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Medical Manager

Edison, New Jersey, United States
January 19, 2017

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***, *** **** ****, ******, NJ 08817 - +1 848 *** ****

A Highly Dedicated Medical Professional with a Strong Background in Pharmaceutical Science SUMMARY OF QUALIFICATIONS

Excellent analytical skills

Consistently complete all projects on time

Work well independently and in a team environment

Actively participate in group meetings

Outstanding interpersonal and communication skills

Able to work effectively with people in a matrix organization at all levels

Organized, detail oriented

Dependable, loyal, diligent professional with a solid work ethic PROFESSIONAL EXPERIENCE

iPharma 2016 - Present

Associate – Medical Affairs

New Brunswick, NJ

Driving the development and execution of the Medical Affairs strategic plans in alignment with Clinical, Regulatory, Commercial and Corporate Communications groups including: 1. Disease/Mechanism of action education plan

2. KOL/Advisory management plan

3. Medical communication, publication plan

4. Investigator-Sponsored Trial (IST)/ Phase 4 development plan 5. Field Medical Liaison Plan

Ensuring alignment of medical affairs strategies with the overall Medical and Commercial goals and objectives of the organization

Providing medical input for scientific and promotional documents, and support of business development activities

Working with Medical Development on secondary analyses of primary data and lead the development and execution of clinical registry studies and observational research to address information gaps as appropriate

Driving major scientific congress planning; strategically target relevant meetings and assure data for products appropriately positioned for presentation in alignment with our corporate strategic objectives

Working cross functionally to collaboratively identify and qualify centers of excellence in alignment with the MSL, Nurse Specialist, Medical Development and Commercial groups and the planned launch plan timeline

Serving as key external spokesperson with KOLs, payers, and professional societies

Contributing to the development and maintenance of a competitive intelligence database in partnership with the MSL, Nurse Specialist and Medical teams

Developing and maintain knowledge of global pharmaceutical regulations, guidelines, codes of practices and company policies related to all medical activities

Works closely with divisional leadership and key functional area stakeholders to drive execution of strategy and tactics to achieve business objectives

Astron Pharma 2013 – 2016

Clinical Research & Regulatory Affairs Manager

Riyadh, KSA

Demonstrate study and clinical investigative site management according to Good Clinical Practices, local regulations

Create and provide input into study management requirements and tools, monitoring tools and manuals and training tools

Maintain thorough understanding of current monitoring practices and applicable regulatory requirements and guidelines

Perform study oversight and study site visits to ensure regulatory and study requirements are being fulfilled

Review study records including case report forms, consent forms, and other materials, and is versed in remote monitoring approaches

Develop and maintain collaborative relationships with investigational sites study teams, CRO teams, and vendor teams

Participate in company, departmental and project team meetings

Actively contribute to the development and implementation of regulatory strategy for assigned projects

Translate regulatory requirements into practical workable submission plans

Monitor company progress towards fulfillment of regulatory commitments

Review and communicate emerging regulatory requirements to ensure compliance

Author and review SOPs; Act as a liaison between Regulatory Affairs and other functional areas; represent Regulatory Affairs in cross functional meetings

Interface with external regulatory groups and regulatory agencies

Contribute to cross-functional Health Authority Response Teams for assigned development projects and / or marketed products and prepare regulatory responses, as appropriate

Astron Pharma 2009 - 2013

Senior Medical Science Liaison (ONCOLOGY)

Riyadh, KSA

Expanded on and leverages thought leader relationships by aligning thought leader expertise with company needs

Successfully connected thought leaders internally to serve as advisors, investigators, expert guest speakers, or business development partners

Executes on MSL goals and objectives and Medical Affairs product plans

Applies advanced field-based medical and scientific experience, subject matter knowledge, and skills in supporting company medical strategy

Regularly collected and interpreted medical insights and feedback gathered from scientific exchange with thought leaders and communicates relevant information to internal stakeholders in order to define, update, and support medical strategies

Identified and facilitated investigator initiated trials (IIT) aligned with company medical strategies

Upon request of Clinical Affairs, assists in clinical trial support by identifying, evaluating, screening, and providing scientific support to qualified research sites

Addressed unsolicited requests for medical information from health care professionals

Actively participated in executing company strategy at scientific meetings by identifying relevant sessions, coordinating MSL meeting/booth coverage, and proactively facilitating thought leader interactions with company stakeholders

Provided ongoing scientific and medical training within the MSL team and to internal partners

Provided ongoing scientific and medical training within the MSL team and to internal partners

Provided clinical presentations and medical information to managed markets and government accounts upon request

Identified and brought forth team needs to MSL leadership

Lead, actively participated in and contributes to MSL or cross-functional projects and initiatives

Served as a new hire mentor, field coach, and resource for other members of the MSL team

Completed all required training, documentation, expense reporting, and other administrative responsibilities

Ensured compliance with all FDA and company requirements ROCHE 2008 - 2009

Medical Science Liaison

Riyadh, KSA

Promoted two levels up in the management as a Medical Science Liaison for oncology

Provided fair balanced scientific information to national and regional KOLs

Presented published clinical data at journal clubs and faculty meetings of leading hospitals

Actively participated in the resolution of complex disease management issues related to oncology

Ensured that regulatory approvals remain in compliance with their authorizations and with current regulatory requirements

Worked on Development strategy with project teams to develop regulatory strategy for assigned projects

Identified, established and maintained collaborative relationships with key physicians, institutions, groups and consortia strategic to the effective use of company product

Worked with the appropriate internal and external departments to ensure required education and training are provided

Maintained clinical expertise through aggressive education, including attendance at relevant conferences, scientific workshops and review of key journals

Took advantage of opportunities to mentor other MSL team members, and participates in cross-functional Medical Affairs teams

Assisted the organization toward providing response to unsolicited requests for information with his/her direct collaboration with Medical Information Services personnel

Substantively contributed to scientific publication planning, slide-deck development, training initiatives and the development of a Medical Strategy Plan

Completed accurate and timely administrative reports, project plans, and required documentation requests ROCHE 2005 - 2008

Senior Product Manager

Riyadh - KSA

Was responsible for Oncological Product

Tracked and analyzed business environment and market trends

Conducted brand Strategy Planning, Implementation

Brand Wise activity planning to boost brand performance and monitoring of some special regions by close interaction through Zonal Heads

Participated in CME and resource allocation and doctor interactions

Brand Extension validity, planning and budgeting

Actively launched for new Product as per company guidelines

Performed new product surveys

Trained healthcare professionals on the use of newly launched products

Built a strong team of leaders to drive unit

Explored and developed new markets to build the sales

Achieved annual business target

ROCHE 2003 – 2005

Regulatory Affairs Associate

Riyadh - KSA

Compilation of adequate registration dossiers in order to obtain product registration according to the criteria as issued by the respective authority. Working according to planning and schedules

Resolved queries received from various Drug Regulatory Authorities by working with different departments like R& D, Production QC, QA, Packaging and Imports & Exports

Active Follow up with Product Registration Cell department in plants for their comments in the Technical Agreement followed by Finalization of TA

Prepared, Reviewed & Finalized of Technical Agreements (TAs) in co-ordination with Plants and various European Clients

Timely follow up of technical queries of regulatory authority

Effective communication with supplier/manufacturer and with local agents GOVERNMENT HOSPITAL 2000 - 2003

Medical Officer




Doctor of Medicine ( MD )


MBA in Health Care Admin. 2000 - 2002


MS Windows, MS Word, MS Excel, MS PowerPoint

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