Senior Manager, Medical Writing

Supernus Pharmaceuticals is an award-winning biopharmaceutical company with more than 30 years of experience in developing and commercializing products that treat central nervous system (CNS) diseases. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. At Supernus, we develop innovative products that help treat neurological and psychiatric conditions. We currently have 8 products in the market that are making a real impact on patient outcomes.

Job Summary:

The Senior Manager, Medical Writing, is responsible for presenting clinical data objectively in a clear, concise format, and will independently plan, lead, provide guidance to matrix stakeholder team, and develop content for clinical and regulatory documents.

Essential Duties & Responsibilities:

• 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

• Contributes strategically and scientifically at the study team level with recommendations for data reviews, collection of specific data, data outputs, and document content.

• Works effectively with company document management system and related tools, templates, and procedures in order to ensure efficient production and publishing of documents.

• Ensures a consistent style of presentation of documents to maintain quality and ease of review.

• Aligns, coordinates, and builds consistent information and messages across clinical program(s) for deliverables.

• Reviews and provides oversight of documents prepared by outside contractors for content, clarity, accuracy, consistency, and alignment with company's position.

• 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.

• Other responsibilities and projects as assigned.

Supervisory Responsibilities:

• N/A.

Knowledge & Other Qualifications:

• Master's degree in a physical or life science discipline required, with a minimum of 5 years of relevant work experience in pharmaceutical or Clinical Research Organizations. Will consider other relevant Medical Writing experience in similar industries.
• PhD degree is highly desirable with Minimum of 3 years relevant work experience in pharmaceutical or Clinical Research Organizations. in pharmaceutical companies or CROs.
• Experience in clinical research or medical/clinical writing is preferred.
• Familiarity with the relevant regulatory guidance, especially ICH E6 and E3.
• Strong understanding of Microsoft Office.
• Experience in Veeva Vault document management.
• Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.
• Ability to work both independently and collaboratively with a team.
• Experience in successfully resolving conflicting editorial opinions expressed by team members.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
• Possesses strong written and verbal communication skills

Other Characteristics:

• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• Ability of having an innovative and dynamic approach to work.
• A self-starter able to work independently but comfortable working in a team environment.
• Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.
• Capable of performing other duties as assigned by Management.
• Authorized to legally work in the United States without visa sponsorship.

Physical Requirements/Work Environment/Travel Requirements:

• 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.

Compensation:

At Supernus, we offer a competitive compensation package that reflects your experiences and contributions. The expected salary range for fully qualified candidates applying for this role is $140,000 to $175,000. This range is what the Company reasonably expects to offer for the position and is not reflective of the full compensation scale of the role. This range may be modified in the future. An individual's salary within the range is based on multiple factors, which may include and are not limited to education, relevant experience, knowledge, length of industry experience and organizational needs.

You also will be able to participate in a competitive benefits package, including but not limited to: health, dental, vision, paid time off, 401k company match, company paid life insurance and health and wellness benefits. The total compensation package for this position also includes other compensation elements such as stock equity awards, employee stock purchase programs and participation in our Company's discretionary annual bonus program.

Supernus Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, national origin, disability, protected veteran status, age or any other characteristic protected by law.