Responsibilities Maintain effective relationship with the end stakeholders (medical scientific community) within the allocated Global Business Unit and product – with an end objective to develop education and communication content as per requirement; (2) Interact effectively with health care professionals on publication content; and (3) Constantly assist other writers in developing knowledge and sharing expertise Performance: (1) Provide publication/medical education material (slide deck, abstract, poster, manuscript etc.) as per agreed timelines and quality and (2) Provide strategic support with individuals and institutions, which may serve as resources for publications purpose Process: (1) Develop complex publication/medical education material; (2) Support medical communication and develop subject matter expertise for the assigned therapeutic area; (3) Assist the assigned scientific communication team in conducting comprehensive publication-need analysis; (4) Implement relevant element of publication plan and associated activities for the year identified for the region; (5) Work with selected vendors within the region to deliver the required deliverables as per defined process; and (6) Design an overall plan of action based on end-user feedback and improve course content and delivery Stakeholder: (1) Work closely with scientific communication teams in regions/areas to identify publication need and assist in developing assigned deliverables and (2) Liaise with Product Managers, MSLs, medical department to prepare relevant and customized deliverables     Qualification & Experience Experience: ≥2 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: As applicable (including but not limited to therapeutic area/domain knowledge exposure; publication submission; and/or project management) Education: Advanced degree in life sciences/pharmacy/similar discipline or medical degree  

Responsibilities Represent GRA CMC CHC in Global cross-funtional teams and meetings, partners with the leaders of these teams to facilitate successful product development and life cycle management Develop global regulatory CMC strategies for products in re-development phase (within health care products: chemical and biological entities, herbals; drugs, devices) as well as during maintenance. CMC regulatory contribution to CHC´s Clean Ingredients´ and Sustainability Roadmap Plan submissions and CMC dossier/package strategies according to the product’s global CMC regulatory strategy for CTA/INDs, MAAs, international MAs, HA meetings, maintenance submissions, change amendments/supplements, commitments, etc. Provide accurate and timely regulatory CMC assessments and expertise input to cross-functional teams´ recommendations Communicate project plans, status and updates to management Facilitate together with the CMC teams and regional/local regulatory experts the planning and execution of regulatory actions (submissions, Health Authority (HA) meetings, etc.) Coordinate and support dossier preparation, review and publishing process in line with project timelines. Ensure high quality global filings with timely approvals. Manage regulatory databases for planning and tracking of regulatory submissions. Assure that, for major CMC activities with a critical regulatory and/or financial impact, risks are identified, communicated, and mitigated as needed. Assure that positive and collaborative relationships are developed with CMC/Manufacturing & Supply teams to achieve successful implementation in accordance with project planning. Initiate required Health Authority meetings in collaboration with Country Regulatory Teams, and conduct them in an effective manner, whilst developing positive and favorable relationships. Lead the Regulatory CMC content of HA meetings as Subject Matter Expert. Support strategic negotiations with worldwide Regulatory Health Authorities so that appropriate and pragmatic positions are negotiated with the highest Probability of Success (POS) CMC regulatory contribution/review and expert recommendation to the CMC writer within Development Units and Manufacturing & Supply Organisation. Due Diligence of regulatory CMC dossiers. CMC Regulatory Intelligence: Contribute to Regulatory Science and Policy activities as well as other internal or external policy initiatives related to CMC regulatory topics. Monitor the review of local and international Health Authority regulations and guidelines, contribute to the commenting process and/or develop position papers. Assure that current Health Authority thinking, and trends (paradigm shifts) are understood and broadly communicated. As applicable, support of Health Authority inspections for Global CMC Regulatory questions     Qualification & Experience Bachelor in a science/health field (e.g.: Pharmacy, Analytical / Chemistry, Biological/Biotechnology Sciences etc.), or equivalent; Advanced degree (Master, PhD) is preferred Global Regulatory CMC experience minimum 2-3 years. Candidates with additional technical pharmaceutical CMC experience (laboratory, development, manufacturing, etc.) will be preferred. Demonstrated experience in developing regulatory CMC strategies for medicinal products Knowledge / experience of CMC requirements for Probiotics, Food Supplements and Medical Devices will be great advantage. Experience working for a Regulatory Health Au

Responsibilities Manage a team of auditors located in Hyderabad (India) and coordinate the activity. Conduct GxP audits (CHC sites, Development Centres, country offices, CDMOs and Suppliers) mainly in AMEA (Africa, Middle East, Asia) region (significant part of the time dedicated to international travels). Support the worldwide auditor’s team as necessary. Prepare audits and issue audit reports in a timely manner. Conduct Global transversal assessment audits. Approve / Manage audit CAPA to agreed timelines. Ensure adherence to audit metrics and internal departmental SOPs for the region. Ensure the effectiveness of the implementation of Sanofi/Opella Quality standards and procedures. Keep up to date with current and forthcoming regulatory authority requirements, and relevant Sanofi/Opella Global Quality documents. Effectively evaluates compliance with these requirements at Opella entities and third parties and identifies ways for these entities to increase their level of compliance. Together with the Inspection coordinator, support the preparation and follow-up of Regulatory Inspections for GxP activities in the AMEA region as required. Ensure the onboarding, training and certification of the Global Quality auditors in the region and globally as needed. Provide expertise on GxP requirements to the entities in the AMEA region. Organize communications / meetings / Training with the Quality network in the AMEA region as necessary.     Qualification & Experience Experience: 10+ years working experience in Quality management and auditing in Pharmaceutical Industry. Pharmacist or advanced degree (e.g., Master, PhD or equivalent) in life sciences or related fields Excellent knowledge of GXP regulations and pharmaceuticals standards for a wide range of products (CHC Drug Products, Neutraceutical, Cosmetics, Medical Devices) Be a qualified auditor, minimum experience of 10 years in a GMP/GDP environment.  

Responsibilities Perform formulation development activities on differentiated formulations and innovative technologies to achieve Product development with adherence to timelines while ensuring good lab and documentation practices. Carry out /Support Scientific literature search (Articles/patents/publications/books) and compilation of experimental data, which will facilitate decision making to achieve Product development. Perform Formulation optimization with special focus on manufacturability and biopharmaceutical properties of drug products to achieve successful commercial drug product. Carryout & Support Writing and Review of protocols, reports, validation plans and development report to achieve product development in compliance to quality systems. Coordinate with CFT’s and timely escalation to ensure document approvals on time. Support drug product ideation and selection activities with technical due diligence with appropriate development approaches and assessing timelines. Coordinate outsourced activities at the partner site by a regular communication plan. Provide timely technical inputs and timely escalation to ensure successful task completions. Support in preparing formal correspondence with regulatory agency to get clarity for focused efforts. Support in preparing milestone wise timelines for the allocated programs. Ensure timely execution and delivery of each program milestones and minimize the slippages. Ensure the activities are carried out in compliance with various quality, regulatory and EHS norms. Support and coordinate application of various regulatory licenses required for R&D, clinical, import activities. Ensure timely availability of such licenses. Support in Developing, maintaining, and upgrading lab facility and support facility team to maintain and run lab effectively. Support in Technical troubleshooting/ root cause identification/ Investigation/Corrective Action and Preventive Action pertaining to product development or manufacturing activities.     Qualification & Experience M. Pharm or Ph.D. in Pharmacy with minimum industrial experience of 3 to 7 years in pharmaceutical development and scale-up of products. Preferred area of expertise is Modified Release Oral Dosage forms and/or Immediate Release Oral Suspensions/Solutions. Global Product Development Experience is preferred while the core area should be the US. Experience of developing branded and differentiated products – 505(b)(2) category would be preferred. Experience of working with CROs/CDMOs would be preferred.  

Responsibilities Represent Regulatory Affairs and is responsible for articulating regulatory strategy including regulatory advocacy for development and post approval change activities. Serve as primary interface with FDA and other regulatory agencies. Review all the technical submission documents and provide regulatory feedback to ensure completeness, accuracy, and regulatory compliance. Manage regulatory filings (IND, PIND, Pre-NDA, Pre-ANDA, CGT, PFC, iPSP, Controlled Correspondences, NDA, ANDA, ODD etc.), including authoring scientific briefing book packages, eCTD sections in accordance with regulatory guidelines, applicable federal laws, and statutory requirements. Manage operational aspects of preparing compliant submissions to regulatory agencies. Establish and manage timelines associated with regulatory submissions in alignment with business priorities. Manage and address deficiencies (IR, DRL and CRL) received from FDA within pre-defined timelines, with adequacy and accuracy in consultation with stakeholders. Responsible for managing and tracking regulatory-related changes. Responsible for evaluating post approval change controls as per the regulatory agency guidelines to determine the appropriate reporting category and explicitly defining the necessary conditions and documents needed to implement the change. Manage archival of regulatory submissions, contact reports and correspondence logs. Provide regulatory guidance on requirements for development projects, as required. Keep abreast of current regulations and regulatory guidance, assessing impact to assigned projects and internal processes. Participate in various activities of setting goals, tracking deliverables and process improvements within the regulatory department. Develop collaborative and respectful relationships with internal and external partners, ensuring activities are performed according to regulatory strategies and assisting with regulatory questions.     Qualification & Experience Master of Pharmacy (M. Pharm): Minimum of 12 years of pharmaceutical industry experience; minimum of 8 years of regulatory experience; clinical experience preferred. Excellent organizational, interpersonal, verbal, and?written communication skills, strong grammar, and?proofreading/editing skills, and MS Office skills are required. Track record of successfully working with cross-functional teams, including external partners  

Responsibilities Plan and design market research analyses based on a sound understanding of the research tools, techniques, datasets, and resources available and their use at various stages of the ‘product life-cycle’  Have the functional knowledge of and experience using statistical methodologies and analytical models  Provide effective guidance to planning of studies, including research material design  Input and guide report structure to illustrate complex analysis in user friendly and easy to digest way  Provide alternative proposals/different approaches and suggestions for optimization of approach and alignments with other studies performed or planned. Implement and complete studies on local, regional & global level  Assist line manager/ MR LT with delivery of financial targets for MR. Deeply understand customer needs and promote MR service development  Meet important metrics tied to performance to contribute to overall financial and department success      Qualifications & Experience 7-8 years work experience in market research / specialist agencies. Significant experience of driving small and large multi-country MR studies.  Experience in working across regions and within a commercial, market research team, responsible for managing projects end to end  Preferred: Knowledge of the disease areas within the Pharma sector, with strong presentation skills  University degree BA/BS/MA degree in business, statistics/mathematics, medicine, sciences, health economics, sociology, psychology.  Fluency in English, superior written composition skills  Ability to communicate optimally and to have a persuasive and credible presentation style  Strong intuition for business and solution-orientation approach. Experience in remote relationships (on-shore/off-shore capability delivery). 

Responsibilities Hands on experience to manage Business Glossary, Technical Metadata, Data Lineage, Data Quality, Data Profiling, Master & Reference Data using tools such as Collibra, Informatica, EBX is a Mandatory skill to be successful in this role. Extensive knowledge of Developing Data Strategy, Process Improvement, Data Management Problem Identification & Validation. Associate director works with senior customers in business, operations & technology to define data management roadmap. Also accountable to chair data council and working groups within the assigned domains. Experience of working on data standards such as CDISC, IDMP, IMDRF, MEDDRA, WHODRUG will be added advantage. Ability to challenge status quo, asking relevant data management questions, effectively summarizing current state, bringing insights, and recommending the directions for target state, developing strong working relationship and influencing variety of customer groups is a must have skill. Experience in performing data maturity assessment by using industry agnostic frameworks such as DCAM. This role reports to Enterprise Data Owner for Drug Development domain. Should have experience in program management including project financials. Demonstrated experience in developing data policy, data management framework, guidelines and standards. Knowledge of data management tools such as Collibra, EBX Tibco, Informatica, or any data quality, data governance and master data tools.     Qualifications & Experience 15+ years of overall experience. 8+ relevant years in data management. 5+ in Pharma / Life science. Research & Development domain is preferable. Enterprise Data Management, Data Management Strategy, Data Quality Management, Master & Reference Data Management, Metadata Management, Data Flow / Lineage, Data Governance, Data Stewardship, Customer Management, Program Management, Data Proposal & business value, Project Financials, Communication, Data Literacy, Data Councils, Data maturity Assessment, DAMA, DCAM Hands on experience with data governance, data quality, and master / reference data tools such as Collibra, Informatica Data Quality, Tibco EBX and SQL

Responsibilities Develop, review, and evaluate clinical guidelines and Drug Utilization Reviews, provides consultations, develops programs, prepares articles, and conducts research.   Assess the identity, strength and purity of medications. Review prescriptions to assure accuracy, to ascertain the needed ingredients, and to evaluate their suitability. Provide information and advice regarding drug interactions, side effects, dosage and proper medication storage. Analyze prescribing trends to monitor patient compliance and to prevent excessive usage or harmful interactions. Order and purchase pharmaceutical supplies, medical supplies, and drugs, maintaining stock and storing and handling it properly. Maintain records, such as pharmacy files, patient profiles, charge system files, inventories, control records for radioactive nuclei, and registries of poisons, narcotics, and controlled drugs. Advise customers on the selection of medication brands, medical equipment and health-care supplies. Collaborate with other health care professionals to plan, monitor, review, and evaluate the quality and effectiveness of drugs and drug regimens, providing advice on drug applications and characteristics. Compound and dispense medications as prescribed by doctors and dentists, by calculating, weighing, measuring, and mixing ingredients, or oversee these activities. Offer health promotion and prevention activities, for example, training people to use devices such as blood pressure or diabetes monitors. Prepare sterile solutions and infusions for use in surgical procedures, emergency rooms, or patients' homes. Plan, implement, and maintain procedures for mixing, packaging, and labeling pharmaceuticals, according to policy and legal requirements, to ensure quality, security, and proper disposal.     Qualifications & Experience Able to work accurately and with minimal supervision. Ability to comprehend written instructions given by the Doctors and the other related departmental personnel. Ability to plan & organize ones work schedule effectively. Speaking and listening are essential requirements to understand and carry out the instructions given by the supervisors and other related departmental personnel. Affinity to work in team. Enthusiasm. Open-mindedness.

Responsibilities Verifies and abstracts all the relevant data from the medical records to assign appropriate codes for the following settings: Multispecialty Outpatient Clinics, Urgent Care Centres, Inpatient Hospital Setting Code 12 charts per hour and meeting the standards for quality criteria Needs to constantly track and implement all the updates of AMA guidelines, AHA guidelines, and CMS guidelines Under general supervision, organizes and prioritizes all work to ensure that records are coded and edits are resolved in a timeframe that will assure compliance with regulatory and client guidelines Adherence with confidentiality and maintains security of systems. Compliance with HIPAA policies and procedures for confidentiality of all patient records Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do so     Qualifications & Experience Life Science or Allied Medicine Graduates with certification from AAPC or AHIMA 4 - 7 years in multispecialty Evaluation & Management medical coding Hands-on experience in coding multispecialty Evaluation & Management services such as Internal Medicine, Family Medicine, Urgent Care, Dermatology, Gastroenterology, Cardiology, Otolaryngology, etc. Sound knowledge in Medical Terminology, Human Anatomy & Physiology Proficient in ICD-10-CM, CPT, and HCPCS guidelines

Responsibilities Prepares patients for surgery and addresses their concerns Ensures the operating room is sterile Secures necessary supplies and instruments for surgery Hands over medical supplies to attending surgeons during operations Monitors patients’ physical and emotional well-being throughout the care continuum Observes patient vital signs Informs attending surgeon of issues and anomalies Assessing patients prior to surgery and alleviating their concerns Gathering all supplies needed for the operation Assuming responsibility of keeping the operating room sterilized Assess patients prior to surgery (e.g. NPO status) and alleviate their concerns Gather all supplies needed for the operation Assume responsibility of keeping the operating room sterilized Position and prepare patient on operating table Pass medical instruments or other objects to the surgeon during operation Monitor patient’s vital signs to detect anomalies Evaluate patient in postoperative phases Adhere to safety standards and precautions Assume duties within or out of the sterile field as assigned   Experience 2-10 years