Head, Global Medical Operations

Lawrence Harvey

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Job ID :

8402


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Medical Doctor,Other,phD


Address 1 :

North America,--Virginia,Virginia,


Key Skills :

Head, Global Medical Operations


Salary :

Negotiable


Date Posted :

18 Aug, 2017



Company Name :

Lawrence Harvey


Location1 :

Virginia




Job Category :

Pharma Business Development Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

upto 15%





Description

ESSENTIAL FUNCTIONS:
The responsibilities of this job include, but are not limited to, the following:

Publications

* Responsible for the development of publication strategies, tactics, delivery, and budget(s) to support overall medical and business objectives. Tracks execution of plans and budgets, informing key stakeholders of challenges and opportunities.

* Achieves full understanding of development programs, regulatory and medical strategies, and key scientific and communication objectives for the therapeutic area by interacting directly with internal stakeholders (eg, Medical Affairs, HEOR, etc), in order to develop strategically impactful scientific publications plan.

* Chairs the Publications Management Committee to ensure rigorous review/approval and scientific excellence of publications plan and presentations

* Attends conferences, symposia or other meetings as necessary or as assigned and acts as liaison between Communications, US and Global Medical Affairs, Global Publications, and external content contributors

* Manages publication programs with the external vendor model and assesses performance against global publication and medical strategies. Manages assigned vendor(s) and ensures good publication practices are followed and implemented.

* Develops and maintains relationships with external authors through scientific discourse and active participation in publication development

Clinical Research

Interacts with colleagues in Reginal Medical Affairs, R&D, and Strategy to conducts a comprehensive, yearly gap analysis which will inform the development and prioritization of the Phase IIIb/IV, Investigator Initiated Studies (IIS), and Indivior Research Awards (IRA) strategies across the lifecycle of assigned product(s)

Phase IIIb/IV studies

* Supports the management, design and execution of clinical studies (eg, phase IIIb/IV, disease registries, epidemiological studies, outcomes surveys, etc.), collaborating closely with Regional Medical Affairs, Therapeutic Area Clinical Development head and Global Clinical Operations

IIS

* Leads and supervises IIS program, including initial and committee reviews, approval, and execution of IIS protocols

* Chairs IIS Committee; Manages and generates appropriate responses to applicants

* Supervises coordination and processes for approved IIS study contracts; tracks and provides updates on approved IIS

* Prescriber Concern Report (PCR) Process Supervises the Medical Affairs Coordinator who focuses on the Prescriber Concern Report (PCR) process

* Evaluates and determines actions to be taken in response to PCRs forwarded by Medical Scientific & Treatment Advisors

* Chairs the PCR Review Committee, oversees the PCR process and executes decisions

* Manages and generates appropriate responses and communications with prescribers identified for action through the PCR process


Company Name:

Lawrence Harvey


Headquarters:

150 Leadenhall Street,London


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC3V4TE


Website:

www.lawrenceharvey.com


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

0203 327 3072


Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

For more information,visit www.lawrenceharvey.com.

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