Head, Regulatory Affairs Advertising and Promotion

Lawrence Harvey

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Job ID :

11496


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc,Medical Doctor,phD


Address 1 :

North America,United States of America,Washington,


Key Skills :

Head, Regulatory Affairs Advertising and Promotion


Salary :

Negotiable


Date Posted :

16 May, 2018



Company Name :

Lawrence Harvey


Location1 :

Washington




Job Category :

Regulatory Affairs 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:

* Develop and implement innovative regulatory strategies to ensure the company's ability to optimize the commercial success of clients products through advertising and promotion within FDA- and corporate-defined boundaries.

* Avoid regulatory, legal and financial risks associated with advertising and promotion of clients prescription drug and medical device products by providing sound, well-reasoned regulatory advice to senior management.

* Serve as the Chair of the Copy Clearance Governance Committee (CCGC) to review and approval North America MRC and PRC policies and procedures and the resolution of escalated review items.

* Establish policies and SOPs that ensure the creation, review and approval of medical / scientific and promotional materials that comply with the company's code of conduct and relevant external national / regional advertising & promotional regulations or codes of practice (e.g. ABPI Code of Practice, FDA regulations, TGA Therapeutic Goods Advertising Code) and are consistent with clients guiding principles

* As Chair of the CCGC, provide periodic updates to the Executive Committee on the performance of MRC and PRC, including resourcing and forecasting to ensure efficient and quality reviews

* Work closely with other functional areas of medical, legal and compliance in the review and approval of Business Needs Assessments related to external commercial and medical activities associated with KOL meetings, symposiums and market research.

* Contribute to the creation and implementation of strategies and practices that ensure the creation of quality promotional material * Influential regulatory representative to the Global Regulatory Affairs leadership team.

* Maintain US Regulatory budget by working with Finance to ensure that monetary control over spending is maintained on a monthly/annual basis

* Establish and nurture a collaborative and respected working relationship with the head of the Office of Prescription Drug Promotion at FDA that ensures expeditious consultation on matters that have the potential to affect promotion of client's products.

* Ensure value-based processes are in place to prevent, detect and correct violation of clients MRC / PRC review and approval procedures and regulatory requirements.

* Ensure new information related to advertising and promotion of prescription drug products is analyzed and the impact communicated to the organization

* Ensure sound regulatory practices are fully integrated into training of all individuals involved in the creation, review and approval of promotional material for Clients.

* Attract, develop and retain a team of key regulatory professionals, recognized for their customer focus and regulatory and scientific acumen

* Provide leadership and direction that ensures staff will meet expected delivery targets

* Assist with other assignments or projects as assigned by the SVP, Global Regulatory Affairs





MINIMUM QUALIFICATIONS:

Education: Bachelor's degree required, Master's Degree, PharmD or PhD in a biomedical science preferred

Experience:

* A minimum of 15 years of pharmaceutical industry experience required with 8 years in a Regulatory Affairs leadership role.

* Demonstrated track record of leading promotional copy review and approval team and working within a highly matrix organization.

* Demonstrate track record of successful interactions with OPDP staff and management



Travel: <15%

COMPETENCIES/CONDUCT:

In addition to the minimum qualifications, the employee will demonstrate:

* Strategic thinking with a bias for strong results-orientation with a demonstrable track record of success

* Excellent interpersonal skills/leadership presence and ability to engage and influence internal and external stakeholders.

* Demonstrate high levels of energy and drive; ability to set and deliver challenging targets.

* Confidence to challenge the status quo, to speak up and to manage and deliver change.

* Self-motivated and highly flexible - Ability to multi-task in a fast-paced atmosphere with multiple/changing priorities

* Experience leading and developing/mentoring junior staff

* Excellent written and verbal communication skills



BENEFITS:

This client is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do.

* 3 weeks' vacation plus floating holidays and sick leave

* 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay

* U.S. Employee Stock Purchase Plan- 15% Discount

* Comprehensive Medical, Dental, Vision, Life and Disability coverage

* Health and Dependent Care Flex Spending options

* Adoption assistance

* Tuition reimbursement

* Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage

* Gyms, fitness facilities and cell phone discounts

* Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.


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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