US Lead, Executive Medical Director, Medical Affairs

Lawrence Harvey


Job ID :

12736


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Medical Doctor


Address 1 :

North America,--New Jersey,New Jersey,


Key Skills :

Executive Medical Director, Medical Affairs - Sleep Disorders


Salary :

Negotiable


Date Posted :

27 Aug, 2018



Company Name :

Lawrence Harvey


Location1 :

New Jersey




Job Category :

Executive Pharmaceutical Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

upto 15%





Description

Responsibilities include but are not limited to:

1. Medical Affairs Strategic Plans: The incumbent will work with key stakeholders, management, and functional area leads to develop strategic and aligned US Medical Affairs Plans for the therapeutic area and will be expected to communicate and represent these plans to upper management/senior leadership. This includes responsibility for continuously updating plans and informing stakeholders of progress.

2. Phase IV clinical studies: Direct and design strategies, planning and implementation of Phase IV clinical development programs for assigned products. Provide medical oversight for protocol development, interpretation of trial results, final study report conclusions and publications. Serve as study director for trials. Provide critical medical input into the lifecycle management strategies in responsible therapeutic areas.

3. Medical/Scientific subject matter expert: Serve as medical leader and subject matter expert providing direction for assigned products including (but not limited to) CRC, scientific communications, publication planning/review, advisory boards, health outcomes plans, MSL activities, speaker programs, investigator-initiated research and CME grant reviews or other internal key business processes. Other responsibilities include approval of the medical and scientific content of Regulatory, Safety, Scientific Affairs, Medical Affairs and Commercial outputs for assigned therapeutic areas.

4. External leadership: Provide leadership and strategic direction to stakeholders in interactions and communications with external customers, thought leaders, strategic alliances, key organizations, and institutions. Maintain external orientation by participating actively in external events and activities.



Must Know:

*Therapeutic Area Expertise including standards of care, current medical options for diagnosis and treatment of relevant conditions based upon franchise products
*Understanding Medical Affairs activities preferred
*Understanding of Marketing concepts/strategies preferred
*Knowledge of the pharmaceutical marketplace
*FDA regulations/ICH guidelines regarding conduct of clinical studies in relevant therapeutic area
* Knowledge of regulatory guidance regarding marketing/sales promotional materials
* Strong overall written and verbal communication skills
* Must have requisite skills to function in a complex and dynamic environment, including flexibility and ability to negotiate.
* ICMJE guidance/general publication practices
* Current ACCME guidelines
* Sound computer skills including Microsoft Word, and PowerPoint
* Familiarity with statistical methodology
* PhRMA Code
* Travel 35%


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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