Medical Writer Assoc Director

Employer
Celgene
Location
San Diego, CA
Posted
Jun 05, 2018
Ref
1801515
Required Education
Masters Degree/MBA
Position Type
Full time

Other Locations:US- CA- San Diego- Science Park


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.

This position prepares or manages the development of all clinical and regulatory documents, publications, and conference materials. This position builds strong relationships with Regulatory Affairs, Biostatistics, Clinical Operations, Clinical Development, Project Management, and other functional areas.

Major Responsibilities:

  • Author, co-author, critically edit, and format regulatory documents including NDAs, MAAs, INDs, protocols, CSRs, Investigator Brochures, annual reports, briefing documents, and other regulatory submissions;

  • Author, co-author, and critically edit publications including abstracts, posters, slide presentations, manuscripts, and review articles;

  • Manage medical writing contracted with independent consultants, CROs, and other communication vendors;

  • Manage overall medical writing timelines and resources across project teams (including internal and external resources);

  • Serve as the functional area lead on project teams and advise such teams on content, format, and style-guide requirements for documents;

  • Lead the development of medical writing processes, SOPs, work instructions, and document quality control;

  • Participate in the development of publication plans;

  • Manage the hiring, supervising, mentoring, and development of internal medical writing staff as the function expands;

  • Maintain subject area expertise related to the company's investigational products, disease indications, and regulatory and publication guidelines;

  • Develop a budget for the medical writing department; and

  • Willingness to perform miscellaneous job-related duties and additional duties and responsibilities as assigned.

Knowledge, Skills and Abilities Required:

  • Advanced degree in life sciences required (MS, PhD, Pharm D, or equivalent);

  • 8 years or more of medical writing experience in the pharmaceutical or biotechnology industry;

  • Demonstrated success managing medical writers (in-house and contract);

  • Previous leadership role in major regulatory filings (NDA, BLA, MAA);

  • Excellent ability to interpret and present scientific and clinical trial data and understand statistical analyses;

  • Excellent writing skills coupled with comprehensive knowledge of the drug development process and regulatory guidelines;

  • Effective collaborator possessing the ability to foster strong working relationships and build consensus within multidisciplinary teams;

  • Demonstrated initiative and the ability to manage a variety of projects simultaneously with minimal supervision;

  • Excellent interpersonal and communication skills;

  • Advanced knowledge of clinical and regulatory documents and publication practices including GCP, ICH, ICMJE, and CONSORT; and

  • Expert user of Microsoft Word, PowerPoint, and Excel

  • Key Competencies:
    • Professionalism and customer service orientation

    • Communication skills - written and verbal

    • Planning, organizing and multi-tasking

    • Prioritizing and time management

    • Problem assessment and problem solving

    • Information gathering and information monitoring

    • Attention to detail and accuracy

    • Flexibility, adaptability and teamwork


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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.