Senior Manager Medical Writing

Company: Ascent Services Group
Location: San Diego
Posted on: April 8, 2021

Job Description:

We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission to identify, develop and deliver life-changing therapies to people living with rare disease. We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community.



Position Summary:
The Senior Manager, Medical Writing is responsible for oversight and authoring (if needed) of regulatory, clinical, and safety documents, including protocols and amendments, clinical study reports (CSRs), Investigator's Brochures (IBs), Common Technical Document (CTD) sections, and Periodic Safety Update Reports (PSURs). This position is expected to contribute directly to the drafting of high level (eg, Module 2) submission documents and be responsible for overall project management during the drafting, reviewing, and approving cycles of documents. This position will oversee the drafting of documents that are compliant with company-specific medical writing standards, are completed on-time and on-budget, and are ready for submission to global, regional, and local regulatory authorities. Additionally, this position will support projects across all phases of clinical development and post-marketing life cycle management.
Essential Functions:

• Lead the overall strategy and execution of medical writing projects in support of therapeutic development programs.
• Collaborate with cross-functional team members to ensure accurate and timely completion/delivery of high-quality, scientifically-justified documents.
• Responsible for the scientific accuracy and regulatory quality assurance of developed content and deliverables.
• Responsible for implementation of medical writing review processes.
• Communicate deliverables needed, writing process, and timelines to team members.
• Contribute to the development and standardization of templates and related processes and assist in the development of templates, style guides, and SOPs for regulatory writing.
• Maintain expert knowledge of US and international regulations, requirements and guidance associated with clinical, regulatory, and safety document preparation and submissions.
• Lead and manage comment resolution meetings.
• Learn and apply knowledge of therapeutic area and product to scientific writing projects.
• Develop, maintain, and drive document finalization timelines and coordination of document review. Qualifications:
  • Master's, PhD or PharmD in Life Science disciplines; equivalent combination of education and applicable job experience may be considered.
  • Minimum 4 years of progressively responsible medical writing experience in a biopharmaceutical/industry environment or 6+ years at a Contract Research Organization (CRO) or related environment .
  • Proficiency with Microsoft Office, and VEEVA platforms and use of Starting Point electronic document templates.
  • Time management and project management skills are essential.
  • Knowledge of FDA, EMA, ICH, and other applicable guidelines and regulations.
  • Experience or background in working within the pharmaceutical industry, awareness of compliance issues and guidelines around medical education and publications.
  • Ability to manage various projects, solve problems, deliver on commitments and work with multidisciplinary teams.
  • Independent, self-starting individual with a demonstrated ability to thrive in smaller company culture and environment is required.
  • Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
  • Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity. Divna Rosenzweig is recruiting for this position. Corporate Office
    1001 Galaxy Way, Suite 405
    Concord, CA 94520
    925-627-4900
    info@ascentsg.com Employment Verifications
    Via The Work Number, employer code 105779 Additional office locations in Chico, CA; Chicago, IL; Los Angeles, CA.

Keywords: Ascent Services Group, San Diego , Senior Manager Medical Writing, Healthcare , San Diego, California