Director, Medical Writing

Recruiter
Arena Pharmaceuticals, Inc.
Location
San Diego, California
Posted
Oct 31, 2019
Closes
Nov 14, 2019
Ref
2143cf078c00
Organization Type
Corporate
Description

The Director of Medical and Scientific Writing is responsible for leading the writing activities resulting in delivery of technical documents to key stakeholders and product development teams within Arena. Documents within the scope of the role include regulatory submission documents supporting product development and marketing applications. The position will lead and participate in writing activities tied to clinical, nonclinical, safety and regulatory documents according to applicable regulations and internal guidelines. This leadership role will provide guidance and expertise to the medical writing function and will serve as the medical writing subject matter expert to the organization. The Medical Writing function is a key collaborator with clinical, nonclinical, safety, regulatory affairs and medical affairs to ensure content is appropriate and within guidelines.

Essential Duties and Responsibilities
  • Lead the provision of services provided by the Medical and Scientific Writing group; accountable for the group's performance within the organization and the development of individual contributors within the group
  • Engage in product development team forecasting and planning for all program-specific document deliverables
  • Partner with the clinical team and other key stakeholders to prepare protocols, clinical study reports, informed consent forms, and investigator brochures
  • Partner with the regulatory team to prepare other documents such as health authority meeting briefing packages, CTD summaries and overviews, and annual reports
  • Provide product development teams with expertise on regulatory requirements and corporate procedures and standards controlling documents for regulatory submission
  • Provide product development teams with expertise and strategic guidance on analysis and presentation of clinical and safety data and on benefit-risk assessment in documents
  • Provide oversight of document quality and consistency; ensure efficient formatting of documents as well as consistent style of presentation to maintain quality and ease of review across multiple documents assembled in a regulatory dossier or briefing package
  • Contribute to overall project management and cross functional working groups as needed to facilitate efficient development and finalization of clinical, nonclinical and regulatory documents for submissions
  • Identify and participate in development and improvement of key business processes related to medical and regulatory writing, as required
  • Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams, leadership and key stakeholders in a timely manner of any deviations or potential deviations
  • Ensure continuous awareness of the medical writing activities, plans, scope of work and ways of working across the organization
  • Track progress against targets; produces timely and accurate status update reports
  • Build and maintain positive working relationships with key stakeholders, team members and vendors

Education
  • Bachelor's degree in a related field required; advanced degree preferred

Experience
  • Minimum of 10 years of relevant and progressive experience in biotech/pharma/scientific company required
  • Experience in a leadership role within a Medical Writing function; experience having responsibility for the performance and development of staff
  • Experience developing document development processes and document standards
  • Recent and significant experience in writing regulatory documents such as Clinical Study Reports, Protocols as well as Summaries and Overviews for INDs or marketing applications
  • Significant to advanced experience using Microsoft Office Suite including Word, Excel, Power Point and Outlook required; experience with SharePoint and Veeva RIM Vault is preferred

Specific Skills
  • Ability and passion to work in a demanding, dynamic, fluid and fast-paced environment
  • Ability to contribute to discussions of benefit/risk assessment and regulatory impact of documents and analyses
  • Advanced understanding of medical concepts as they relate to clinical trials; significant familiarity with medical terminology
  • Demonstrated ability to interpret complex analyses of data supporting regulatory submissions
  • Demonstrated ability to act/think strategically and see "the big picture", all the while being hands on
  • Demonstrated ability to communicate and write English clearly, concisely, and effectively
  • Demonstrated ability to lead and drive others; manage without authority
  • Demonstrated ability to serve as a subject-matter-expert on the interpretation of regulatory guidance and its significance in a broad range of situations
  • Travel up to 10% (US and International)

Supervisory Responsibilities: Medical Writing group