Medical Writer I (Remote)

PTC Therapeutics is a global commercial biopharmaceutical company. For over 25 years our team has been deeply committed to a unified purpose: Extending life's moments for children and adults living with a rare disease.

At PTC, we cultivate an inclusive culture where everyone feels valued, respected, and empowered. We welcome candidates from all backgrounds to join our team, fostering a strong sense of belonging.

Visit our website to learn more about our company and culture!
Site: www.ptcbio.com

The Medical Writer I provides technical and operational support to the activities of the scientific writing staff and associated projects. This includes, but is not limited to authoring, editing, and providing input to nonclinical and/or clinical documents, documents required for regulatory submissions to US and other global health authorities, presentations, posters, publications, and regulatory fulfillment.

The incumbent works cross-functionally with internal departments and external resources on Scientific Writing related issues.

The Medical Writer I will collaborate on the development of clinical documents in accordance with all applicable regulations including, but not limited to Good Clinical Practice (GCP), applicable regulatory requirements and guidance documents (e.g., 21 CFR Parts 312 and 314, European Medicines Association [EMA] Clinical Trials Directives, International Congress on Harmonisation [ICH] guidelines) company Standard Operating Procedures (SOPs) and internal style guides, as appropriate.

Responsibilities

• Works with multifunctional teams to prepare documents, which may include nonclinical reports, clinical study reports (CSRs), protocols, protocol amendments, briefing documents, Investigator Brochures (IBs), safety updates, agency responses, and summary modules under strict timelines.
• Supports key regulatory submissions to US and global health authorities (including but not limited to: New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), Investigational New Drug (IND) submissions, and annual reports).
• Ensures key messages are clear and consistent within and across documents.
• Assists with strategic and scientific contributions at the project and/or study team level.
• Provides editorial or review support for other types of documents, such as abstracts, manuscripts, posters, and presentations for scientific meetings and journals as needed.
• Collaborates with cross-functional team members (e.g., PK, Toxicology, Research, Clinical Development, Regulatory Affairs, Biostatistics, Quality, CMC, etc.) to ensure accurate and timely completion/delivery of high-quality, scientifically justified documents.
• Ensures a consistent style of document presentation to maintain quality and ease of review and adherence to company standards.
• Assists in the day-to-day operational activities and other assignments as needed and specified by management.

Qualifications

• Advanced degree in a scientific discipline (PhD, PharmD, or MS) with 0 to 1 year in medical writing experience in pharmaceutical industry OR Bachelor's degree in a scientific discipline with 2+ years of experience at a pharmaceutical or biotechnology company or CRO.
• Up to 10% travel
• Demonstrated ability to communicate and write clearly, concisely, and effectively. Aptitude for compilation, analysis, and presentation of data.
• Basic understanding of biostatistics reporting standards and awareness of the associated biostatistics concepts.
• Attention to detail, including fact checking, logical flow, parallelism, formatting, and document structure.
• Proficiency with Microsoft Office and use of electronic document templates.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Strong planning, organization and time management skills including the ability to support and prioritize multiple projects, and to complete high-quality documents according to tight timelines.

*Special knowledge or skills and/or licenses or certificates preferred.

• Knowledge of the preparation of regulatory submission documents preferred.
• Experience analyzing references for scientific appropriateness and regulatory ramifications of reference selection; familiarity with PubMed and/or other reference-gathering search tools.
• Knowledge of EMA/ICH guidelines and FDA guidance beyond those pertaining to specific regulatory documents.
• Proficiency with Adobe Acrobat, and Electronic Common Technical Document (eCTD) templates.

Expected Base Salary Range:

$ 82,900 - $104,300 USD. The base salary offered will be contingent on assessment of candidate education level, background, and experience relative to the requirements of the position they are being considered for, as well as review of internal equity.

In addition to base salary, PTC employees are also eligible for short- and long-term incentives.All eligible employees may also enroll in PTC's medical, dental, vision, and retirement savings plans.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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