278 Medical Writing Jobs

Note: This role would involve Rotational Shifts (Morning and Nights) Basic roles: Patient care Maintain compliance Clinically sound Assist the surgeon/Consultant Roles and Responsibilities Basic roles: Patient care Maintain compliance Clinically sound Assist the surgeons

PMS College of Dental Sciences & Research is looking for Asst Proffesor - Pharmacology to join our dynamic team and embark on a rewarding career journey Develop and deliver high-quality lectures and instructional materials. Conduct research and publish findings in academic journals. Advise and mentor students on academic and career matters. Participate in academic committees and contribute to curriculum development. Stay current with developments in the field and incorporate them into teaching.

Lilavati Medical Center is looking for Clinical Associate - Radiology to join our dynamic team and embark on a rewarding career journey Perform and interpret diagnostic imaging procedures, including X-rays, MRI, CT scans, and ultrasounds. Provide expert consultation to other physicians regarding radiologic findings. Ensure high-quality imaging and patient safety. Stay updated with advancements in radiology technology and techniques. Participate in multidisciplinary team meetings to discuss patient care plans. Conduct research and contribute to radiology publications. MD/DNB (Radiology) with post graduate experience from a reputed Hospital.

Medical Writer II (CSR Narrative exp Only) 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 - Min 3 years of medical writing experience and minimum 3yrs of relevant experience in Narrative writing - Good Experience of independent authoring and reviewing CSR Narratives only. 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.

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.

Medical Writer II (Clinical Trial Transparency) 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 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.

Sr Medical Editor 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 Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. Represents the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed. Monitors timelines and budgets for assigned projects and updates the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk. Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on data integrity review, compilation, publishing, and editorial standards. Provides training to members of the global Medical Writing team in aspects relative to their roles. Project lead for deliverables of assigned complex and/or large medical writing projects, including but not limited to scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring that all information is distributed to the editorial team and implemented within the deliverable. Serves as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on progress of document editorial process. Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following American Medical Association (AMA) or various custom style guidelines as well as established medical writing internal checklists and best practices. Performs data integrity review of assigned documents to ensure accuracy. Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work. Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget. May compile and publish medical writing deliverables. - Edit documents such as Standard Operating Procedures (SOPs) and business practice documents as part of the Asset Writing team. - Good command over English language and core editing experience is required Qualifications Bachelor s degree (preferred) in the life sciences, clinical sciences, or English/journalism; or copyediting, data integrity review, and/or relevant publishing experience. Significant relevant publishing experience using Adobe Acrobat or other appropriate markup language preferred; ISIToolbox experience preferred. Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Excellent attention to detail, including strong copyediting, data integrity review, accuracy, problem solving, organizational, interpersonal, presentation, project management, and team-oriented skills. Excellent grammatical and communication skills, both written and oral. Extensive familiarity with the AMA style guide strongly preferred. Ability to work with minimal supervision on multiple assignments with set deadlines. Ability to work independently as well as part of a team and keep others informed of the progress and statusof projects. Adaptable to changes in work duties, responsibilities, and requirements. Knowledge of FDA and EU requirements, ICH regulations and ISO standards as applicable to regulatory documents preferred. 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.

We are seeking life science graduates interested in building a long-term career in the Clinical Research domain. This opportunity is part of our industry-integrated Clinical Research Training Program designed to prepare candidates for roles such as CRA, CRC, and Drug Safety Associate . Role Responsibilities (Post-Training Readiness) Understand and support clinical trial processes, site coordination, and documentation Learn Good Clinical Practices (GCP), ICH guidelines, and regulatory frameworks Monitor data collection and compliance Collaborate with CROs, hospitals, and research organizations (Post-placement) Eligibility Criteria Education: B.Sc, B.Pharm, M.Sc, BDS, BPT, BHMS, BAMS, Nursing, MBBS Background: Life Sciences or Healthcare domain Experience: 02 years Location: Open to all Indian cities (program delivered online & offline) Must have interest in Clinical Trials, Research, Pharmacovigilance, or Regulatory Affairs

Possess excellent medical knowledge, including a strong grasp of medical terminologies and complex disease conditions. Display a keen analytical mindset, enabling you to process and extract key information from medical records. Call 9318431991 Required Candidate profile Graduate or Post Graduate in Bachelor in Physiotherapy BPT, BDS , BHMS, or B. Pharma 2-4 years in medical records underwriter Rotational Shift, WFO Noida Location info.aspiringmantra@gmail.com

Job Description: The Clinical Pharmacist at Manipal Hospitals will be responsible for optimizing patient medication therapy to ensure safe and effective pharmaceutical care. The role includes conducting medication reviews, collaborating with healthcare professionals to develop therapeutic plans, and ensuring adherence to clinical guidelines and policies. The Clinical Pharmacist will also provide pharmacotherapy consultations, educate patients and healthcare staff regarding medication use, and participate in clinical rounds to monitor patient progress. Roles and Responsibilities Key Responsibilities: - Review and interpret medication orders to ensure appropriateness, safety, and efficacy. - Collaborate with physicians, nurses, and other healthcare professionals to develop and manage pharmaceutical care plans. - Conduct medication reconciliation and provide education to patients regarding their medications. - Monitor and evaluate patients for drug therapy outcomes, side effects, and drug interactions. - Participate in clinical rounds and provide input on medication-related issues. - Develop and implement policies and procedures relating to medication management. - Provide training and guidance to pharmacy staff and other healthcare professionals. - Stay updated with the latest research and developments in pharmacotherapy.

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.