Job Summary

Become part of our mission to improve the lives of patients suffering from CNS diseases today. We are looking for an enthusiastic, highly motivated, and experienced Associate Director to join our Medical Writing (MW), Clinical Research department at Supernus Pharmaceuticals.

We are an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat CNS disorders.

This position is for a mid-senior level medical writer who will provide leadership and functional oversight for multiple programs reporting to the Senior Director, MW. This role will independently plan, lead, provide guidance to matrix stakeholder team, and develop content for clinical and regulatory documents as per company guidelines to support regulatory filings. Individuals must have demonstrated direct clinical regulatory writing experience in a pharmaceutical, biotech, or CRO space.

Essential Duties & Responsibilities:

• Provides strategic input into program-level plans for document development and authoring, deliverable level timelines to meet program-level goals and objectives
• Provides leadership and guidance at the team level as an SME for document scope and content
• Contributes strategically and scientifically at the study team level with recommendations for data reviews, collection of specific data, data outputs, and document content
• Proactively advice study and submission teams regarding regulatory requirements and ICH guidance for clinical documents
• Aligns, coordinates, and builds consistent information and messages across clinical program(s) for deliverables
• Independently plans, manages, and authors routine and complex documents in support of the clinical development program and submissions including (but not limited to) the following:
• Clinical synopsis and protocols
• Clinical study reports
• Investigator brochures
• Annual Safety Reports
• Abstracts and manuscripts
• Documents for NDA, BLA, IND, CTA, SOPs etc
• Reviews and provides oversight of documents prepared by outside contractors for content, clarity, accuracy, consistency, and alignment with company's position.
• Proactively anticipates risks, provides solutions, and takes necessary actions to mitigate risks, manages expectations of stakeholders
• Participates in developing and implementing goals and initiatives for the MW department
• Facilitates implementation of new technologies and initiatives at the enterprise level related to the preparation of clinical regulatory documents

Non-Essential Duties & Responsibilities:

• N/A

Supervisory Responsibilities: Yes

• The individual may manage more junior medical writers in the Clinical Research Department.

Knowledge and Other Qualifications:

• Bachelor's Degree or Master's in physical or life science required with minimum 6+ years of relevant medical writing and project management experience (prefer clinical research/medical and clinical writing) in pharmaceutical companies or CROs
• PhD degree is highly desirable with Minimum of 5+ years relevant work experience (prefer clinical research/medical and clinical writing) in pharmaceutical companies or CROs
• Demonstrated experience in being able to lead, collaborate, and manage people
• Strong understanding of Microsoft Office
• Experience in Veeva Vault document management
• 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
• Demonstrated aptitude in planning, managing, and optimizing department resources to maximize and streamline process to meet company goals and objectives
• 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