Senior Manager, Medical Writing in Watertown, MA at APEX Systems

Date Posted: 11/21/2019

Job Snapshot

Job Description

Job #:  1014528
 Senior Manager, Medical Writing, 1014528
Job Scope & Purpose:
Our client is seeking an experienced, motivated Senior/Medical Writer to join a growing team! The research and development activities use a robust, chemistry-driven approach in the development of small molecule drugs for the treatment of viral infections and liver diseases. This experienced individual would step into a newly created position that will report to and partner with the Associate Director of Medical Writing. The Medical Writer or Senior Medical Writer will be responsible for the medical writing deliverables in support of our client’s clinical portfolio and assisting in preparing moderately complex clinical study documents (i.e. clinical study protocols/amendments, clinical study reports, investigator’s brochure), abstracts/manuscripts and sections of regulatory submissions necessary for early phase clinical drug development. The Medical Writer contributes their scientific knowledge and analytical skills to the preparation of clinical regulatory documents and will produce high quality and timely writing deliverables, ensuring scientific consistency between related documents or studies in a clinical program. This is an opportunity to join a small team and develop your career!
Primary Job Responsibilities:
  • In coordination with the Clinical & Regulatory groups, draft, edit, format, and finalize clinical protocols/amendments, investigator’s brochures, clinical study reports, and sections of IND submission documents. Other documents may include health authority briefing books, and scientific publications, abstracts/presentations.
  • Provide QC of clinical and regulatory documents including data output.
  • Produce high quality and on-time writing deliverables ensuring scientific consistency between related documents or studies in a clinical program.
  • Ensure a consistent style for the presentation of clinical documents in order to maintain quality and ease of review, and adherence to company standards.
  • Facilitate efficient review and finalization process of clinical documents produced internally and externally by consultants/contractors and vendors.
  • Perform clinical literature searches related to documents in development.
  • Perform other duties as assigned.

Primary Job Requirements:
  • MS or PhD in a relevant scientific field is strongly preferred.
  • Minimum of 2+ years of medical writing experience in a pharma, biotech, or CRO setting is required
  • In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
  • Strong computer skills (Word, Excel, PowerPoint, and Adobe Acrobat) and the use of templates.
  • Experience with regulatory submissions (CTA/IND) and knowledge of eCTD formatting is a plus.

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
 
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. 
 
jprice@stratacuity.com
 
Code: ClinOps
 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.