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Sr. Director (Head), Medical Writing

Boston, MA, USA | Planet Pharma

  • Industry:
    HR / Recruitment Services
  • Position Type:
    Full-Time
  • Functions:
    General Management
    Regulatory Affairs
    Biotech/R&D/Science
  • Experience:
    10-12 years
Job Description:
64 people have viewed this job

The Clinical Development team at an Oncology focused early stage biotech is looking for an agile, selfmotivated,and experienced individual to serve as the Senior Director, Medical Writing to support clinical project teams to meet their clinical document deliverables.


The successful candidate will be detailed oriented, self-directed and with the ability to be flexible and manage workload to meet project timelines.


Responsibilities


• Provides Medical Writing leadership for all assets from pre-IND to NDA. • Acts as a medical writing subject matter expert and works with clinical development team to deliver on medical writing program goals. • Oversee, and potentially contribute directly to, the development of a variety of clinical documents for clinical and regulatory purposes, including clinical protocols, clinical study reports, investigator brochures, IND and NDA and other regulatory submissions documents. • Oversee, and potentially contribute directly to, the development of publications/presentations of emerging clinical data for Congresses, and/or other external stakeholders. • Oversee, and potentially contribute directly to, the development of manuscripts summarizing the emerging clinical data. • Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents. • Oversee, or directly contribute to, the planning, process and coordination timelines to ensure timely completion of clinical writing projects. • Manage timelines and communicate with team stake holders to maintain awareness of expectations, milestones, and deliverables. • Provide support for QC of complex clinical documents. • Ensure that the key messages in protocols, publications, presentations and regulatory documents align with each other, and also with the Investor Relations documents. • Ensures that the Medical Writing department is fully resourced to manage the workload for multiple clinical and pre-IND assets. This will include roll-up-yoursleeves personal contribution, bringing in (and supervising) consultants, as well as building an in-house organization.


Qualifications


• Minimum of bachelor’s degree or equivalent in scientific or medical discipline; Advanced degree preferred. • Minimum of 10 years medical writing experience for a pharmaceutical or biotech is required. • Experience supervising other medical writers (whether in an Agency, consultants and/or full-time employees). Experience building teams is preferred. • Deep personal experience in the writing of Protocols, Investigator Brochures, Briefing Documents, and other Regulatory documents. • Additional experience directly contributing to and/or supervising the writing of congress presentations and manuscripts is preferred. • Experienced in resource planning and management experience with virtual teams, employees based in field locations, and functional service providers. • Excellent written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy. • Experience producing high quality clinical and regulatory submission documents.


• Strong project management and organizational skills. • Strong organizational/prioritization skills for the management of multiple concurrent projects. • 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. • Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes


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