Require Drug Safety Executive at Roche @ APply Now

Post : Executive - Drug Safety

Job Description : 
Ensures that collection, reporting and handling of safety information associated with Roche products is performed according to global Roche and local regulatory requirements.
• Maintains oversight of LSU activities and management of safety information, safety risk management and all other pharmacovigilance (PV) activities, ensuring PV medical compliance (Roche policies and procedures, global and local regulatory requirements) and inspection readiness for country(ies) within their area of responsibility.
• To review and access all the source documents for reporting adverse events from all spontaneous and solicited sources and track into respective PV tools/local trackers
•  To ensure effective communication with internal/external stake holders in context to any discrepancy, follow-ups regarding safety information.
• To review, access and submit the individual case safety reports to Regulatory Authority in timely manner and track the submission in safety database, tracking tool and systems
• Collaborate with Regulatory team and supply chain and logistic team to ensure timely submission of aggregate reports to Regulatory authority based on the approval of the product and track the submission records in local tracker, systems and tools
• To collaborate with legal, supply chain and logistics to assess requirement of PV agreement execution.
• To ensure the process for patient centric distribution network in collaboration with DST team
• To Ensure PV oversight for direct markets 
• To maintain oversight of the out of hours coverage and testing mechanism of reporting , records management and archiving, SOP and process and  adverse event training completion activities for all Roche Users

Functional & Behavioral Competencies
• Knowledge of Pharmacovigilance information
• Knowledge of PV relevant regulations (ICH, EMEA, US FDA and local regulatory Authority)
• Knowledge of Medical Terminology – Verbal and written
• Team Work and Collaboration
• Inspiring and Influencing
• Communication
• Strategic planning

Additional Information
Location : Mumbai, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Drug Safety
End Date : 20th May, 2019

Require Assistant Manager in Strategic Sourcing at Roche @ Apply Now

Post : Assistant Manager - Strategic Sourcing

Job Description:
• Drive all procurement activities along a comprehensive and robust framework covering the end-to-end processing
• Partner with the business to ensure optimal sourcing and adequate control over all critical procurement steps
• Partner with the regional and global procurement teams and deliver results in line with their requirements
• Ensure highest levels of integrity and adherence to the Code of Conduct
• Continuous improvement
• Drive continuous improvement in all Procurement-related areas like strategies, policies, processes, templates, forms and exploring digital solutions

Functional Competencies:
• Procurement standards, processes and systems
• Technical and business expertise
• Achieving results

Behavioral Competencies:
• Exhibition of RLCs and RCVs
• Exhibition of Quantum self
• Strong communication skills
• Highest levels of integrity
• Strong teamwork and collaboration skills

Additional Information
Location : Mumbai, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Strategic Sourcing
End Date : 20th May, 2019

Require Executive Regulatory Affairs at Roche @ Click Here for more details

Post : Executive Regulatory Affairs

Job Description:
Dossier preparation, ensuring timely submission of dossiers, respond to queries from regulatory authorities and keeping one’s self updated with changes to the regulatory environment with the objective of ensuring that the organization obtains approvals and licenses in a timely manner.

• Regulatory Plan Creation:  Collaborate with global teams during early stages of product development; Understand  regulatory requirements in the country from development and data perspective; Understand timelines of availability of various documents for filing the application and prepare the dossiers / application for quality submission on time
• Dossier preparation, review and submission: Request documents from global and local teams for filing the application well in advance; Co-ordinate with team members for accurate collation of the documents for filing the application; Proactively, work with the liaison person to track the submission; Understand likely queries and keep documents ready in advance to either share the same to prevent the query or to have short lead time in submitting the response
• Lifecycle Management: Prepare and maintain the trackers for market authorization, registration certificates, import licenses, post marketing commitment, package insert submission so as to facilitate timely submission of the applications as well as for maintaining regulatory compliance at high level; Plan renewal filing well in advance to avoid any delays in submission due to non-availability of the documents; Evaluate and submit variations in a timely manner
• Regulatory Environment updates: Keep a track on the development activities of competitors and communicate to the team members on real time basis.

Functional Competencies:
• Roche high performance competencies Decision making
• Influencing /persuasion skills Driving collaboration and team work Technical knowledge
• Organization and planning skills Negotiating skills Communication Skills Presentation Skills
• Proven ability to interact well in a multifunctional team setting
• Accuracy and attention to detail

Behavioral Competencies:
• Strategic Agility Achieving results
• Team work and Collaboration Inspiring and Influencing Interpersonal Skills Adaptability
• Patient centricity in decision making
• Feedback and coaching

Additional Information
Location : Mumbai, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th March, 2019

Require Assistant Manager in Clinical Operations at Roche @ Apply Now

Post : Assistant Manager - Clinical Operations

Job Description:
• Highlights deviations and risks in plans to relevant parties, develops and implements mitigation strategies as required.
• Leads local study teams, represents Country /Region Clinical Operations at the global SMT, and provides Global Teams with feedback from an Affiliate perspective (Global).
• Plans and executes country study goals and commitments, and ensures compliance to relevant processes.
• Coaches and provides support to responsible study team members.
• Provides study oversight, leadership and support to Contract Research Organisation (CRO) staff to ensure overall delivery at the country and site level, and interfaces with CRO Management regarding feedback on CRO staff performance as required.
• Oversees study feasibility, site monitoring performance, preparation of Risk Based Monitoring plans, and ensures eTMF completeness and oversight of all relevant compliance activities for allocated studies.
• Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and completion of Corrective and Preventative Actions for allocated studies.
• Develops and maintains optimal site relationships with key investigator sites, alliance partners and/or collaborative group for current and future Roche studies.
• Participates in overall Therapeutic Area support together with the therapeutic leads and country experts (e.g. landscaping activities, investigator/site development activities or affiliate cross functional teams, etc.), as required.
• Performs/coordinates for Health Authority presentation for the study/ protocol amendments.
• For Local Studies, the CSM acts as study leader and, in addition to the above, provides the leadership and clinical operational  expertise for the local study team.

Functional Competencies:
• Decision Making
• Planning and Organizing (Achieving Results/ Strategic Agility)
• Communication
• Customer Orientation (Technical & Business Expertise)- places a high priority on the internal or external customer's perspective when making decisions and taking action; implements service practices that meet the customer's and own organization's needs.
• Coaching (Feedback and Coaching)
• Work Standards- sets high standards of performance for self and others; assumes responsibility and accountability for successfully completing assignments or tasks; self-imposes standards of excellence rather than having standards imposed.
• Innovation
• Technical/Professional Knowledge and Skills

Behavioral Competencies:
• Patient centricity in decision making
• Building Partnerships (Teamwork and Collaboration) - develops and leverages relationships within and across work groups to achieve results.
• Inspiring and Influencing
• Valuing Differences - works effectively with individuals of diverse cultures, interpersonal styles, abilities, motivations, or backgrounds; seeks out and uses unique abilities, insights, and ideas from diverse individuals.

Additional Information
Location : Maharashtra, Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Clinical Operations
End Date : 30th March, 2019

Require Management Trainee at Roche @ Apply Now

Post : Management Trainee

Job Description:
• Building delivering on 3 commitments towards patient centricity and by establishing value of Roche Innovations
• Calls on oncologists and other medical employees to provide on-label pharmaceutical product information for the treatment of cancer in order to capitalize on selling opportunities and/or to influence physician prescribing practices.
• Responsible for the sale of the company’s oncology products within an assigned territory or geographic region.
• Complies with applicable laws in providing oncologists and other medical employees with medical information and literature.
• Provides expertise and customer service to accounts. May provide expertise to oncologists, physicians and other medical/therapeutic clients.
• May gather data on marketing trends, competitive products and pricing. Builds relationships with key thought leaders to influence the acceptance and use of company’s products.
• Typically requires a university degree in a scientific or related field and/or equivalent related experience. Individuals that call on non-specialty physicians, match to S851-S855 - Sales Account Manager - Bio/Pharma Non-Specialty.
• Individuals matched to this job should select Channel 1 - Direct/End User. Use channel-specific Field Sales Management job codes to match the managers of these incumbents (e.g., Field Sales Management - S3X3 - S3X6)

Behavioral Competencies :
• Exhibition of RLCs and RCVs
• Exhibition of Quantum self
• Patient centricity in decision making
• Collaboration Inspiring and Influencing

Additional Information
Location : India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Sales & Marketing
End Date : 21st February, 2019

Apply as Assistant Manager at Roche @ Click Here for more details

Post : Assistant Manager - Quality (GCP & PV)

Job Description:
• To lead the QMS initiative for the Indian affiliate in managing compliance, training, audit/ inspection readiness for medical (GCP & PV), MAP teams & aligning QMS at the Indian affiliate with the global best practices of Roche.
• Monitor Regulations, processes/ procedural documents, Compliance Metrics, Training, systems, tools
• Monitor, prepare & coordinate for Audits/ Inspections & post conduct actionable (for Affiliate and Direct Markets)
• Report changes to ensure processes updated/ aligned where required
• Report Deviations to processes and relevant actionable to prevent
• Report product / data quality issues & Monitoring & evaluation of process/ program effectiveness
• Risk Assessment, Mitigation plans
• Build compliance, implementing learning from other affiliates
• Driving collaboration through establishment of a strong connect with Internal stakeholders to drive collaboration

Functional Competencies
• Knowledge of quality management systems
• Knowledge of Roche (GCP- PV) processes, procedural documents and tools
• Knowledge of GCP&PV
• Knowledge of Clinical Project Management
• Knowledge of Health Authority Requirements

Behavioural Competencies
• Collaboration / fostering teamwork, establishing focus
• Exhibition of Roche Leadership Competencies and Roche Core Values
• Provide guidance / implementable solutions via Analytical thinking
• Exhibit Quantum self
• Patient centricity in decision making
• Critical & Detailed Evaluation
• Unbiased & accurate reporting
• Learn & implement Ethical practices

Additional Information
Location : Maharashtra, Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality (GCP & PV)
End Date : 5th March, 2019

Apply as Manager - Regulatory Affairs at Roche @ Click Here for more details

Post : Manager - Regulatory Affairs

Job Description:
To execute the regulatory strategy by providing guidance to the team for dossier preparation, ensuring timely submission of dossiers, respond to queries from regulatory authorities and keeping one’s self updated with changes to the regulatory environment With the objective of ensuring that the organization obtains approvals and licenses in a timely manner

Regulatory Plan Creation:
Collaborate with global teams during early stages of product development; Share inputs on regulatory requirements in the country from development and data perspective;
Understand timelines of availability of various documents for filing the application and the supply chain of the new product for which regulatory strategy being created; 
Create regulatory strategy for the products assigned and share the same with the manager

Dossier preparation, review and submission:
Request documents from global and local teams for filing the application well in advance; Co-ordinate with team members for accurate collation of the documents for filing the application; Proactively, work with the liaison person to track the submission; Understand likely queries and keep documents ready in advance to either share the same to prevent the query or to have short lead time in submitting the response

Lifecycle Management:
Review and maintain the trackers for registration certificates, import licenses, post marketing commitment, package insert submission so as to facilitate timely submission of the applications as well as for maintaining regulatory compliance at high level; Plan renewal filing well in advance to avoid any delays in submission due to non availability of the documents; Evaluate and submit variations in a timely manner

Regulatory Environment updates:
Keep a track on the development activities of competitors and communicate to the team members on real time basis

People Management:
Set objective goals and evaluate performance of team members; Recommend for promotions; Recommend recognition programs for team; Coach and mentor the team; Provide opportunities to the team to develop their capabilities; Conduct regular team meetings to guide team on departmental issues; Resolve issues faced by team

Functional Competencies
Roche high performance competencies
Decision making
Influencing /persuasion skills
Driving collaboration and team work
Technical knowledge
Organization and planning skills
Negotiating skills
Communication Skills
Presentation Skills
Proven ability to interact well in a multifunctional team setting
Accuracy and attention to detail

Behavioral Competencies
Strategic Agility
Achieving results
Team work and Collaboration
Inspiring and Influencing
Interpersonal Skills
Adaptability
Patient centricity in decision making
Feedback and coaching.

Additional Information
Location : Maharashtra, Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Medical Affairs
End Date : 26th January, 2019

Require Manager in Medical Value at Roche @Apply Now

Post : Manager - Medical Value

Job Description:
Responsible for execution of Medical Strategy through patient centric shared value projects & involvement/ engagement of Top TAEs, Key Strategic Accounts, Academic Bodies & Patient Advocacy groups in line with integrated franchise & Affiliate Strategy 2030.
• Support the therapy lead in execution of Annual Medical Plan for their respective therapy area.
• Investigator Initiates Studies: Manage & Support . Local Data Generation (LDG): Provide support in development of the protocol & Lead the data publication. Global Clinical Trials: Provide medical/scientific input
• Support with medical/scientific data to present in an accurate, fair and balanced manner, consistent with label. Contribute strategic insights for promotional material.
• Ensure the medical/scientific accurate answer, meet local regulations
• Build effective partnerships with Marketing counterparts, Contribute the development of Brand Plans & Strategies
• Contribute to build high value-added medical programs, Gather insights, input and updates on treatments from external experts,.
• Provide timely scientific support to Access teams in preparation of documents to be submitted to institutes / states. Representing Medical Affairs in Policy meetings as an scientific expert
• Support to regulatory team in reviewing and providing suggestions the prescribing information and other regulatory dossier from the medical aspects 
•  This role is accountable and responsible for individual product & supports Medical Value lead to shape & implement Therapeutic area / franchise strategy aligned to Franchise & Affiliate vision. She / he will be scientifically responsible as back up of Medical Value lead for whole franchise

Additional Information
Location : Maharashtra, Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Medical Affairs
End Date : 26th January, 2019

Requirement of Area Sales Manager at Roche Pharmaceuticals

Roche Pharmaceuticals, India, has been disseminating scientific knowledge pertaining to innovative medicines to the medical fraternity. We have products in therapeutic areas such as Oncology, Virology, Nephrology, Transplantation, Anemia... Not translated Arthritis. In recognition of its contributions in Oncology, Roche India has been awarded the ‘Best Oncology Company of the Year,' by Frost & Sullivan at the India Healthcare Excellence Awards for the years 2011, 2012 and 2014.

Post : Area Sales ManagerRoles and Responsibility
(1) Planning  
• Evaluate the market environment & estimate the Demand of Specific Products on a yearly basis
• Prepare  a business  plan  for  the area on a  yearly basis  &  implement  as  per  approval  of  RSM
• Prepare monthly  sales  plan  &  estimate  the  inventory  requirement  at  C & F  level
• Prepare the sales promotion plan through field activation programs, in shop activities etc.
• Review  sales  &  provide  rolling  forecast every  month