Senior Medical Writer


Job ID 18-00013

Industry Pharma

Job Type Contract

Location Cranbury, NJ

Description

POSITION SUMMARY
The Senior Medical Writer (Contract) will be responsible for providing high quality medical writing, including efficient project leadership, for one or more clinical trials and also authoring and reviewing submission-level clinical/regulatory documents. The person in the contract position of Sr Medical Writer may be responsible for the expanded development, implementation, and maintenance of operations related to clinical trial registration and results disclosure. 

ROLES AND RESPONSIBILITIES

  • Authoring documents in a clear and accurate manner consistent with the target audience and regulatory requirements
  • Planning and coordination of timelines, meetings, and facilitation of cross-functional communication and contribution
  • Analyze, interpret, and accurately present data in text, table, or figure format, as needed
  • Assisting with responses to questions from regulatory authorities (eg, MAA and FDA)
  • Contribute to regulatory submissions by authoring relevant sections of eCTDs (eg, ISS, Summary of Clinical Safety)
  • Performing quality-checks of documents for agreement between in-text and source data
  • Editorial review of documents, including submission-compliant formatting
  • May be involved with the development, implementation, and maintenance of operations related to clinical trial results disclosure including authoring, collaborative review and revision, quality control activities, approval, and release/publication for public disclosure
  • The candidate must be able to work independently and efficiently with cross-functional team members. Reliance on instructions, templates, and pre-established SOPs and guidelines will be expected to perform the above functions.

 

TRAVEL

  • 0-5%


Qualifications

REQUIREMENTS

  • Bachelor's degree in a scientific discipline plus a minimum of 5-7 years industry experience.
  • Master's degree in a scientific discipline plus a minimum of 2-5 years industry experience.
  • Ph.D, Pharm.D, or equivalent in a scientific discipline plus a minimum of 1-2 years industry experience.
  • Previous experience at a pharmaceutical or Clinical CRO company is required.

EXPERIENCE AND SKILLS

  • This position requires translating technical information from mixed sources into written information suitable for an audience of regulatory authorities and clinicians. It will be essential to approach issues from a number of perspectives, summarizing data to draw a conclusion.
  • The ideal applicant would have training in the biomedical sciences, particularly in areas such as biology, pharmacology, chemistry and biotechnology, as well as experience in technical written communication.
  • As a lead author, this person must work cross-functionally with appropriate teammates to create, coordinate review of, and edit through finalization required regulatory clinical summary documents.
  • The applicant would have previous experience leading and writing submission-level documents, including familiarity with eCTD format and associated guidance's.
  • The exercise of good judgment in the incorporation of review comments from multiple individuals will be needed.
  • The applicant must be able to prepare deliverables in accordance with pre-established timelines and specifications, systematically performing activities in a timely and accurate manner.
  • A commitment to accuracy of data presentation and ever improving the clarity of communication is essential.
  • This writer will also engage in the project management of document support activities by others (QC and publishing) to deliver high-quality submission-ready documents in accordance with the agreed timelines.
  • Advanced writing competency, positive and proactive communication skills, proficiency with Microsoft Office Suite, and high attention to detail are essential.
  • The applicant is desired to have previous experience in the writing and development of clinical trial results postings. This person must work cross-functionally with appropriate teammates to create results postings, coordinate their review, and edit through finalization.
  • The applicant is desired to have experience in writing and reviewing standard operating procedures.
  • A good understanding of medical terminology and AMA style is needed