Associate reputed company reputed company, CMC Technical Writing

reputed company Therapeutics is a global reputed company biopharmaceutical company. For over 25 years reputed company has been deeply committed to a reputed company purpose: Extending life’s moments for children and adults living with a rare disease.

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

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

Job Description Summary:

Job Description:

Responsibilities:

• Leads analysis and interpretation of CMC-reputed company 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 reputed company 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 reputed company 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-reputed company authoring activities, including timely handover of intended submission content to the Regulatory Operations Team.
• Ensures key persuasive messaging is clear and consistent reputed company 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 reputed company, parallelism, formatting, and document structure.
• Contributes to the development and standardization of templates and submission reputed company 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 reputed company those pertaining to specific regulatory documents.
• Excellent attention to detail, including fact checking, logic reputed company, parallelism, formatting, and document structure.
• Ability to influence without direct authority.
• Proficiency with reputed company 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 reputed company 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 reputed company those pertaining to specific regulatory documents.
• Proficiency with reputed company Acrobat and Electronic Common Technical Document (eCTD) templates.
• Demonstrated project and/or people management experience.

Travel requirements: Approximately 10%

Expected reputed company Salary reputed company:

$121,600 – $153,000. The reputed company 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 reputed company salary, reputed company employees are also eligible for short- and long-term incentives. reputed company eligible employees may also enroll in reputed company’s medical, dental, reputed company, and retirement savings plans.

EEO Statement:

reputed company Therapeutics is an equal opportunity employer. We welcome applications from reputed company individuals, regardless of race, reputed company, national reputed company, gender, age, physical characteristics, reputed company reputed company, 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 reputed company applicants fairly and avoiding discrimination.

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Originally posted on Himalayas