Submission Medical Writer (Director)

  • Company: Pfizer
  • Location: New York, New York
  • Posted: December 08, 2017
  • Reference ID: 1616031

The Submission Medical Writer creates documents pertaining to clinical data and post-marketing safety data to support product development, license application, and post-marketing maintenance on behalf of and in conjunction with corresponding project teams. Some examples of such documents include briefing documents to support meetings with regulatory agencies, clinical documents for marketing authorization applications (Clinical Overviews and ICH module 2.7 clinical summaries, Integrated Summaries of Efficacy and Safety), and responses to clinical and safety questions from regulatory authorities. Responsibilities Provide project teams with expertise on regulatory requirements and corporate policies governing documents for regulatory submission. Provide project teams with expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents. Assess document requirements, gauge document complexity, and identify information gaps or other potential issues. In collaboration with the relevant project team, the author proposes or contributes to strategies to resolve any identified issues. Lead a team of internal or external (contractor) authors if multiple or complex documents are required for a particular project. Support project teams by providing analyses of clinical data. Communicate Medical Writing's position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed. Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams and line management in a timely manner of any definite or potential deviations. Drive document strategies and messages in a collaborative way with relevant project team subject matter experts. 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 and line management in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality. If leading a team of other authors (internal or external), be accountable for timely delivery of high-quality, fit-for-purpose documents to the project team. Produce documents in conjunction with external vendors. Review documents produced by vendors and help evaluate vendor performance. Understand relationships and dependencies between documents and analyses produced for regulators. Collaborate with quality lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents. Develop and sustain constructive relationships within other Pfizer lines including country organizations. If assigned by manager, serve as the Medical Writing 'point of contact' for all document issues for a given product or set of products. Identify potential areas for process improvements and possible solutions, and communicate these to line management or appropriate functional line. Qualifications Education Master's degree or doctorate or qualification in life sciences preferred. Alternatively, bachelor's degree in life sciences field with transferable skills and pharmaceutical industry experience, ideally in safety, regulatory or clinical areas. Experience and Ability BS/BA +15 years, MS/MA +13 years, PhD +10 years of relevant experience in the pharmaceutical or biotech industry with demonstrated experience leading the medical writing portion of regulatory submissions (NDAs and MAAs). Able to interpret complex analyses of data supporting regulatory submissions. Ability to serve as an authority on the interpretation of regulatory guidances and their significance in a broad range of situations. Expert ability to synthesize clearly written analyses of integrated patient data from single pivotal and multiple studies. Advanced understanding of medical concepts of the disease and extensive knowledge of current standard treatments in the disease area. Ability to contribute to discussions of benefit/risk assessment and regulatory impact of documents and analyses. Ability to make decisions by identifying innovative options or multiple solutions to complex problems. Recommends courses of action to management and senior leaders that impact the discipline, department or line. EEO & Employment Eligibility Pfizer 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. Pfizer 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. Pfizer is an E-Verify employer. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. Additional Offer Details: This job is Pfizer Exempt US Grade: 15 Additional Location Information: San Francisco, CA; La Jolla, CA; Peapack, NJ; Groton, CT; New York, NY; Collegeville, PA; can be remote based Eligible for Employee Referral Bonus A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer 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. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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