Associate Principal Writer, CMC Technical Writing
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
Job Description Summary:
The Associate Principal Writer for CMC Technical Writing at PTC Therapeutics (PTC) provides CMC technical knowledge and expertise for Chemistry, Manufacturing, and Control (CMC) regulatory document submissions to global health authorities. Responsibilities include (but are not limited to) authoring, editing, content verification, and providing input to CMC-related documents required for regulatory submissions. The incumbent will collaborate closely with Regulatory CMC Leads, as well as cross-functionally with PTC internal departments and external partners, on CMC technical writing related issues. Additionally, the Associate Principal Writer of CMC Technical Writing will contribute to the development of CMC-related documents in accordance with all applicable regulations including (but not limited to) current Good Manufacturing Practices (cGMPs), applicable regulatory guidance documents (e.g., 21 CFR Parts 312 and 314, European Medicines Association [EMA] Clinical Trials Directives, International Congress on Harmonisation [ICH] guidelines), and company Standard Operating Procedures (SOPs) and internal style guides, as appropriate.Job Description:
Responsibilities:
- Leads analysis and interpretation of CMC-related technical data (from SOPs, Batch Records, Reports, etc.) to author CMC dossier content for clinical trial applications (e.g., IND/IMPDs), marketing applications (e.g., NDA/BLA/MAAs), and other documents needed to support regulatory interactions and health authority filings for small molecules and/or biologics.
- Performs editorial review of documents prepared by other team members for completeness, accuracy, consistency, structure, and grammar.
- Coordinates authoring and review activities with Regulatory CMC leads, Pharmaceutical Development/Technical Operations, and Quality Assurance Teams to reach regulatory alignment and to meet deadlines for health authority submissions.
- Participates in key cross-functional meetings to align on general strategy for content and authoring of documents.
- Works closely with Global Regulatory Affairs (GRA) to establish priorities and ensure successful completion of CMC-related authoring activities, including timely handover of intended submission content to the Regulatory Operations Team.
- Ensures key persuasive messaging is clear and consistent within and across documents.
- Ensures consistent document presentation style to maintain quality, ease of review, and adherence to company standards.
- Exhibits required attention to detail, including fact checking, logic flow, parallelism, formatting, and document structure.
- Contributes to the development and standardization of templates and submission related processes.
- As needed, assists in day-to-day operational activities and other assignments specified by management.
Qualifications:
Advanced degree (PhD, PharmD, or MS) with 5+ years in pharma/biotech industry with at least 3 years for regulatory CMC writing experience in pharmaceutical industry OR Bachelor’s degree in a scientific discipline with 7+ years of experience in a pharmaceutical, biotechnology, or CROs.
- Demonstrated experience in a CMC writing role, including participation in investigational, initial and/or post-approval submissions to the US FDA (IND, NDA, BLA) and/or EMA (IMPD, MAA).
- Broad knowledge of ICH, EMA, and FDA guidance beyond those pertaining to specific regulatory documents.
- Excellent attention to detail, including fact checking, logic flow, parallelism, formatting, and document structure.
- Ability to influence without direct authority.
- Proficiency with Microsoft Office and use of electronic document templates.
- Excellent verbal and written communication skills.
- Demonstrated experience with Electronic Document Management Systems (EDMS) for managing the authoring, review, and approval of regulatory documents.
- 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.
- Excellent 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 EMA/ICH guidelines and FDA guidance beyond those pertaining to specific regulatory documents.
- Proficiency with Adobe Acrobat and Electronic Common Technical Document (eCTD) templates.
- Demonstrated project and/or people management experience.
Travel requirements: Approximately 10%
Expected Base Salary Range:
$121,600 – $153,000. 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.
Click here to return to the careers page
Originally posted on Himalayas
Apply To this Job