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Harmony Biosciences Holding, Inc. Senior Director, Medical Writing in Plymouth Meeting, Pennsylvania

Reference #: 1420

Harmony Biosciences is recruiting for a Senior Director, Medical Writing. In this role, you will be accountable for the timely preparation of high-quality regulatory documents supporting the clinical development portfolio at Harmony. This includes, but is not limited to, authoring, editing, and providing project management support for clinical regulatory documents including protocols, amendments, investigator's brochures, and clinical study reports, as well as various other clinical and non-clinical documents.

Responsibilities include but are not limited to:

1. Manage all aspects of the preparation of regulatory documents for submission to global regulatory authorities in accordance with ICH and other global guidelines, standards and processes, and AMA Medical Writing styles, as applicable, in adherence with study/project timelines and corporate objectives.
2. Manage EU regulatory submissions in collaboration with appropriate external resources.
3. Manage contract medical writing resources as required to ensure timely completion of assigned projects.
4. Actively participate in study and/or project team meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
5. Develop and implement process standards.
6. Review, edit, and ensure quality of documents prepared by other functional area representatives (such as Biostatistics and Clinical Operations) to ensure adherence to standards and global regulatory guidance and requirements.
7. Write, review, and/or edit clinical trial registry postings.
8. Manage transparency/disclosure vendors.
9. Set standard of excellence for self and others.
10. Perform other duties as assigned.

Qualifications:

1. Bachelor's degree required, preferably within a life science discipline.
2. 10+ years medical writing experience required within the biopharmaceutical / CRO industry.
3. Proficient knowledge of global regulatory requirements.
4. Strong organizational, time management, leadership, and project management skills.
5. Proficiency in MS Word and template systems (e.g., StartingPoint).
6. Strong verbal, written, and interpersonal communication skills.
7. High ethical & quality standards lived through actions and communication.
8. Demonstrated ability to function independently with minimal guidance while simultaneously covering multiple project responsibilities in a fast-paced environment.

Physical demands and work environment: While performing the duties of this job, the noise level in the work environment is usually quiet.

What can Harmony offer you?

1. Medical, Vision and Dental benefits the first of the month following start date.
2. Generous paid time off and Company designated Holidays.
3. Company paid Disability benefits and Life Insurance coverage.
4. 401(k) Retirement Savings Plan.
5. Paid Parental leave.
6. Employee Stock Purchase Plan (ESPP).
7. Company sponsored wellness programs.
8. Professional development initiatives and continuous learning opportunities.
9. A certified Great Place to Work for seven consecutive years based on our positive, values-based company culture.

Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit www.harmonybiosciences.com.

Harmony Biosciences is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.