Manager, Medical Writing

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Job Summary:

Position is responsible for the preparation of protocols, Investigator Brochures (IBs), Clinical Study Reports (CSRs), clinical sections of the CTD (2.5, 2.7.3, 2.7.4), integrated summaries of efficacy and safety (ISE and ISS), briefing books, and regulatory responses. The position will be responsible for hands-on writing and may oversee work performed by CRO/consultant writers. Documents must be of high quality in terms of scientific content, organization, clarity, accuracy, format and consistency, and adherence to regulatory requirements and company guidelines/styles/processes. In addition, this position has the potential to be a lead writer for protocols, reports, and IBs. As a content expert, this position has a significant understanding of regulatory requirements and ICH guidelines (including E3 and E6), and basic knowledge of document management systems.

Responsibilities:

Serves as primary author on a wide variety of clinical documents (protocols, reports, investigator brochures, etc.), with guidance as needed from functional area experts. May coordinate medical writing activities of external writers with regards to company document templates, standards, and processes; Review documents produced by external writers for scientific content and alignment with company position, clarity, accuracy, and consistency; Act as liaison between internal and external reviewers and the external writer; Organizes and leads cross-functional meetings to determine timelines and processes for protocol and report development; Addresses QC findings on documents with minimal input from functional area experts

Writes high-quality first-draft content with minimal input from functional area experts; Understands clinical data and uses text, tables, and figures as appropriate to accurately and effectively convey key messages; Participate in appropriate development teams and internal strategy and operations meetings

Serves a point of contact with CRO or contract medical writer on projects; Ensures that documents written externally conform to company standards and style

Participates in development of medical writing processes and working standards; Uses knowledge of document development best practices to continuously improve medical writing SOPs, templates, style guide, etc.

Provide independent document quality control services for documents on which the writer has no other role; Check electronically published CSRs for completeness (appendices and required signatures present) and adherence to company's electronic publishing standards before archiving

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

Bachelor's Degree in a relevant science; Graduate Degree (Masters or Doctorate preferred) in a relevant science

• Regulatory Medical writing experience required
• 2+ years of experience with a Graduate Degree
• 5+ years of experience with a Bachelor's Degree
• Have good organizational, interpersonal and communication skills
• Ability to manage processes and organize priorities; Foster collaboration to resolve conflict
  Have a working knowledge of PDF, and Project. Skilled in use of MS WORD. Have used 1 or more EDM systems
  
  Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Job Title
Manager, Medical Writing

City
Basking Ridge

Functional Area
Regulatory Management Operations

State
New Jersey