and support follow up Support tracking GD requests and ensuring they are executed on time Support in and maintaining and tracking editorial and QC request for publications and other deliverables. Also make sure stipulated timelines are met Support required submission, compliance, and approval activities, and ensure compliance with publication processes and use of publication management tools Support the management of the assigned publication or medical education in line with the agreed budget. Support and manage as required external spend tracking (eg, approvals, purchase orders, and goods received) Support HEVA team in fetching articles from Rightfind or relevant scientific databases Support HEVA team members in sourcing full texts of paid articles from other sources and managing their procurement processes as per the standard guidelines Support HEVA team in downloading and categorisation of booklets and information, respectively, from various congress websites as per the eligibility criteria Support adherence to associated compliance related activities and approvals (with internal stakeholder taking accountability for compliance) Update as required with approval/compliance tools (eg, PromoMats, NAYA) Manage end to end process through Datavision, Matrix, RightFind, Ebuy, PrismAccess, etc Collaborate effectively with stakeholders: Scientific communication global and/or local teams/HEVA teams; and medical content enhancement teams People: (1) Maintain effective relationship with the end stakeholders (medical scientific community) within the allocated GBU and product - with an end objective to develop education and communication content as per requirement; (2) Actively lead and develop SGH operations associates; (3) Ensure new technologies are leveraged; (4) Support vendor engagements, advisory boards scientific events activities & external expert contracts; (5) Initiate the contracting process and related documents within defined timelines; and (6) Collaborate with global stakeholders for project planning and setting up the timelines and maintaining budget Performance: 1) Coordinate all contracting and budgeting tasks diligently (2) Work with HEVA TA Leads to conduct monthly/bimonthly/quarterly budget reviews and ensure full oversight (3) Work with business partners to perform monthly review of budget plans and actuals (4) Coordinate with ITA team for organising external meetings and activities (5) Coordinate with finance colleagues to communicate all discrepancies (6) Ensure publication/medical education materials (slide decks, abstracts, posters, manuscripts, newsletters, pub alert, etc) are delivered, stored as per agreed timelines and quality; (7) Develop tools, technology, and process to constantly improve quality and productivity; (8) Support SGH HEVA team in timely review and audit of all DataVision entries; (9) Support SGH HEVA team in all operations related projects; (10) Perform quality check for HEVA documents; (11) Maintain HEVA Smartsheet/projects trackers as needed and make sure all entries are up to date for all projects and; (12) Support global HEVA team to maintain trackers and facilitate retrieval of required information for business reviews as needed (13)Work with vendors on contract support to onboard vendors Process: (1) Support delivery of projects in terms of resourcing, coordination, quality, timeliness, efficiency, and high technical standards for deliveries made by the medical writing group, including scientific documents and clinical/medical reports; (2) Contribute to overall quality enhancement by ensuring high scientific standards for the output produced by the medical writing group; and (3) Secure adherence to compliance procedures and internal/operational risk controls in accordance with any and all applicable regulatory standards Stakeholder: Work closely with scientific communication/medical content enhancement/HEVA teams/finance teams and external vendors to ensure the end-to-end effective project delivery of the designated publication/medical education deliverables About you Experience : Medical communication/pharma experience desirable. Project management experience required. 3-5 years post qualification experience. Project management/medical communication/pharma experience desirable. Soft skills : Stakeholder management; writing/communication skills; external engagement and ability to work independently and within a team environment Technical skills : Contracting, budgeting, vendor management, including but not limited publication ops support; and/or project management Education : Advanced degree in life sciences / commerce / engineering / pharmacy / similar discipline Languages : Excellent knowledge of English language (spoken and written)

Summary Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. About the Role Key Responsibilities Study Level-Responsible for all statistical tasks on the assigned trials, and perform these tasks for mid- to high- complexity trial independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial de-signs in alignment with the Lead Statistician. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required. Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team. Oversee all Biostatistics resources and deliverables for assigned trials. En-sure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project level- May be a core member of an early project team for a low-complexity program and represents Biostatistics and Pharmacometrics as part of development plan with oversight. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned indications/program with oversight. Collaborate cross-functionally (e. g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables. Propose and implement innovative designs and methods to optimize dose finding and drug development. Contribute to planning, prioritization and tracking of program level biostatistics activities and effective partnership with vendors. Significantly contributes to project team preparation for HA Advisory Committees and meetings. Franchise or Global Line Function level: Significantly contribute to initiatives at global line function level Enterprise level- Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and out-side the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewed journals, presentations and chairing sessions at professional meetings. External level- Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Role Requirements : MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 3+ years relevant work experience Fluent English (oral and written) Good communication and presentation skills Influences decisions that directly impact the trial/project and team ability to deliver objectives. Experience in all tasks of a statistician at the trial/experiment level and demonstrated independence in the role. Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e. g. SAS, R). Good knowledge of drug development and Health Authority guidelines. Demonstrated effectiveness working on a multidisciplinary team to achieve team objectives. Good understanding of Franchise/Therapeutic Area and or regulatory activities. Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions. Good business ethics Commitment to Diversity and Inclusion: Accessibility and accommodation Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Job description : Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports Demonstrate the ability to independently manage the production of safety deliverables, including those involving complex data analyses or important safety issues Act as a technical lead of the medical writing teams across projects and provide guidance and expertise for developing high-quality scientific content as required for various safety deliverables Establish good client communication and coordination within writing teams to manage stakeholder expectations and resolve any issues surrounding project/report deliverables Contribute to scientific publications and represent the company at scientific meetings and conferences Work with the project management team to implement quality and process improvement initiatives Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time. Summary of Responsibilities: Write and review various safety reports for global regulatory submissions for clients, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Report, Clinical Overviews, Medical Device reports, and other documents as assigned. Lead the end-to-end process of report production and ensure the required quality standards and key timelines are met. Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work/contributions. Act as the primary point of contact for the client for all report management activities. Engage in client communication to manage stakeholder expectations, present anticipated challenges, propose remediation, and escalate unresolved issues impacting deliverables at an individual report or project level. Author/review RMPs, ad hoc reports, Benefit-Risk Evaluation reports, supporting documents for label updates, reports of effectiveness of risk minimization measures or enhanced pharmacovigilance activities. Lead/participate in various steps of the signal management process. Provide inputs for developing signal strategies and retrieval of data from safety databases, scientific literature, and other sources, as required. Author/review signal evaluation/management reports (ad hoc and periodic) and safety issue analysis reports. Participate in safety/benefit-risk review meetings with clients, discuss results and conclusions from signal/safety analysis, and in collaboration with the safety physician, propose label updates and other risk mitigation measures, as needed. Draft responses (or parts thereof) to health authority questions or feedback and collaborate with cross functional stakeholders in the management and tracking of such feedback. Develop abstracts, posters, manuscripts, and other documents for scientific publication or presentation at conferences or pharmacovigilance forums. Prepare medical information responses for HCPs. Act as a writing coach, provide regular quality feedback, conduct training, and share best practices with associates for promoting the use of clear and concise writing and adherence to style guides, as applicable. Support project management activities such as maintenance of project schedules and tracking of metrics and compliance. Contribute to business development activities, including estimation of resource requirement and responding to RFPs. Create and update labels, e.g. Core Data Sheets, USPI, centralized SPC s, Med Guides. Conduct literature reviews, formulate and execute search strategies, including those for complex topics or research questions. Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables. Ensure compliance of operations with governing regulatory requirements. Create, maintain, and assume accountability for a culture of high customer service. Perform any additional activities per project requirement or at the manager s discretion upon completion of relevant training. And all other duties as needed or assigned. Qualifications (Minimum Required): Minimum of first degree in life sciences (or equivalent). Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): At least 5-7 years of experience in the pharmaceutical industry, with at least 4 years of it in medical writing. Excellent command of written and spoken English. Good written and verbal communication skills. Knowledge of MS Office. Good organizational and time management ability. Excellent interpersonal and leadership skills. Scientific or clinical research or medical writing experience desirable. Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH GCP guidelines.

Primary responsibilities 1.Medical monitoring of the in-house clinical trials and overseeing of CRO medical monitoring of outsourced projects 2.Development and review clinical documents including protocol, investigator's brochure, case record form, product rationale, prescribing information, drug interactions etc 3.Organization of Subject Expert Committee meeting materials and attending SEC meetings for clinical trials and marketing approvals Secondary responsibilities 1.Medical Review of ICSRs, Aggregate reports, Signal reports and Risk Management plans 2.Review of clinical and non-clinical overviews and summaries of CTD 3.Review of medical rationale for CT waiver applications 4.New products evaluation for development 5.Develop, review and approve marketing requests of product evaluations, comparative safety and efficacy training material 6.Mentoring/ training team members to gain required skills to enable on-time deliverables.

Role Regional Managing Partner - Deputy Vice President, Kotak Agency - Field Sales (L7) Experience 6-12yrs. Job Role Recruitment Parameters -Increasing Distribution through Coding of new Partners & increasing LA base -Pragati Promotion -SAP / CAP Creation -Partner Promotion -Handhold & Coach Distribution for Recruitment -Minimum Distribution Criteria of 8:80 Business Parameters -Meet the budgeted business numbers -Maintain minimum Persistency of 85% -Coach & Train Agency to work Independently & Digitally -Meet the CLA numbers -Initiatives to improve Partner Income -Periodic meeting of Partners & Las -Support Agency with all relevant report & MIS Primary Responsibilities External Relations Internal Relations Educational qualifications preferred Category Bachelor's Degree