Director Nonclinical and Clinical Pharmacology Writing
Director Nonclinical and Clinical Pharmacology Writing
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Job Description
This is what you will do:
This position is accountable for the timely delivery of highquality nonclinical and clinical pharmacology (NCCP) regulatory documents supporting the clinical development portfolio at Alexion. This position will lead the NCCP writing activities across a disease area or set of clinical development programs. This position will function with limited supervision.
You will be responsible for:
- Lead development and implementation of document strategy for NCCP regulatory documents including but not limited to earlystage protocols Investigators Brochures module 2 summaries for IND/CTA/NDA submissions.
- Contribute to the development of briefing packages responses to health authority inquiries and other IND/CTA or global regulatory submission documents.
- Author and manage highquality NCCP MW in terms of scientific content organization clarity accuracy format consistency and adherence to regulatory and internal guidelines styles and processes. Represent MW crossfunctionally negotiating timelines as necessary. May function as submission and/or program lead.
- Review to ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards.
- Mentor MW team members (internal and external) ensuring quality and efficiency in the production of NCCP regulatory documents.
- Ensure consistent support and implementation of MW standards and maintain adherence to standard operating procedures and regulatory requirements in partnership with nonclinical statistical clinical regulatory quality and safety colleagues.
You will need to have:
- At least 10 years of regulatory MW experience authoring and leading global regulatory submissions.
- Demonstrated capability to summarize complex data and write regulatory documents.
- Excellent oral written and presentation skills; advanced user of MS Office suite.
- Thorough knowledge of global regulatory requirements and ICH/GCP guidelines.
- Demonstrated aptitude for managing the work of external and/or internal medical writers as well as training and fostering development of less experienced staff.
- Welldeveloped sense of ethics responsibility and respect for others.
- The duties of this role are generally conducted in an office environment. As is typical of an officebased role employees must be able with or without an accommodation to: use a computer; engage in communications via phone video and electronic messaging; engage in problem solving and nonlinear thought analysis and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
- PhD or MS degree in life sciences or advanced degree in a relevant field.
- Broad experience with global clinical studies and regulatory submissions.
- Ability to establish excellent internal and external relationships with subject matter experts alliance partners and vendors.
- Skilled at planning budgeting and project management as well as problem solving organization and negotiation.
- Experience in rare and ultrarare diseases.
- Resultsdriven and with high standards of excellence for self and others.
- High level of flexibility and ability to innovate and adapt to changing conditions.
Date Posted
21oct2024Closing Date
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 lackthereof sex sexualorientation age ancestry national origin ethnicity citizenship status marital statuspregnancy (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 aninteractive dialogue with Alexion regarding an accommodation please contact . Alexion participates in EVerify.
Required Experience:
Director
Employment Type
Full-Time
