PCH Global Medical Affairs Lead - Better Breathing non-MD
Location:
Madison , New Jersey
Posted:
November 24, 2016
Reference:
1042960


About the company
A career at the company offers opportunity, ownership and impact.

All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
The Global Medical Lead- Better Breathing, is an integral member of the Better Breathing team. The Better Breathing Lead combines medical expertise and understanding of the consumers, patients and physicians point of view.

This role leads the development of medical strategy, planning and execution for all products in the better breathing category through demonstrated medical excellence, deep category science and data knowledge, and a strong understanding of the perspectives of patients and consumers. Brands in this area include Robitussin, Advil Cold & Sinus, Alavert, Dimetapp, Children's Advil.
The medical activities performed by the Better Breathing Lead will be in support of new product innovation driven by the Better Breathing team, plus SME support of marketed products. This role works in close partnership with the commercial Better Breathing Lead, Regional Medical Affairs, Clinical Development, Regulatory, Safety and other stakeholders.

Responsibilities
Therapy Area Support

• Collaborate with Better Breathing cluster lead to ensure integrated approach and alignment on product strategy

• Provide medical input on pipeline strategy, new product concepts and positioning

• Chair the Medical Strategy Working Group for Better Breathing. Accountable for medical strategy plans, medical rationales and assessments of new product innovation proposals

• Deliver medical rationales, benefit / efficacy statements, core science summaries and any medical materials required for submissions

• Collaborate with Clinical Research to ensure alignment on study design and optimize the probability of success

• Ensure appropriate Regional Medical Affairs input for medical strategy plan development

• Ensure alignment of global medical position to local product strategies and submissions

• Accountable for Regional Medical Affairs claims alignment

• Provide knowledge transfer of science through the explanation and documentation of substantiations, references and core science summaries

• Assess local claim concepts and suggestions

Medical Excellence Deliverables

• Own medical deliverables for marketed product support for entire therapeutic area portfolio including:

• Core data sheet and labeling assessments, labeling changes, rapid response teams, health hazard assessments, risk management plan updates, RMC/BUBRC, annual reports (PBRER's, etc.)

• Engage with important external medical and scientific leaders in support of medical strategy

• Lead in organization of global external meetings including advisory boards, congresses and symposia

• Support Regional Medical Affairs to represent PCH Medical's point of view in health authority meetings

• Monitor publication landscape and scientific trends to serve as trusted resource of accurate, current medical and scientific knowledge including competitive products

• Serve as subject matter expert within therapeutic area, including the company OTC and Rx products, competitive products and competitive intelligence

• Develops scientific publications strategy, manages and progresses milestones.

• Authors Investigator Initiated Research (IIR) strategy document, provides oversight and approval

Qualifications
Advanced degree, including PhD, and/or PharmD or equivalent qualifications.

Proven experience in therapeutic areas such as Respiratory, Cough, Asthma, Allergy, etc.

A strong strategic mindset, excellent communication skills, relationship building capabilities and excellent ability to influence across the organization are required.

10-15 years of pharmaceutical industry experience spanning Clinical Research and Medical Affairs. Experience in Consumer Healthcare preferred.

5+ years of management/leadership experience.

Proven ability work successfully in a large, matrixed global organization.

Proven ability to facilitate open discussion and debate among key stakeholders and build internal internal and external relationships through partnering, anticipating needs, fulfilling expectations.

Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.

EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
A little about us:
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