Pfizer OFG in Mumbai, India

ROLE SUMMARY

  • Leads a team of medical professionals responsible for critical support functions for the EMB Global Medical Affairs and Product Evaluation team out of India.

  • Reports directly to the EMB Products and Product Evaluation Global Medical Head

  • Ensures delivery of all required activities within expected timelines and on budget

ROLE RESPONSIBILITIES

Leads a team of medical professionals that will be responsible for providing support to the EMB Global Medical Affairs team, specifically:

  • Researching literature databases and internal and external repositories to support the evaluation of Health Hazard Assessments and the benefit-risk of Pfizer products

  • Author documents that include major regulatory agency submissions, clinical overviews, health hazard assessments, listings and summaries of the results of the above research to the required standard

  • Reviews the produced documents for relevance and compliance

  • Reviews therapy area sales training material for accuracy and alignment with Core Claims, Common Technical and/or other regulatory documents

  • Reviews promotional material to ensure it is accurate, truthful, not misleading and aligned with Core Claims, Common Technical and/or other regulatory documents

  • Other Medical Affairs activities as required - the role of the team is expected to grow over time as it assumes more Medical Affairs roles

  • Ensures delivery of all required activities within expected timelines and on budget

  • Maintains the highest standards of training and compliance within the team

  • Establishes and attains agreed key performance indices for the relevant activities

QUALIFICATIONS

Education:

  • MD/MS degree- any specialization or MBBS ( Medical Graduates only)

  • 10+ years of experience in the pharmaceutical industry or Regulatory Affairs.

  • Strong (5-10 yr) clinical practice experience, with preference to US, EU qualifications, (internal medicine, emergency medicine, other specialty)

  • Advanced understanding of medical concepts of the disease and extensive knowledge of current standard treatments in the disease area and apply in a patient oriented approach.(medical experience)

  • Strong experience in medical, scientific and regulatory writing.

  • Able to design, interpret, integrate and synthesize complex analyses of medical, scientific and safety data to address key messages and activities and impact on benefit risk (analytic skills)

  • Skilled at using tools such as OvidSP and other bibliographic databases such as PubMed, Medline, Embase, and Biosis. (technical skills)

  • Understands regulatory guidance as it pertains to presentation and communication of benefit/risk and pharmacovigilance (regulatory knowledge)

  • Synthesizes analyses of complex medical and scientific data into clear skillfully written text without supervision. (writing skills)

  • Understands medical concepts of the disease and the specific approach to treatment. (medical knowledge)

  • Makes decisions that require developing an innovative strategy or choosing between multiple options to resolve complex problems. (analytic skills)

  • Has extensive understanding of place of product benefit/risk in commercial and medical setting (analytic skills)

Technical qualifications

  • Regulatory knowledge: Familiarity with global regulatory guidance (especially ICH, FDA and EMA) relevant to clinical and safety data and clinical development and labeling.

  • Writing skills: Excellent scientific writing skills, including an ability to summarize and interpret complicated data effectively, concisely and persuasively.

  • Analytic skills: Ability to examine data, formulates reasonable hypotheses, and design and execute analyses to test them.

  • Oral presentation skills: Strong oral presentation skills, including ability to present, explain and defend data analyses before internal and external (including Regulatory Authority) audiences

  • Language skills: High fluency in written English and strong functional fluency in spoken English.

  • Personal skills: Strong organizational skills and ability to prioritize multiple projects and meet deadlines.

  • Interpersonal skills: Effective influencing and negotiating skills, including when appropriate an ability to guide decision-making for document content strategy. Ability to work well with all levels and roles in cross-functional, global teams. Ability to mentor more junior colleagues and external vendors.

  • Software: Previous experience with software commonly used to present and analyze data (Word, PowerPoint, and Excel) is preferred.

Epidemiology: Extensive familiarity with epidemiologic principles and concepts is desirable.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Travel of 25-30% required

Other Job Details:

  • Last Date to Apply for Job: January 20, 2019

  • Additional Locations: Mumbai, India

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.