AD/Director Medical Writer in Cambridge, MA at Apex Life Sciences

Date Posted: 10/30/2018

Job Snapshot

Job Description


Job Scope & Purpose:

Seeking a strong Director/AD level Medical and Technical Writer for our client, a growing gene therapy company here in Boston!  Reporting into the Head of Regulatory, the ideal candidate will have at least 10 years in drug development (minimum 5 years in medical writing) within the biotech or pharma industries.   Experience in the preparation of protocols, study reports, investigator brochures, safety updates, IND clinical sections and briefing books for health authorities is desired.  The ideal candidate will be agile, self-motivated, and have a proven record in a fast-paced environment.  

Primary Job Responsibilities:

  • Serve as the medical writer contributing to a variety of clinical documents for clinical and regulatory purposes, including clinical protocols, clinical study reports, investigator brochures, and regulatory submissions including briefing books
  • Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents.
  • Ensure that all deliverables are in accordance with regulations, standards, and guidelines. The regulatory documents must meet ICH, GLPs, and GCPs guidelines, a writing style guide, and often a company template.
  • Provide support for QC of documents
  • Contribute to overall project management and to cross functional working groups as needed to facilitate efficient development and finalization of clinical, nonclinical and regulatory documents for submissions
  • Communicate with team stake holders to maintain awareness of expectations, milestones, and deliverables.
  • May include participation in initiatives such as document templates, writing style guide, and support for document reviewing/authoring tools
  • Manage the work of CRO contract writers, as needed

Primary Job Requirements:

  • PhD in a Life Science or equivalent preferred, Master’s or Bachelor’s Degree considered based on experience level.
  • At least 10 years in drug development of which at least 5 years in medical writing, including participating in submissions to the US FDA (IND, NDA, BLA), EMA (MAA) and EU National Health Authorities (IMPD/CTA)
  • Experienced in the preparation of protocols, study reports, investigator brochures, safety updates, IND clinical sections and regulatory submissions including briefing books
  • Wide knowledge of biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology
  • Thorough understanding of FDA and ICH regulations and guidelines
  • Understanding of the level of evidence required to achieve regulatory, marketing and regulatory goals.
  • Ability to interpret and present clinical data and other complex information
  • Excellent written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy
  • Demonstrated ability to communicate clearly, concisely, and effectively
  • Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high quality documents according to tight timelines
  • Accurate and detail-oriented
  • Independently motivated, and good problem-solving ability
  • Ability to work with multiple contributors to produce a final unified document
  • Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) and experience and skill performing medical literature searches

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 at info@stratacuity.com or 877-787-2821.

Code: DiscDevt

EEO Employer

Apex 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. 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.




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