**Main responsibilities:** _Write and/or edit under guidance high-quality clinical and safety documents for submission to regulatory authorities to support marketing authorization applications, renewals, and maintenance activities including complex Clinical Study Reports (CSR), complex CTD submission documents (clinical overview_ _[_ _CO_ _]_ _, summary of clinical efficacy_ _[_ _SCE_ _]_ _, clinical safety_ _[_ _SCS_ _]_ _, clinical pharmacology_ _[_ _SCP_ _]_ _, and biopharmaceutics_ _[_ _SBP_ _]_ _), medical section of Periodic Benefit-Risk Evaluation Report_ _(_ _PBRER_ _)_ _,_ _medical sections of_ _addendum to clinical overview_ _(_ _ACO_ _)_ _, Risk Management Plans (RMP),_ _Product and Disease_ _ID Cards, clinical evaluation report, Briefing packages, responses to Health Authorities Queries, and immunogenicity reports_ _, product alerts and trial transparency documents with added knowledge and expertise._ _Delivery of high-quality medical documents on time and in compliance with internal and external standards_ _and guidelines_ _._ _Works independently on documents_ _acting as an SME_ _on clinical deliverables_ _,_ _buddy_ _or mentor to the medical_ _and senior medical_ _writers_ _, efficiently peer reviews_ _providing_ _Scientific inputs_ _._ _Essential Job duties and responsibilities:_ 1) _Leading complex submissions, contributing to key messaging meetings,_ _providing_ _expert content guidance for medical sections of CTD, and delivery of high-quality medical documents in time and in compliance with internal standards and external guidelines_ _._ _2)_ _Participate in_ _the_ _planning of analysis and data presentation to be used as an ad-hoc member of the Clinical Trial Team (CTT),_ _a_ _core member of the Clinical Submission Teams (CST)_ _,_ _and_ _an_ _extended member of the Global Clinical teams (GCT) and Safety management team (SMT)_ _. 3)_ _Develops and_ _maintains_ _TA_ _expertise_ _and_ _provides_ _document-related advocacy to other line functions_ _. 4)_ _Reviews content created by peer writers and act as a coach, mentor,_ _and_ _trainer for_ _the_ _development of writers for the new document type_ _. 5)_ _Work with minimal supervision and support development of medical regulatory writers_ _. 6)_ _Agile and knowledgeable to be able to work across therapeutic areas._ _Collaborates effectively with Scientific communication global or local teams, Medical regulatory writing global or local teams, Pharmacovigilance teams, CTT, CST, GCT, and SMT_ _._ + _People:_ _1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the_ _allocated_ _Global business unit and product – with an end_ _objective_ _to develop medical regulatory content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly_ _assist_ _other medical regulatory writers in developing knowledge and sharing_ _expertise_ + _Performance: 1)_ _Provide deliverables (CSR, CO, SCE, SCS, SCP, SBP, PBRER, ACO, RMP, ID Cards, clinical evaluation report, Briefing packages, HAQs, Immunogenicity reports) as per agreed timelines and quality_ _2) Fair understanding of Product Alerts, and trial_ _transparency documents with the agility to learn and contribute_ _to_ _situations of demands_ + _Process: 1) Acts as an expert in the field of medical regulatory writing and_ _maintains_ _the regulatory requirement for countries supported. 2) Assist the assigned medical team in conducting comprehensive medical regulatory writing-needs analysis_ _. 3)_ _Implement relevant elements of the medical regulatory plan and associated activities for the year_ _identified_ _for the region_ _. 4)_ _Work with_ _selected vendors_ _within the region to deliver the required deliverables_ _per the defined process_ _. 5)_ _Design an overall plan of action basis end-customers feedback & improve course content and delivery_ _6) Substantial understanding of Product Alert Process and Trial Transparency documents_ _with the ability to quickly_ _develop_ _expertise_ _and contribute swiftly if the situation demands_ + _Stakeholders: 1)_ _Work closely with medical teams in regions/areas to_ _identify_ _medical writing needs and_ _assist_ _in developing assigned deliverables_ _. 2)_ _Liaise with th_ _e Medical department to prepare relevant & customized deliverables_ _. 3)_ _Collaborate with CTT, CST, GCT and SMT_ _._ _4)_ _Proactively_ _l_ _iaise with the Clinical/Medical/Pharmacovigilance/Biostats/Regulatory/Legal/Regulatory/Corporate Affairs departments to prepare relevant & customized deliverables._ _About you_ + **Experience** : _≥8 years of experience in regulatory writing for the pharmaceuticals/healthcare industry_ + **Soft skills** : _Stakeholder management; communication skills; and ability to work independently and within a team environment_ _, leading project teams_ + **Technical skills** : _As applicable (including but not limited to therapeutic area/domain knowledge exposure; publication submission; and/or project management_ _; Expert knowledge of and_ _demonstrated_ _accomplishment in global registration of drugs_ _)_ + **Education** : _Advanced degree in life sciences/ pharmacy/ similar discipline (_ _PhD_ _, Masters, or_ _bachelor’s in science_ _, D Pharm_ _a_ _, Pharm D_ _) or medical degree (MBBS, BDS, BAMS, BHMS, MD)_ + **Languages** : _Excellent knowledge of_ _the_ _English language (_ _to read, write and speak_ _)_ **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. 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