Director, Medical Writing

  • Company: Pfizer
  • Location: Groton, Connecticut
  • Posted: December 08, 2017
  • Reference ID: 1616326

The Director, Medical Writing is a key member of the Clinical Communications team within the Medical Writing department. The role has oversight for protocols, clinical study report (CSRs), and data disclosure documents for multiple therapeutic areas and/or business units. This includes directing, authoring, and reviewing documents. The role is responsible for managing and developing staff to establish strategic, scientific, and technical expertise to support delivery of high-quality documents. The incumbent will champion new medical writing support models as well as efficiency initiatives related to document development. The role requires innovative problem solving, influencing peers, and change management. Responsibilities Provide strategic leadership to study teams to direct the preparation of protocols, CSRs, narratives, and data disclosure documents (basic results summaries, public disclosure synopses, and patient lay summaries) that are well-written, accurate, and consistent. Demonstrate in-depth knowledge of regulatory writing and data disclosure requirements. Author and review documents as needed. Direct the work of internal medical writers and medical writing specialists. Manage external writing resources. Provide coaching and training to Pfizer colleagues to support performance management and career development. Effectively interact within a matrix organization to forecast, manage, and prioritize document deliverables to support portfolio goals in multiple therapeutic areas and/or business units. Promote open communication regarding medical writing status and issue resolution. Manage risk appropriately to enable innovative solutions that maintain high-quality deliverables. Work closely with Medical Writing management to establish new medical writing support models and implement strategies to improve operational efficiency. Apply relevant experience in process initiatives, technologic improvements, and/or vendor management. Participate and/or lead business processes to support functional excellence, quality, and innovation. Qualifications At minimum Bachelor's degree or equivalent in medical-related field or life science. Post-graduate degree preferred. BS/BA +15 years, MS/MA +13 years, PhD +10 years of relevant experience in the Pharmaceutical or Biotech industry. Comprehensive understanding of the drug development process. Medical writing experience in protocols, CSRs, and data disclosure deliverables (e.g.,, EudraCT, EMA Policy 70). Excellent project management skills. Proven ability to manage medical writing deliverables for multiple studies or programs. Experience in people management and talent development Experience working with vendors. Excellent interpersonal, communication, and negotiation skills. Proven ability to establish and maintain professional and productive working relationships. 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: 16 Additional Location Information: New York, NY; Collegeville, PA; Peapack, NJ; Groton, CT; San Francisco, CA; or any other US Pfizer site; can also 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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