Associate Director, Medical Writing

Supernus Pharmaceuticals Inc; Rockville (MD); On-site; USD 166,000 - 193,000; Full time

Benefits offered by this job

Stock equity awards

Employee stock purchase program

Health and wellness benefits

401k company match

Life insurance

Job summary

Supernus Pharmaceuticals Inc seeks an Associate Director of Medical Writing to lead multiple programs and provide strategic oversight of clinical and regulatory documents. You will guide matrixed teams, plan timelines, and develop content for NDA/BLA/IND submissions in accordance with company guidelines.

You will advise study teams on regulatory requirements, coordinate content across programs, and partner with contractors to deliver high-quality submissions while mitigating risks and ensuring

Qualifications

• Bachelor’s or Master’s degree in science with years of medical writing experience.
• PhD is highly desirable with relevant work experience in pharma/CROs.
• Experience leading medical writing and project management teams.
• Experience in clinical regulatory writing in pharma or CRO space.
• Ability to lead and manage people across teams.

Responsibilities

• Plan, lead, and author documents for regulatory filings.
• Provide SME guidance on scope, content, and study data.
• Coordinate with internal teams and outside contractors.
• Review and ensure accuracy and alignment with regulatory position.
• Develop goals and initiatives for the medical writing department.

Skills

Medical writing

Regulatory writing

Leadership

Team collaboration

Project management

Education

Bachelor's in physical or life science

Master's degree

PhD desirable

Tools

Veeva Vault

Microsoft Office

Job description

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 Associate Director of Medical Writing will provide leadership and functional oversight for multiple programs reporting to the Head of Medical Writing. This role will independently plan, lead, provide guidance to matrixed stakeholder team, and develop content for clinical and regulatory documents in accordance with company guidelines to support regulatory filings.

• 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.
• Other responsibilities and projects assigned.

Supervisory Responsibilities:

• Provides leadership and management in an effective manner consistent with Company Values towards defined Corporate Objectives.
• Understands Company Policy and procedure to be able to guide direct reports appropriately.

Knowledge & Other Qualifications:

• Bachelor’s in physical or life science required with a minimum of 8+ years of experience or a Master’s degree with a minimum 6+ years of relevant medical writing and project management experience.
• PhD degree is highly desirable with a minimum of 5+ years relevant work experience in pharmaceutical companies or CROs.
• Experience in clinical research or medical/clinical writing, in a pharmaceutical or CRO is preferred.
• Demonstrated direct clinical regulatory writing experience in a pharmaceutical, biotech, or CRO space.
• 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 relevant regulatory guidance especially ICH E6 and E3.

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 $166,000 to $193,000. 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.

Equal Opportunity Employer

This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.