April 13th, 2013, 12:44 PM
Post Count Number #1
www.biocon.com Biocon Bangalore : Medical Lead
Biocon, Bangalore
Company Web Page : http://www.biocon.com
Requirement : Medical Lead - HC/JC/2351/2013
Job Category : R & D
Location : Bengaluru
Experience : 0.00 to 0.00 years
Education : MBBS, Ph.D
Skills :
** Minimum of 4 years of industry experience in designing clinical trials with proven experience of successful leadership in NCE/biosimilar drug development.
** Thorough knowledge of Good Clinical Practice, statistics, regulatory processes, and global clinical development process.
** Advanced knowledge of the assigned Therapy Area is preferable
Industry Type : Biopharmaceuticals
Job Description :
** Define Target Product Profile and draft Clinical Development Plan for the assigned projects, update the same and keep updated based on inputs from various line functions.
** Medical monitoring of the trials, point contact for all safety and medical questions for assigned trial.
** Will develop and sign off on : Protocols, IB, IND/CTA clinical sections, briefing books, CSR, clinical dossier and publications
** Maintain effective relationships with key investigators to ensure high scientific quality and relevance of trial design and endpoints.
** Will have direct oversight on operations team. Accountable for the trial metrics- FPFV, LPLV, DBL and CSR timelines, the medical expert will be the driver of the team performance to achieve milestones for the project.
** Lead investigator meetings, KOL meetings and advisory boards
Requirement : Manager - BD & Program Management - HC/JC/2471/2013
Job Category : NA
Location : Bangalore
Experience :6.00 to 10.00 years
Education : BSC(HONS), M.B.A
Skills :
Exhibits logical and rational decision making under stress Sound knowledge of MS Projects
1. Go getter attitude and good planning, coordination and Inter personal skills
2. Good oral and written communication
3. Awareness about program management principles and practices
4. Experience in leading a team and man management competencies
Industry Type : Pharma/Biotech/Clinical Research
Posted On : 09-Mar-2013
Job Description :
** Sales & Strategy- SAARC region, except India
** Cross-functional matrix leadership across International RA, QA, Manufacturing, Packaging to enable dossier preparedness for the region
** Identify in-house products and fit to SAARC markets based on market size, commercial attractiveness and dossier readiness
** For identified products, drive product registration and commercialization efforts
** Prospect and drive selection of channel partners in SAARC for identified products
** Lead KOL engagement activities, manage and facilitate interaction between India PMT, MA & SAARC KOLs
** Drive CMEs, participation in Congresses and scientific symposia to establish the product
** Devise commercialization model and pricing strategy, keeping commercial opportunity and regulatory landscape in view
** Own and drive the “market-entry” strategy, in terms of a sales & marketing footprint in the SAARC markets, in a sequential manner.
** Work closely with exports sales team from Proforma Invoice through order execution process
** Alliance management w/ Licensee and/or business channels
To initiate, Plan, Monitor and perform Closure (on successful completion) and drive the project(s) to successful completion :
** Project Initiation - Preparation, Sign off and roll out of project charters, Project Kick off meeting with all stakeholder
** Project Planning - Preparation, Sign off and Roll out of project plan (prepared on MS projects), Risk identification and Mitigation plan
** Project Monitoring - Baselining of project plan, daily tracking and updation of gantts,Periodic review with functional team to update status, prepare project updates, prepare MOMs and followup on action items
** Project Closure - Prepare project closure report comparing plan vs actual
** Process Improvement and Standardization - Roll out of Project management process in small molecules, Gantt Template for various models (In-house / LL / P2P), Template for various updates (external and internal)
** Prospect and drive strategic alliances with vendors for product development, for identified drug product candidates
Apply through the website ...
Contact Us :
20th KM, Hosur Road,
Electronics City,
Bangalore, India - 560 100