Associate Director, Clinical Narrative Lead

Employer
Celgene
Location
Summit, NJ, US
Posted
Sep 15, 2018
Ref
1803208
Required Education
Bachelors Degree
Position Type
Full time
Other Locations:US- NJ- Summit East

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Summary/Scope:

Co-Leads the overall Clinical Study Subject Narrative Process within the Hematology/Oncology Clinical Research and Development Function to deliver the Clinical Study Narratives to the study teams with efficiency, accuracy and within timelines.

Responsibilities will include, but are not limited to, the following:
  • In collaboration with other relevant line functions, lead the preparation of Clinical Study Subject Narratives through development to finalization.
  • Author and QC assigned Clinical Study Subject Narratives as needed.
  • Provide training and overall guidance to all narrative writers.
  • Attend all submission team meetings where narratives are required, and study team meetings as needed.
  • Provide representation of the narrative group within Velocity processes for narrative writing/listings/data cleaning.
  • Provide training/mentoring to all summer interns.
  • Assist the Senior Director of Clinical Science Operations with narrative automation and work with all functional groups as needed.
  • Lead all meetings relative to narrative automation between CROs, Programming and Clinical Science.
  • Assist the Senior Director of Clinical Science Operations with narrative study assignments, and monitor assignments for efficiency and completion.
  • In collaboration with other relevant line functions, lead the preparation of Clinical Study Subject Narrative Plans, TMF, and Clinical Study Subject Narratives for assigned studies.
  • Assist with CR&D departmental process management as needed.
  • Collaboration with clinical, safety and programming colleagues in developing the study specific narrative plan.
  • Review work of the narrative writers for accuracy, quality, focus and adherence to format, content and stylistic requirements.
  • Assist the Senior Director of Clinical Science Operations with management of the narrative writer contractors.
  • Manage time, mentoring, and answering of questions. Assist with hiring.


Skills/Knowledge Required:
  • BA/BS or equivalent degree preferably in life sciences or allied health field
  • At least 8 -10 years of experience in clinical research, clinical operations and/or drug safety roles, including a preference of at least 5 years of medical writing.
  • Experience in worldwide registration studies and large studies.
  • Experience in driving, managing and collaborating in a team/matrix work environment
  • Expertise in MS WORD, including the ability to solve technical problems with WORD templates.
  • Excellent grammatical and communication skills, both written and oral.
  • Ability to work with complex projects and within cross-functional teams.
  • Ability to anticipate and resolve problems.
  • Proficiency in data interpretation.
  • Experience working with automated data solutions in clinical documents.
  • Ability to work in a complex, fast changing environment.
  • Sound organizational skills.
  • Knowledge of FDA/ICH guidelines and industry standard practices regarding clinical research and development.


Key (PDI) Competencies:
  • Planning: Develops short and long-range plans that are appropriately comprehensive, realistic and effective in meeting goals; integrates planning efforts across work units.
  • Develops Systems & Processes: Identifies and implements effective processes and procedures for accomplishing work.
  • Effective Speaking: Speaks clearly and expresses self well in groups and in one-on-one conversations.
  • Listens to Others: Actively attends to and conveys understanding of the comments and questions of others; listens well in a group.
  • Displays Organizational Savvy: Develops effective give and take relationships with others; understands the agenda and perspectives of others; recognizes and effectively balances the interest and needs of one's own group with those of the broader organization.
  • Fosters Teamwork: Builds effective teams committed to organizational goals; fosters collaboration among teams; uses teams to address relevant issues.
  • Commitment to Quality: Emphasizes the need to deliver quality products and/or services; defines standards for quality and evaluates products, processes and/or services against those standards; manages quality.
  • Recognizes Global Implications: Seeks to understand issues, trends and perspectives of various cultures and countries; addresses cultural and geographic differences in strategies and approaches.
  • Demonstrates Adaptability: Handles day-today work challenges confidently; is willing and able to adjust to multiple demands, shifting priorities, ambiguity and rapid change; show resilience in the face of constraints, frustrations or adversity; demonstrates flexibility.
  • Analysis of Issues: Gathers relevant information systematically; considers a broad range of issues or factors; grasps complexities and perceives relationships among problems or issues; seeks input from others; uses accurate logic in analyses.
  • Innovation: Generates new ideas; goes beyond the status quo; recognizes the need for new or modified approaches; brings perspectives and approaches together combining them in creative ways.


*LI-POST

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.