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Director, Clinical Research, Medical Writing

Rockville, MD
  • Expired: October 13, 2020. Applications are no longer accepted.

Job Summary This position will lead and manage the Medical Writing group within Clinical Research. Individual will be responsible for preparation of Clinical Documentation in support of Phase 1-4 clinical studies. Position will require professional writing as well as review of other documents prepared by outside contractors.

The individual will also be responsible for the Clinical Sections of regulatory documents. Essential Duties & Responsibilities: * Creation and/or review of technical documents in support of clinical development including (but not be limited to) the following: * Clinical synopsis and protocols * Clinical study reports * Investigator brochures * Annual Safety Reports * Abstracts and manuscripts * NDA, BLA, IND, CTA etc * Creation and review of clinical documents related to regulatory filing including clinical sections of IND's and NDA's. * Creation and review of all regulatory packages that are usually submitted to regulatory authorities prior to meetings. * Creation and review of study data presentations in various formats (platform presentations, abstracts, posters, publications). * Researches, writes and edits clinical reports. * Generation of SOPs and implement processes for efficiency Non-Essential Duties & Responsibilities: * N/A Supervisory Responsibilities: Yes * The individual will manage the Medical Writing group in the Clinical Research Department. Knowledge and Other Qualifications: * Bachelor's Degree or Master's in physical or life science required with 10+ years of relevant work experience (prefer clinical research/medical and clinical writing) in pharmaceutical companies or CROs * PhD degree is highly desirable with Minimum of 6+ years relevant work experience (prefer clinical research/medical and clinical writing) in pharmaceutical companies or CROs * Demonstrated experience in being able to lead and manage people * Strong understanding of Microsoft Office * Working knowledge of medical terminology * Familiarity with the relevant regulatory guidance especially ICH E6 and E3 Other Characteristics: * Self-starter with a proven ability to work with minimal supervision * Ability to work independently and as part of a team * Resourceful and innovative in approach to work. Able to learn quickly and multi-task * Ability to work well under pressure, meet deadlines and deliver on commitments * Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others * Ability to maintain high ethical standards of integrity and quality * Authorized to legally work in the United States without visa sponsorship Physical Requirements / Work Environment * Sedentary work. Exerting up to 10 pounds of force occasionally and/or carrying objects.

Sedentary work involves sitting most of the time. * The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer screen, iPad, or other electronic device; and extensive reading * The worker is not substantially exposed to adverse environmental conditions Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law. #CB



Rockville, MD
20850 USA



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