therapeutic-area-jobs-in-idukki, Idukki

3 Therapeutic Area Jobs nearby Idukki

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posted 3 weeks ago

Senior Medical Writer

Silmed Scientific
experience2 to 8 Yrs
location
Kochi, Kerala
skills
  • Authoring
  • Clinical Development
  • Communication Skills
  • Writing Skills
  • Regulatory Medical Writing
  • Reviewing
  • Regulatory Submission Documents
  • CTD Modules
  • Safety Efficacy Summaries
  • Aggregate Safety Reports
  • Product Monographs
  • SmPCs
  • Patient Information Leaflets
  • Regulatory Strategy Reports
  • Nonclinical Development
  • Literature Search
  • Therapeutic Areas Knowledge
  • Vancouver Style Referencing
  • Medical Literature Databases
Job Description
You will be responsible for the following key tasks: - Authoring and reviewing Regulatory submission documents for obtaining marketing authorization of pharmaceuticals in Europe and United States, including Common Technical Document (CTD) modules such as nonclinical and clinical overviews & summaries (Module 2.4, 2.5, 2.6, and 2.7), expert reports, safety & efficacy summaries, Aggregate safety reports like Periodic Safety Update Reports (PSURs), bridging reports, Periodic Adverse Drug Experience Reports (PADER), policy papers, RMPs, etc. - Crafting product monographs, SmPCs, and Patient information leaflets - Developing Regulatory strategy reports - Providing advice on clinical/nonclinical Development questions and preparing biowaiver reports - Conducting Literature Search Qualifications required for this role are as follows: - MPharm or Ph.D. in Pharmacology - MBBS or MD in Pharmacology - 2-8 years of experience in Medical writing - Excellent communication and writing skills - Prior experience in Regulatory Medical writing for EU Submissions with reputed pharma companies - Proven track record in writing CTD modules 2.4 and 2.5 for generic and bibliographic applications is a must - Ability to present research data to the target audience in a reader-friendly manner - In-depth knowledge of various therapeutic areas - Knowledge of relevant guidelines related to structure and contents of specific documents with a good understanding of Vancouver style of referencing - Familiarity with searching medical literature databases such as PubMed, EMBASE, etc.,
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posted 2 months ago
experience0 to 4 Yrs
location
Kerala
skills
  • Cell Biology
  • Genomics
  • Biochemistry
  • Market Analysis
  • Team Management
  • Presentation Skills
  • Biomedical RD
  • Digital Solutions
  • AI Solutions
  • Biological Sciences
  • Therapeutic Discovery
  • Detailoriented
  • Multitasking
  • Proactive
Job Description
As a Scientist (PhD level) specializing in Biomedical R&D, you will play a crucial role in revolutionizing the biomedical research cycle by leveraging digital and AI solutions to drive innovations in biological sciences. Your responsibilities will include: - Systematically classifying various domains and subdomains of the biomedical discovery research process. - Identifying opportunities for creating digital solutions to support biomedical research scientists. - Reimagining the biomedical research process and envisioning how innovative digital/AI platforms can transform biological science innovations. - Collaborating with software and AI teams to enhance their understanding of biomedical research processes and identify gaps that can be addressed with digital solutions. - Working closely with the digital tech team to develop digital solutions tailored for biological sciences. - Identifying key areas of biomedical commercial opportunities in alignment with the leadership. - Conducting routine market analysis to identify emerging business prospects and providing insights to ThinkBio leadership. - Managing associates and fostering a positive, team-oriented work culture. - Participating in cross-functional team meetings and presenting results effectively. Qualifications Required: - PhD in any branch of biological sciences with expertise in areas such as cell biology, genomics, biochemistry, and therapeutic discovery. - Profound understanding of biomedical research processes and innovations in biology and drug development. - Familiarity with a diverse range of experimental approaches. - Strong presentation skills demonstrated in scientific conferences and internal meetings. - Ability to thrive in a matrix work environment with diverse technical expertise. - Detail-oriented with excellent multitasking abilities in a fast-paced setting. - Proactive in identifying critical issues and opportunities beyond the obvious.,
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posted 2 months ago
experience3 to 7 Yrs
location
Kochi, Kerala
skills
  • Sales
  • Leadership
  • Team Management
  • Sales Strategy
  • Forecasting
  • Budget Planning
  • Relationship Building
  • Market Analysis
  • Presentation Skills
  • Healthcare Industry Knowledge
Job Description
As a Regional Sales Manager in the Pulmonary therapeutic segment in Kerala, your role is crucial in leading sales efforts and driving growth within specialized therapeutic areas. Your responsibilities will include: - Recruiting, training, coaching, mentoring, and motivating a team of Area Sales Managers (ASMs) and Territory Sales Managers (TSMs. - Developing strategies to achieve or exceed sales targets for the Pulmonary product portfolio. - Forecasting sales, planning budgets, analyzing performance, and identifying new business opportunities. - Building and maintaining relationships with healthcare professionals and Key Opinion Leaders (KOLs). - Planning and executing medical educational events for professional engagement. - Gathering feedback from KOLs to enhance brand adoption and product positioning. - Ensuring product availability through effective coordination with distributors, stockists, and retailers. - Overseeing the proper utilization of promotional materials in compliance with guidelines. - Maintaining accurate reports on sales performance, market share, customer insights, and prescription audits. - Presenting business reviews to senior management and ensuring adherence to company policies and regulatory requirements. Qualifications & Experience: - Graduate in Science, Pharmacy, or related field (MBA preferred but not mandatory). - 10-15 years of pharmaceutical sales experience, including 3-5 years as a Regional Sales Manager. - Proven expertise in Pulmonary therapeutic areas. - Strong leadership, analytical, communication, and team management skills. - Willingness to travel extensively within Kerala.,
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posted 1 week ago
experience10 to 14 Yrs
location
Karnataka
skills
  • Medical Writing
  • Clinical Research
  • Pharmacovigilance
  • Therapeutic Areas
  • Statistical Data Analysis
  • Process Improvement
  • Clinical Documents
  • Regulatory Documents
  • Vendor Oversight
  • Training Development
Job Description
Role Overview: As a Principal Medical Writer at GSK, you will be responsible for developing high-quality clinical and regulatory documents to support the mission of advancing healthcare and getting ahead of disease. You will collaborate with cross-functional teams to ensure the delivery of accurate, clear, and impactful content aligning with global regulatory standards. This role presents an exciting opportunity to enhance your expertise, lead projects, and make a meaningful impact on patients" lives. Key Responsibilities: - Independently lead preparation of complex clinical and post-market safety documents such as DSURs, PSURs/PBRERs, ACOs, PADERs/PAERs, RMPs, and responses to regulatory authority questions. - Provide oversight to co-authors or team of writers, ensuring the quality of their work. - Lead cross-functional teams in document preparation, including content strategy development, coordination of contributions, review schedule organization, and project timeline management. - Ensure the delivery of high-quality documents reflecting accurate interpretation of safety, clinical, and statistical data in alignment with regulatory requirements. - Mentor less experienced writers, deliver training on medical writing topics, and drive initiatives to enhance medical writing processes. - Contribute to vendor oversight as necessary. Qualifications Required: - Minimum of 10 years of advanced safety writing experience in the pharmaceutical domain, including summarization and interpretation of complex data and preparation of complex documents. - Profound knowledge of relevant regulatory guidance (e.g., ICH, GVP, FDA, EMA), cross-functional clinical research roles, and procedures. - Experience in multiple therapeutic areas to dive into new areas confidently without lead time. - Advanced understanding and application of statistical, regulatory, and medical communication concepts for writing complex safety documents. Additional Details of the Company: GSK is a global biopharma company with a purpose to positively impact the health of 2.5 billion people by the end of the decade. The company focuses on uniting science, technology, and talent to prevent and treat diseases with innovation in specialty medicines and vaccines. GSK's culture emphasizes being ambitious for patients, accountable for impact, and doing the right thing to deliver for patients, shareholders, and employees. If you are passionate about advancing healthcare, creating impactful medical documents, and contributing to GSK's mission, this Principal Medical Writer role based in Bangalore with a hybrid working model presents an excellent opportunity for you to make a difference. Apply today to join GSK in getting ahead of disease together.,
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posted 2 weeks ago
experience1 to 5 Yrs
location
Karnataka
skills
  • Communication skills
  • Pharmacovigilance
  • symposia
  • workshops
  • Excellent written
  • oral communication skills in English
  • Presentation skills at Scientific meetings
  • both verbal
  • written
  • Technical writing skills
  • Understanding of ICHGCP
  • internal SOPs
  • Scientific methods
  • experimental design
  • Networking with Health Care Practitioners
  • Planning
  • conducting CMEs
  • trainings
  • Feasibility assessment of research sites
  • Medical inputs into brand strategy
Job Description
You will be responsible for providing scientific and technical expertise of the highest standards for local medical information, including interactions with Key External Experts (KEEs) and Key Opinion Leaders (KOLs). Additionally, you will provide medical and scientific input and information for business strategy for the region. Key Responsibilities: - Develop and sustain credible networking with appropriate Health Care Practitioners (HCPs). - Plan, facilitate, and conduct CMEs, symposia, trainings, workshops, scientific meetings, speaker tours, and other product-specific campaigns. - Deliver scientific presentations with consistent messages for key products at various meetings. - Support scientific presentations at medical education meetings. - Understand and support Scientific Engagement (SE) activities as per Medical Plans. - Become an expert in oncology for GSK brands and associated activities. - Stay updated on scientific knowledge in oncology, GSK molecules, and their PI for effective on-label communications. - Support in the feasibility assessment of potential research sites, develop concept notes, proposals, budgets, and monitoring tools for field studies. - Provide medical inputs into the development and execution of brand strategy. - Support Named Safety contact in strengthening oncology Pharmacovigilance. - Ensure continuous self-learning in Pharmacovigilance. Qualifications Required: - Minimum Level of Education: MBBS with post-graduate qualification. - Preferred Level of Education: Post-graduate qualification in Pharmacology/Public Health. - Preferred Education Level Reason: To interact effectively with specialized HCPs. Job-Related Experience: - Excellent written and oral communication skills in English and the local language. - Experience presenting scientific topics in various settings. - Solid understanding of ICH-GCP principles and internal SOPs. - Ability to comprehend scientific methods and experimental design. - 1-2 years in the pharmaceutical industry, preferably in oncology therapy with a preference for Hemato-oncology. Other Job-Related Skills/Background: - Presentation skills at scientific meetings. - Effective communication skills, both verbal and written. - Technical writing skills. - Ability to stay updated with new developments. - Capacity to provide and receive constructive feedback. - Build and maintain relationships with colleagues. - Share knowledge with team members. - Collaborate effectively within a team to achieve common goals. - Contribute creative ideas for continuous improvement. - Develop strong relationships with key opinion leaders. --- **About the Company:** GSK is a global biopharma company focused on uniting science, technology, and talent to get ahead of disease together. Their purpose is to positively impact the health of 2.5 billion people by the end of the decade. GSK aims to prevent and treat diseases with innovation in specialty medicines and vaccines across therapeutic areas such as respiratory, immunology, inflammation, oncology, HIV, and infectious diseases. The company values creating an environment where employees can thrive and focus on delivering for patients, shareholders, and the community. **Inclusion at GSK:** As an inclusive employer, GSK encourages candidates to reach out if they require any adjustments during the recruitment process. Candidates can contact the Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss their needs. --- **Note:** GSK does not accept referrals from employment businesses/agencies without prior written authorization. If you receive unsolicited emails from email addresses not ending in gsk.com or job advertisements with suspicious instructions, please inform GSK at askus@gsk.com to verify the job's authenticity.,
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posted 1 month ago

Medical Writer

Jupiter Life Science Consulting
experience2 to 6 Yrs
location
Maharashtra
skills
  • Medical Communications
  • Proofreading
  • Therapeutic Areas
  • Content Development
  • Research
  • Client Communication
  • Strategic Planning
  • Medical Terminology
  • PowerPoint
  • Time Management
  • Communication Skills
  • Client Service
  • Scientific Content Management
  • Annotating
  • Fact Checking
  • Microsoft Office Suite
  • Organizational Skills
  • SelfMotivation
  • DetailOriented
Job Description
Role Overview: As a Medical Writer at Red Nucleus, you will work closely with the Medical Communications team to plan, create, proofread, annotate, and manage scientific content for assigned accounts across various therapeutic areas and target audiences. Your responsibilities will include leading individual projects, contributing to internal client strategy workshops, managing client communications, and providing strategic medical communication recommendations. Key Responsibilities: - Support the Medical Services Team with strategic planning, developing, writing, and editing materials to meet deliverable milestones - Deliver high-quality work in partnership with the Team Lead/Medical Director - Lead the development of assigned project(s) while meeting client expectations with Medical Director or Lead Account review - Conduct research, fact check, and secure references for assigned projects - Proofread and annotate work to comply with in-house, client, and/or American Medical Association (AMA) style guides - Assist with client regulatory submissions and join medical, legal, and regulatory review process - Work closely with Account Director and Medical Director to build client confidence in Red Nucleus service offerings - Apply creative and critical thinking skills to resolve problems or issues - Provide onsite support at key client meetings or events - Maintain current knowledge of industry trends, standards, and key medical topics and terminology Qualifications Required: - Advanced degree in pharmacy, pharmaceutical sciences, nursing, or biosciences preferred; relevant undergraduate degrees with experience will be considered - 2-3 years of clinical content development and writing experience in a medical communication agency setting preferred - Strong writing skills, medical terminology knowledge, and attention to detail - Proficiency in Microsoft Office suite, particularly PowerPoint - Strong organizational and timeline prioritization skills - Self-starter with the ability to work independently or as part of a team - Ability to travel occasionally for business purposes (15%-25%) - Potential for remote position or attendance at Yardley office Additional Company Details: At Red Nucleus, you can enjoy comprehensive benefits and wellness programs, generous paid time off, flexible work arrangements, and a people-first culture that fosters self-expression and diversity. The company also celebrates service anniversaries, holidays, diversity and inclusion events, project milestones, and supports community organizations that employees are passionate about. Ongoing programs and events are designed to bring the global team together for a collaborative work environment.,
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posted 2 months ago

Medical Advisor

Dr. Reddy's Laboratories
experience2 to 6 Yrs
location
Hyderabad, Telangana
skills
  • Research
  • Publications
  • Medical Education
  • Training
  • Strategic Thinking
  • Communication Skills
  • Collaboration
  • Analytical Skills
  • Interpersonal Skills
  • Medical Advisor
  • Medical Strategy
  • Patient Support Programs
  • Scientific Data Analysis
  • Regulatory Knowledge
  • Therapeutic Area Knowledge
  • Research Methodologies
  • Interpretation of Medical Data
  • Decision Making Skills
Job Description
Role Overview: As an experienced Medical Advisor at Dr. Reddys Laboratories Ltd., you will play a crucial role in providing the scientific foundation for the Therapeutic Area (TA) medical strategy. Your responsibilities will include managing various medical activities, engaging key thought leaders, overseeing the execution of the medical affairs plan, and contributing to the development of the Medical Affairs strategic plan for identified Therapeutic Area (TA) and products. Key Responsibilities: - Serve as a core scientific member of the cross-functional franchise team, providing the scientific foundation for the Therapeutic Area (TA) medical strategy. - Conceptualize and manage a wide range of medical activities aligned with the TA Medical strategy, including research, publications, medical education, and patient support programs. - Engage key thought leaders through medical affairs activities in line with the overall strategic plan. - Ensure optimal execution of the strategic medical affairs plan through Regional Medical Affairs, encompassing medical education, product education, and special projects. - Act as a therapeutic area scientific expert, discussing scientific data with leading specialists, and providing training on the latest medical developments to the sales and marketing team. Qualifications: - Educational qualification: MBBS with M.D. Pharmacology/Medicine or full-time post-graduate qualification in any discipline of medicine. - Minimum work experience: 2-4 years of experience in the pharmaceutical industry or research company in a Medical Advisor capacity. Skills & Attributes: Technical Skills: - Training in medical writing, clinical trial methodologies, research design, and ICH GCP will be an added advantage. - Must have a working knowledge of Indian regulations pertaining to Health care professionals interactions and Drugs and Cosmetic Act regulations. - Strong academic record with deep knowledge of the therapeutic area, research methodologies, and interpretation of medical data. - Strategic mindset with scientific acumen and communication skills. - Experience with complex business environments preferred. Behavioural Skills: - Integrity-driven decision-making skills. - Sound scientific knowledge. - Collaboration and teaming abilities. - Strategic thinking and sound analytical skills. - Intellectual curiosity. - Self-awareness and adaptability. - Result-oriented and performance-driven. - Excellent interpersonal and communication skills. Additional Details: Dr. Reddys Laboratories Ltd., a leading multinational pharmaceutical company, has a strong commitment to access, affordability, and innovation in the healthcare industry. With a focus on sustainability and future growth, the company aims to reach over 1.5 billion patients worldwide by 2030. The Global Generics India business has shown significant growth over the years, ranking among the top pharmaceutical companies in the Indian Pharma Market. For more information about Dr. Reddys and career opportunities, please visit our career website at https://careers.drreddys.com/#!/.,
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posted 3 weeks ago

Statistical Programmer

Latinum HR Solutions
experience3 to 12 Yrs
location
Hyderabad, Telangana
skills
  • SAS programming
  • R
  • CDISC standards
  • Regulatory submissions
  • Communication skills
  • Leadership skills
  • Clinical study lifecycle
  • Therapeutic areas knowledge
Job Description
Role Overview: You are an experienced Lead Statistical Programmer responsible for overseeing programming activities for clinical trials, regulatory submissions, and integrated analyses. Your role involves leading a team, ensuring high-quality deliverables, and developing efficient programming standards to support drug development. Key Responsibilities: - Lead statistical programming activities for a compound or therapeutic area. - Manage, mentor, and guide a team of statistical programmers. - Create and validate analysis data sets (ADaM), tables, listings, and figures (TFLs) following CDISC standards. - Develop and validate Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) reports. - Ensure accuracy and consistency across clinical studies and integrated data. - Develop, test, and implement reusable standard programs and SAS macros to automate routine tasks. - Prepare reviewer guides, data definition documents, and other materials for regulatory filings. - Collaborate with cross-functional teams including Statisticians, Clinical Data Management, Medical Writing, Regulatory, and Clinical Operations. - Accurately estimate programming efforts and ensure timely project delivery. Qualifications Required: - Strong proficiency in SAS programming; experience with R preferred. - In-depth knowledge of CDISC standards (ADaM, SDTM). - Experience with regulatory submissions (FDA, EMA) and clinical study lifecycle. - Knowledge of therapeutic areas such as Oncology, Immunology, Neuroscience. - Strong communication and leadership skills to guide teams and manage stakeholders. - Ability to handle multiple priorities and deliver high-quality results under deadlines.,
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posted 2 months ago
experience3 to 7 Yrs
location
Maharashtra
skills
  • Collaboration
  • Stakeholder Engagement
  • Compliance Management
  • Product Launch
  • Customer Relationship Management
  • Scientific Engagement
  • Value Cocreation
  • Patient Needs
  • Medical Strategy
  • Therapeutic Area Knowledge
  • Healthcare Systems Strengthening
  • Ethics
  • Compliance
Job Description
Role Overview: As a Medical Science Liaison (MSL) at Alkem Laboratories Limited, you will play a crucial role in scientifically engaging, collaborating, and aligning with various external stakeholders to create value, address patient needs, and enhance the practice of medicine for improved patient access and outcomes. Your responsibilities will include leveraging scientific evidence during engagements, identifying impactful insights, contributing to product strategy, generating evidence plans, and collaborating with field matrix colleagues to support healthcare systems strengthening. Key Responsibilities: - Act as a strategic scientific partner by gathering insights for Patient Journey mapping, launch excellence roadmap, and integrated evidence generation plans - Serve as a Medical, Clinical, and Scientific expert on assigned therapeutic areas and Alkem Laboratories Ltd. compounds - Identify and map external stakeholders aligned with the medical strategy, and establish innovative partnership models for transforming clinical practice - Communicate relevant evidence to stakeholders in a timely manner to facilitate informed decision-making - Respond to unsolicited information requests from stakeholders regarding marketed and pipeline compounds - Manage administrative tasks efficiently, including customer relationship management, compliance training, and expense reporting - Travel nationally to engage with Key Opinion Leaders (KOLs) regularly, especially during new product launches - Play a key role in internal customer connections and contribute to equity and revenue building efforts - Promote and adhere to Ethics and Compliance Professional Practices Policy Qualifications Required: - Qualified Medical Professional with MBBS, BAMS, or BDS degree - Pharmacists, individuals with a Master's or post-graduate degree in health/life sciences are encouraged to apply; Doctoral degree (MPharm, PharmD, PhD) preferred,
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posted 3 weeks ago
experience1 to 5 Yrs
location
All India
skills
  • Communication skills
  • Pharmacovigilance
  • symposia
  • workshops
  • Excellent written
  • oral communication skills in English
  • Presentation skills at Scientific meetings
  • both verbal
  • written
  • Technical writing skills
  • Understanding of ICHGCP
  • internal SOPs
  • Scientific methods
  • experimental design
  • Networking with Health Care Practitioners
  • Planning
  • conducting CMEs
  • trainings
  • Feasibility assessment of research sites
  • Medical inputs into brand strategy
Job Description
As a Medical Scientific Expert at GSK, your main role will be to provide scientific and technical expertise for local medical information, including interactions with Key External Experts (KEEs) and Key Opinion Leaders (KOLs. You will also be responsible for providing medical and scientific input for business strategy in the region. **Key Responsibilities:** - Develop and maintain networking with Health Care Practitioners (HCPs). - Plan, facilitate, and conduct various scientific events and campaigns. - Deliver scientific presentations with consistent messages for key products. - Support and present at medical education meetings. - Understand and support Scientific Engagement activities. - Become an expert in oncology for GSK brands. - Stay updated on scientific knowledge related to oncology and GSK molecules. - Support in feasibility assessment of research sites and development of proposals. - Provide medical inputs for brand strategy. - Support oncology Pharmacovigilance efforts. **Qualifications Required:** - Minimum MBBS with post-graduate qualification. - Preferred post-graduate qualification in Pharmacology/Public Health. - Experience in presenting scientific topics and understanding ICH-GCP principles. - 1-2 years of experience in the pharmaceutical industry, preferably in oncology. At GSK, we aim to positively impact the health of 2.5 billion people by the end of the decade. We focus on specialty medicines and vaccines in therapeutic areas such as respiratory, immunology, oncology, HIV, and infectious diseases. Our culture emphasizes being ambitious for patients, accountable for impact, and doing the right thing. Join us in uniting science, technology, and talent to get ahead of disease together. Inclusion is a core value at GSK, and we encourage candidates to reach out for any necessary adjustments during the recruitment process. If you need any accommodations, please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com. Please note that GSK does not accept referrals from employment businesses/agencies without prior authorization. Any unsolicited email or job advertisement not from an address ending in gsk.com should be disregarded. Kindly inform us at askus@gsk.com if you encounter any suspicious emails.,
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posted 2 months ago
experience2 to 6 Yrs
location
Maharashtra
skills
  • Product promotion
  • Distribution network management
  • Team management
  • Product knowledge
  • Communication
  • Relationship building
  • Inventory management
  • Compliance management
  • Attrition control
  • Forecasting
  • Budgeting
  • Budget achievement
  • Customer needs understanding
  • Process execution
  • Coaching Mentoring
  • Detailing effectiveness
  • Influencing
  • Market share growth
  • Training
  • recruitment
  • Meeting organization
  • CF control
  • Feedback reporting
  • Sales data analysis
  • CME
  • RTMs
  • Nutrition brand handling
  • Cardio Diabetic segment handling
  • Good communicator
Job Description
As an Area Nutrition Manager / Area Business Manager for the Adult Nutrition Team, your role will involve the following responsibilities: - Ensuring 100% budget achievement (Therapy wise/Product wise/Brand wise) with the proper utilization of available manpower and product promotion. - Managing the distribution network effectively. - Understanding customer needs and executing processes such as RCPA, Doctor Call, Doctor Coverage, CRM, and Strategy Implementation. - Leading and coaching a team of Nutrition Officers (Medical Representatives) through on-the-job training, focusing on product knowledge, detailing effectiveness, communication, influencing, and relationship building. - Driving focused brand performance and managing inventory at the distributor level. - Ensuring 100% compliance with company strategies and increasing the market share of the therapeutic segment and products. - Consistently growing the market, controlling attrition, conducting training and recruitment, organizing meetings, forecasting, budgeting, and managing C&F. - Providing periodic feedback to Senior Managers on team performance, reporting status of activities implementation, and analyzing sales data. - Coordinating CME and RTMs effectively. Candidate Profile: - Candidates with exposure to handling nutrition brands will be preferred. - If no exposure in nutrition, candidates should have experience in handling segments like Cardio Diabetic. - Candidates should have 2-4 years of experience in a similar capacity, with good communication skills and exposure to team handling. Qualifications: - B.Pharma, D.Pharma, B.SC. in Life Sciences Experience: - For External Candidates: 2-3 years as an Area Manager - For Signutra Employees: 3-5 years as a Medical Representative and at least 1 year with Signutra This role will cover the areas of Vashi, Thane, Kalyan, Panvel, Baroda, and Goa.,
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posted 3 weeks ago
experience2 to 6 Yrs
location
Hyderabad, Telangana
skills
  • compliance
  • therapeutic areas
  • regulatory requirements
  • content management
  • written communication
  • verbal communication
  • oncology
  • cardiovascular
  • inflammation
  • bone
  • rare diseases
  • scientific accuracy
  • data accuracy
  • reference appropriateness
  • compliance awareness
  • scientific expertise
  • attention to detail
  • medical context
  • scientific balance
  • review practices
  • US compliance
  • copyright requirements
  • transferofvalue requirements
Job Description
As the Scientific Communications MLR Technical Reviewer at the company, your role involves checking all medical content for data and scientific accuracy, and reference appropriateness for materials submitted through the Medical, Legal, and Regulatory (MLR) process. It is your responsibility to ensure that all content aligns with Amgen's scientific and compliance standards, facilitating timely review and approval of assets that educate and engage healthcare providers, patients, and internal stakeholders. Working in collaboration with the US Scientific Communications MLR Reviewer, your scientific expertise, attention to detail, and compliance awareness play a crucial role in evaluating submissions and maintaining the quality and consistency of Amgen's communications. **Roles & Responsibilities:** - Conduct a review of proactive materials for scientific accuracy and reference appropriateness - Review the material to ensure appropriate medical context, scientific balance, and compliance are maintained - Ensure timely and high-quality review of MLR materials within established SLAs and agreed-upon timeframes - Collaborate with the US Scientific Communication MLR Reviewer to provide clear guidance on action items - Work within Amgen's MLR systems to apply clear review comments per company process - Conduct and participate in knowledge-sharing sessions to align on therapeutic areas, products, and review best practices - Provide scientific guidance to cross-functional teams regarding appropriate interpretation and use of data in promotional and medical content - Support standardization of review practices, templates, and criteria to enhance efficiency and consistency across reviews - Stay current on therapeutic area developments, industry guidelines, and regulatory requirements relevant to MLR reviews - Contribute to process improvement initiatives and adoption of new technologies that enhance review workflows **Basic Qualifications and Experience:** - Doctorate degree & 2 years of directly related experience OR - MBBS or Masters degree & 4 years of directly related industry experience OR - Bachelors degree & 4 years of directly related industry experience OR - Associates degree & 6 years of directly related industry experience **Functional Skills:** - Doctorate degree in life sciences, pharmacy, biomedical sciences, or a related field - 5+ years of experience in medical review, medical writing, scientific communications, publications, or related industry role - Familiarity with the MLR review process and regulatory requirements for medical and promotional materials - Strong ability to critically evaluate data, references, and claims for scientific accuracy and compliance - Prior experience with content management and MLR review systems (e.g., Veeva PromoMats or equivalent) - Excellent attention to detail and organizational skills to manage multiple, concurrent submissions under tight timelines - Strong written and verbal communication skills to interact effectively with cross-functional stakeholders - Knowledge of therapeutic areas such as oncology, cardiovascular, inflammation, bone, and rare diseases is a plus - Understanding of US compliance, copyright, and transfer-of-value requirements **Competencies:** - Scientific Integrity: Upholds rigorous standards in data accuracy and interpretation - Collaboration: Works effectively with cross-functional global teams in MLR review cycles - Attention to Detail: Ensures consistency, accuracy, and compliance in content review - Time Management: Prioritizes high-volume review workload and meets critical deadlines - Adaptability: Adjusts to evolving review practices, systems, and regulatory expectations - Compliance: Demonstrates commitment to integrity in all aspects of review work Please note that the company is committed to providing reasonable accommodations for individuals with disabilities during the job application, interview process, essential job functions, and other benefits and privileges of employment. Feel free to reach out to request accommodation if needed.,
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posted 2 months ago

Clinical QC editors and Nonclinical writers

Freyr Software Services Private Limited
experience3 to 7 Yrs
location
Hyderabad, Telangana
skills
  • Quality Control
  • Clinical Data
  • Therapeutic Areas
  • Pharmacology
  • Pharmacokinetics
  • Toxicology
  • Project Management
  • Regulatory Documents
Job Description
You will be responsible for performing comprehensive Quality Control (QC) review of clinical sections of regulatory documents to ensure the highest quality from technical, regulatory, and compliance perspectives. This includes verifying all references and source data, ensuring internal consistency within documents, and documenting QC findings appropriately. Additionally, you will be involved in content QC of clinical data/reports across different therapeutic areas, development phases, modalities, and geographic regions. - Conduct comprehensive QC review of clinical sections in regulatory documents such as IBs, INDs, NDAs, BLAs, CTAs, MAAs, and briefing packages for regulatory agency meetings. - Verify data presented in text, tables, and figures against source documents for consistency and accuracy. - Ensure 100% verification of data/content as per the source documents. - Review documents for grammar, punctuation, spelling, and compliance with specified styles/standards. - Maintain QC records and checklists. - Hands-on experience in regulatory toxicology and writing of Non-clinical Regulatory/Non-Regulatory documents. - Proficiency in drafting and reviewing Modules 2.4 and 2.6 (pharmacology, pharmacokinetics, and toxicology) for regulatory submissions. - Good knowledge of pharmaceutical impurities, degradation products, and excipients in the context of nonclinical writing. - Experience in content QC, including checking and verifying data presented in text, tables, and figures against source documents. - Project management skills and ability to work closely with cross-functional teams. - Familiarity with attending cross-functional project calls and managing due diligence activities. - Technical review experience of submission output and operational support activities in a non-clinical setting.,
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posted 2 weeks ago

Manager Content

Abbott Laboratories
experience10 to 14 Yrs
location
Maharashtra
skills
  • Medico Marketing
  • Content Writing
  • Copywriting
  • Visualization
  • Therapeutic Areas
  • Communication Skills
  • Research
  • Brand Communication
  • Marketing Strategy
  • Healthcare Communications
  • Clinical Understanding
  • Customer Insights
Job Description
Role Overview: As a Manager Medico Marketing Content Writer at Co. Create, Abbott's in-house creative agency in Mumbai, you will play a crucial role in translating complex clinical and scientific information into clear, engaging, and compliant content for various healthcare communications. Your primary responsibility will be to develop promotional and educational materials for healthcare professionals (HCPs), patients, and the public, ensuring alignment with industry regulations and brand strategy. Key Responsibilities: - Interpret client briefs and understand content/creative requirements, timelines, and target audience expectations - Develop content for a wide range of marketing materials for HCPs, including Brand Promise, Brand taglines, Visual Aids (VA), Leave-Behind Literature (LBL), Patient Education Leaflets, Video scripts, Gamification content, and Therapy shaping - Collaborate with marketing, creative, and client servicing teams to ideate and visualize concepts, delivering high-quality copy tailored to each creative asset - Serve as the single point of contact for all medical content and copy-related communication - Demonstrate versatility in writing styles and tones to suit varied formats and audiences - Maintain impeccable grammar, spelling, and adherence to brand voice - Exhibit deep understanding of target groups and therapeutic domains - Conduct thorough research, apply strong organizational and learning skills, and ensure all outgoing communication is medically accurate, brand-aligned, and quality-checked - Manage, guide, and mentor a content team of 3, consisting of both creative and medical writers Qualification Required: - Educational Qualifications: MBBS, BAMS, or B. Pharm (Bachelor of Pharmacy) Additional Details: Co. Create is Abbott's in-house creative agency based in Mumbai, emphasizing collaboration, a holistic perspective, and effectiveness in their approach to content creation. The team comprises visionary content creators, designers, problem solvers, tech enthusiasts, and passionate collaborators who believe in the power of integrating content, strategy, and creativity. With a focus on staying up to date with technology and fostering curiosity, the agency aims to create impactful stories that resonate with clients" core values and connect with their target audiences effectively.,
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posted 3 weeks ago
experience6 to 10 Yrs
location
Hyderabad, Telangana
skills
  • peer support
  • project management
  • stakeholder management
  • interpersonal skills
  • problem solving
  • policy management
  • project management
  • cultural sensitivity
  • compliance standards
  • timelines management
  • quality expectations
  • therapeutic area teams coordination
  • SOP adherence
  • congress
  • launch readiness support
  • material review
  • release
  • training
  • guidance
  • submission readiness reviews
  • compliance review
  • system tasks monitoring
  • system delegations maintenance
  • readiness checks
  • organizational skills
  • multitasking skills
  • global collaboration
Job Description
**Job Description:** As a Senior Manager Content Approval Coordination at Novartis, you will play a crucial role in ensuring the end-to-end execution of the content approval process for both non-promotional and promotional materials within Global Medical Affairs (GMA). Your responsibilities will include leading submission readiness reviews, managing and facilitating the full content approval process, providing guidance to project owners and vendors/agencies, and ensuring final approved materials are appropriately documented. You will also be responsible for conducting Readiness Checks, updating/maintaining system delegations, and communicating and managing team expectations on status, volume, and prioritization. **Key Responsibilities:** - Lead submission readiness reviews in the content review process and monitor project status. - Manage and facilitate the full content approval process for both non-promotional and promotional materials. - Work with internal and external stakeholders to plan and route materials for timely compliance review. - Provide guidance to project owners and vendors/agencies on submission requirements. - Ensure final approved materials are appropriately documented and communicate team expectations. **Qualifications Required:** - Over 6 years of professional experience in the pharma industry. - Experience with reviewing or approving business promotional and non-promotional material. - Strong knowledge of compliance and regulatory requirements in the pharmaceutical industry. - Experience managing an external service partner. - Excellent interpersonal skills and ability to develop trusting relationships with stakeholders. - Strong analytical, problem-solving, organizational, and project management skills. At Novartis, we are committed to building an outstanding, inclusive work environment and diverse teams that are representative of the patients and communities we serve. Join us in our mission to reimagine medicine and improve lives. To learn more about our people and culture, visit: [Novartis People and Culture](https://www.novartis.com/about/strategy/people-and-culture) Please note that Novartis is committed to providing reasonable accommodation to individuals with disabilities. If you require accommodation during the recruitment process, please contact [email protected] with your request. --- *Note: The additional details of the company, such as commitment to diversity and inclusion, benefits, and rewards, have been omitted for brevity.,
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posted 2 months ago

Medical Writer

MOLECULAR CONNECTIONS
experience2 to 6 Yrs
location
Karnataka
skills
  • writing medico marketing content
  • working with KOLs
  • understanding of therapeutic areas
  • preparation of medico marketing supports
  • poster writing
  • medical training content
  • product storyboard monographs
  • CME deck
Job Description
Role Overview: You should have expertise in writing medico marketing content and a minimum of 3-5 years of experience in creating medico marketing materials for global/domestic pharmas. You must be able to work with KOLs and key decision makers, and have a strong understanding and knowledge of various therapeutic areas. Your content expertise should include preparation of medico marketing supports, poster writing, medical training content, product storyboard monographs, and CME deck. Key Responsibilities: - Write medico marketing content - Create medico marketing materials for global/domestic pharmas - Collaborate with KOLs and key decision makers - Demonstrate understanding and knowledge of various therapeutic areas - Prepare medico marketing supports, poster writing, medical training content, product storyboard monographs, and CME deck Qualifications Required: - MBBS or Pharm D or MD Pharmacology and PhDs - Minimum 2 years of experience; Maximum 3 years of experience,
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posted 2 months ago
experience3 to 7 Yrs
location
Maharashtra
skills
  • Medical Affairs
  • Therapeutic Area
  • Scientific Writing
  • Medical Education
  • Regulatory Affairs
  • Pharmacovigilance
  • MedicoMarketing
  • Key Opinion Leader Development
Job Description
Role Overview: As a Medical Affairs Executive, your primary responsibility is to understand current practices, medicines, and trends in the respective therapeutic area by engaging in doctor visits, attending scientific symposia, and reviewing key therapeutic journals. This knowledge will enable you to provide valuable information to both internal and external customers. Key Responsibilities: - Publish scientific articles related to company products. - Create presentations for doctors for Continuing Medical Education (CME) sessions and product launches. - Participate in implementing the medico-marketing strategy. - Conduct regular field visits to doctors for product management and Key Opinion Leader (KOL) development. - Approve Labelling (LBLs), Visual Aids (VA), product monographs, and other medico-marketing content for product promotion. - Provide product rationale and clinical data for new products/indications. - Assist regulatory affairs with pack inserts (PI) and other medical data approvals as needed. - Generate Periodic Safety Update Reports (PSURs) and update dates for the next PSUR with tracking sheets as part of pharmacovigilance.,
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posted 2 months ago

Manager Medical Advisor

Intas Pharmaceuticals
experience3 to 7 Yrs
location
Gujarat, Ahmedabad
skills
  • Medical Marketing
  • Therapeutic Areas
  • Product Strategy
  • Medical Education
  • Training
  • Medical Support
  • Key Opinion Leaders KOLs
  • Scientific Initiatives
  • Advisory Board Meetings
  • Healthcare Professionals HCPs
  • MedicoMarketing
Job Description
As a Medico Marketing professional at Intas Pharmaceuticals, your role will involve handling the medico marketing responsibilities of the assigned business unit/s. Your primary objective will be to provide internal medical and scientific support to the designated therapeutic areas. You will contribute to product/therapy strategy, engage with key customers including national Key Opinion Leaders (KOLs), and facilitate various scientific initiatives like advisory board meetings, scientific symposia, and medical education sessions. Key Responsibilities: - Serve as an internal medical and scientific resource for assigned therapeutic areas - Assist in devising Product/Therapy Strategy - Provide medical/clinical oversight for positioning strategy and implementation tactics of respective products - Screen relevant literature and information from scientific society meetings to develop key message summaries - Stay updated on new developments, publications, and trends in different therapy areas - Collaborate with Business Development to identify new molecules and drug delivery systems aligning with business needs - Identify, develop, and maintain relationships with national KOLs and other key customers - Engage with Healthcare Professionals (HCPs) to address scientific, product, and therapy area related queries - Present scientific information to HCPs, ensuring medical accuracy and compliance with ethical guidelines - Conceptualize, coordinate, and execute advisory board meetings - Conduct scientific presentations, medical education sessions, and coordinate scientific initiatives - Contribute to training on therapy/product updates for the therapy management team and Field Force team - Support team handling in medico-marketing activities Qualification Required: - Medical graduate/Postgraduate (MBBS/MD/MS) with a Management qualification Intas Pharmaceuticals is a leading global pharmaceutical company known for its high standards of quality and commitment to addressing unmet medical and societal needs. With a presence in over 85 countries worldwide, Intas has a strong focus on innovation, excellence, and talent development. The company's success is attributed to its people, who are encouraged to foster innovation and drive growth in the global healthcare sector. Note: Travel required for the role is between 25% - 50%.,
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posted 1 week ago
experience5 to 9 Yrs
location
Hyderabad, Telangana
skills
  • Pharmacovigilance
  • Pharmaceutical Industry
  • Risk Management Plans
  • Project management
  • Regulatory submissions
  • Interpersonal skills
  • Clinical overview
  • Clinical documents
  • Collaborative writing
  • FDA regulations
  • EMA regulations
  • ICH guidelines
  • Good Clinical Practices
  • Drug development process
  • Therapeutic Area experience
Job Description
As a Senior Manager of Benefit Risk Assessment Operations at Bristol Myers Squibb, you will be responsible for collaboratively authoring and revising key drug safety-focused documents to support upcoming submission documents to Regulatory Health Authorities worldwide. Your role will involve working closely with various cross-functional stakeholders in BMS to prepare accurate and concise safety information for the development of new treatments and post-marketing safety activities. **Principal Responsibilities:** - Attend meetings related to structured benefit risk assessment (SBRA) to understand approaches and contribute to discussions. - Schedule and facilitate meetings to discuss risk management strategy and support the authoring of various risk management documents. - Produce detailed timelines for Core SBRA document and ensure alignment with Clinical overview timelines. - Project management to ensure timelines are met, follow-up on deliverables, and author/edit sections based on source documents. - Manage documents for review, adjudicate comments, facilitate approvals, and ensure compliance with BMS style guide. - Support authoring and formatting of risk management documents, coordinate with stakeholders, and communicate updates to internal stakeholders. - Ensure consistency in information presented in program documents and perform quality reviews to maintain high standards. - Produce documents in accordance with internal SOPs and guidelines. **Required Qualifications by Level:** - PharmD/PhD or equivalent with a minimum of 5 years" experience in Pharmacovigilance/Pharmaceutical Industry. - Thorough understanding of requirements for complex strategic documents and PBRER. - Strong experience in Clinical overview and Clinical documents. **Preferred Qualifications:** - Experience with Risk Management Plans and Clinical Overviews. - Collaborative writing experience and strong project management skills. - Knowledge of FDA and EMA regulations, ICH guidelines, and drug development process. - Proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat. - Prior Therapeutic Area experience in oncology, cell therapy, hematology, etc. - Interpersonal skills for a collaborative team environment. If you are intrigued by this role and believe you can contribute, we encourage you to apply regardless of how closely your experience aligns with the requirements. Bristol Myers Squibb offers a supportive work environment where every employee plays a vital role in transforming patients" lives through science.,
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posted 2 months ago
experience3 to 7 Yrs
location
Maharashtra, Pune
skills
  • Primary Market Research
  • Data Analysis
  • Client Management
  • Project Management
  • Innovation
  • Qualitative Research
  • Quantitative Research
  • Survey Design
  • Analytical Skills
  • Communication Skills
  • Presentation Skills
  • Excel
  • PowerPoint
  • Therapeutic Areas
  • Oncology
  • Data Privacy
  • English
  • Industry Expertise
  • Market Research Design
  • Indepth Interviews
  • Survey Questionnaire Development
  • Compliance Policies
Job Description
As a Consultant in Primary Market Research at PharmaACE, a growing Global Healthcare Consulting Firm based in Princeton, New Jersey, you will play a vital role in designing and executing high-quality primary research for leading global pharmaceutical clients. Your responsibilities will include market research design, data analysis, client management, project management, industry expertise, and innovation. Key Responsibilities: - Develop and implement primary market research strategies tailored to address specific business objectives of clients. - Design qualitative and quantitative research studies such as surveys and in-depth interviews. - Analyze primary data to identify trends, behaviors, and actionable insights. - Translate research findings into strategic recommendations for clients. - Provide support to a leading global pharmaceutical client and internal stakeholders in an offshore setting. - Manage multiple projects concurrently, ensuring on-time delivery within budget and scope. - Keep updated on market trends, therapeutic areas, and regulatory developments within the pharmaceutical and healthcare sectors. Qualifications Required: - MBA Marketing with a Graduation degree in Life Sciences or Pharmaceutics / MBA Pharma / M Pharma. - Minimum 3 years of relevant job experience. - Proficiency in Excel and PowerPoint. - Strong analytical, communication, reporting, and presentation skills. - Understanding and experience of the US pharmaceutical market scenario. - Background knowledge in multiple therapy areas, particularly oncology, is advantageous. - Experience in developing and programming survey questionnaires or discussion guides is desirable. - Ability to create impactful PowerPoint presentations based on survey data. - Adherence to client-specific data privacy and compliance policies. - Fluency in English is essential.,
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