Pharma GMAIST Medical Manager Post Vacancy @ Pfizer

Pharma GMAIST Medical Manager Post Vacancy @ Pfizer

Pharma GMAIST Medical Manager. Pharma Manager Job. Manager Post vacant @ Pfizer. Pfizer 2019 Jobs, Pfizer Medical jobs, Pharmaceutical Science jobs 2019. Pfizer hiring M Pharma candidates Pharmacy vacancy. Interested and eligible candidate can apply for this post. Check out all the details on the same below:

Job Title: Medical Manager – GMAIST

Job Id: 4762721

Eligibility: B Pharma/ M Pharma

Experience:

  • 3 to 4 years of relevant experience for medical graduates, PhDs & masters in life sciences/ more than 6 years of relevant experience for science graduates.
  • Minimum 3 years of experience in medical writing within an agency, CRO, Pharma / Biotech Company.
  • Prior experience in using search tools, developing search strings and assessing search results is preferred.

REQUIRED SKILL SET

Technical:

Writing skills: Excellent scientific writing skills, including an ability to summarize and interpret complicated data effectively, concisely and persuasively.
Analytic skills: Utilize tools such as OvidSP and other bibliographic databases such as PubMed, Medline, Embase, and Biosis. Ability to examine data, formulate reasonable hypotheses, and design and execute analyses to test them.
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.

Regulatory knowledge: Familiarity with global regulatory guidance especially International Conference on Harmonisation (ICH), Food and Drug Administration (FDA) and European Medicines Agency (EMA) relevant to clinical and safety.

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

Epidemiology: Familiarity with epidemiologic principles and concepts is desirable.

The Medical Manager supports and partners with GMPE Therapeutic Area (TA) Leads and Global Medical Affairs by:

  • Creating documents pertaining to clinical data, company data, published literature and other data to support the maintenance and defense of our products. Some examples of such document include briefing documents to support meetings with regulatory agencies, clinical overviews and clinical efficacy section in support of Periodic Benefit
  • Risk Evaluation Reports (PBRERs), Addendum to Clinical Overviews (ACOs), Periodic Safety Update Reports (PSURs), Addendum Reports, Health Hazard Assessments Clinical Evaluation Reports, Hazard Analysis, critical review and analysis of the medical literature and responses to clinical and safety questions from regulatory authorities.
  • Providing expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents.
  • Assessing document requirements, gauging document complexity, and identifying information gaps or other potential issues. In collaboration with the relevant GMPE TA Lead, the author proposes or contributes to strategies to resolve any identified issues.
  • Clinical and scientific medical writing, editing, and quality control (QC) review for regulatory documents including clinical study reports, safety narratives, protocols, protocol amendments, investigator brochures and submission documents.
  • Pharmacovigilance and drug safety writing including: Periodic Adverse Drug Experience Reports (PADERs), CERs, PSURs, and Development Safety Update Reports (DSURs).
  • Manuscript writing including researching, organizing, compiling, interpreting and quality checking various types of technical and/or medical information.
  • Medical communication writing including research and authoring of global medical standard response letters (“Dear Doctor” letters).
  • Creating slides, abstracts, training materials, and style guides, as needed for our clients and their diverse audiences.
  • Adapting writing to different types of clients and audiences from the health care professionals and technical people to the consumer audience.
  • Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams in a timely manner of any definite or potential deviations.
  • Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
  • Deliver assigned documents on or before deadline, alerting project teams in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality.
  • Understand relationships and dependencies between documents and analyses produced for regulators, e.g., Risk Management Plans (RMPs), CERs, Hazard Analysis, Benefit-Risk Assessments, DSURs, PBRERs and ACOs.
  • Collaborate with other lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents.

Apply Online

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