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Associate Director, Medical Writing

Company: Alexion
Location: New Haven
Posted on: November 19, 2021

Job Description:

Career Opportunities: Associate Director, Medical Writing (26326) Requisition ID--26326-----Posted--10/11/2021----- Country (Multi Selection) (1) ----- City (Multi Selection) (2) -----Biostatistics, Clinical Data Management, & Programming Some opportunities happen only once in a lifetime - like a job where you have the chance--to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients. This position can be based from any of the following Alexion locations; Boston, MA, Wilmington, DE or New Haven, CT. This is what you will do: This position is accountable for the timely preparation of high quality, regulatory-compliant clinical document deliverables for Alexion. This position will lead the medical writing (MW) activities across a disease area or set of clinical programs. This position will function with moderate supervision. The scope of this position includes the writing, document management, and development support for clinical study-related documentation including, but not limited to, clinical study protocols, Investigator's Brochures, and clinical study reports; and to collaborate with cross-functional teams to write and development regulatory submission documents, risk management plans, briefing books, regulatory response documents, pediatric investigational plans, and other IND/CTA or global regulatory submission documents. You will be responsible for:

  • Authors and manages the completion of clinical documents and other assigned tasks within established timelines with highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. Clinical document types include clinical study protocols, clinical study reports, Investigator's Brochures and updates, clinical Common Technical components (includes Module 2 summaries), risk management plans, contributions to briefing books, response documents, pediatric investigational plans, and other IND/CTA or global regulatory submission documents.
  • Supports development and implementation of strategy for writing and completion of high quality clinical documents.
  • Actively supports clinical project team(s), representing MW, and takes responsibility for timely and accurate MW deliverables, negotiating timelines as necessary.
  • Participates with other MW team members to develop and support process and standards to be implemented, and takes responsibility for execution across cross functional teams.
  • Maintains adherence to uniform processes and standards in partnership with statistical, clinical, regulatory and pharmacovigilance colleagues.
  • Develops effective collaborations with other functional lines in Alexion, and externally with regulatory, industry, professional, and academic organizations.
  • Reviews, edits, and ensures quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensures adherence to standards.
  • Ensures that all activities are conducted in compliance with relevant regulatory requirements. You will need to have:
    • MS degree in life sciences or equivalent required
    • At least 5 years medical writing experience or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge
    • Experience with global trials and regulatory submissions preferred
    • Experience with partnering and managing CRO relationships a plus
    • Proven excellence in operational strategy; experience with developing, implementing, and measuring the impact of MW processes and systems across multiple projects
    • Experience desired in MW for rare diseases and capability to develop and implement innovative solutions for optimizing MW for rare disease studies The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; problem solve; engage in complex and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours. We would prefer for you to have:
      • Advanced degree in a relevant scientific/clinical/regulatory field preferred Alexion--is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further--information about Alexion can be found . Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack--thereof, sex, sexual--orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, parental status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an--interactive dialogue with Alexion regarding an accommodation, please contact Alexion participates in E-Verify. As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click--here .

Keywords: Alexion, New Haven , Associate Director, Medical Writing, Advertising , New Haven, Connecticut

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