Sr Mgr, Scientific Writing | BioNJ Talent Services

Sr Mgr, Scientific Writing

Contact Information
Contact Name: 
PTC Therapeutics
Organization Name: 
PTC Therapeutics
Position Location: 
South Plainfield
Company Profile: 

PTC is biopharmaceutical company focused on the discovery and development of orally-administered, proprietary small molecule drugs that target post-transcriptional control processes. While PTC’s discovery programs are directed at targets in multiple therapeutic areas, PTC is focusing particularly on the development and commercialization of treatments for orphan and ultra-orphan disorders. Post-transcriptional control processes regulate the rate and timing of protein production and are essential to proper cellular function. PTC’s internally-discovered pipeline addresses multiple therapeutic areas, including neuromuscular disorders, oncology and infectious diseases. For more information on the company, please visit our website www.ptcbio.com. ​

Job Description:

*Job Summary
The Senior Manager, Scientific Writing is responsible for the development and oversight of scientific writing deliverables and is a key member of the Scientific Writing team.

The Senior Manager, Scientific Writing is a lead scientific writer for one or more drug development programs and is accountable for the timely completion, accuracy and quality of all documents. This involves authoring, editing and providing input to clinical documents, documents required for regulatory submissions to US and other global health authorities, presentations, posters, publications and regulatory fulfillment. He/she may also author/edit and/or direct the development of pre-clinical documents.

The Senior Manager, Scientific Writing collaborates 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.

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

Primary duties/responsibilities:

•In adherence with GCP, applicable regulatory requirements and guidance documents (e.g., 21 CFR Parts 312 and 314, EMA Clinical Trials Directives, ICH guidelines) company SOPs and internal style guides, researches, authors, and edits:

•Works with the clinical and regulatory teams to prepare clinical documents including, but not limited to, clinical study reports (CSRs), protocols, protocol amendments, briefing documents, Investigator Brochures (IBs), safety updates, Clinical Summaries of Safety and Efficacy, Clinical Overview, and pre-clinical study protocols and reports under strict timelines.

•Contributes to, and provides oversight for, the completion of major summary submission documents to ensure high-quality submission dossiers.

•May contribute to the planning and completion of key regulatory submissions to US and global health authorities (including but not limited to: New Drug Applications (NDAs), Marketing Authorisation Applications (MAAs), Investigational New Drug (IND) submissions, and annual reports).

•Ensures key messages are clear and consistent within and across documents.

•Contributes scientific knowledge and analytical thinking/skills to Program and Submission Study Team meetings and other cross-functional working groups as needed to facilitate the preparation of reports and the production of registration dossiers.

•Provides editorial or review support for other types of documents, such as abstracts, manuscripts, posters, and presentations for scientific meetings and journals.

•Collaborates with cross-functional team members (e.g., PK, Toxicology, Research, Clinical Development, Regulatory Affairs, Biometrics, 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.

•May provide work direction to contractors/consultants and/or guidance to other scientific writers within PTC.

•Applies knowledge of industry and scientific writing best practices.

•Contributes to process improvement and influences scientific writing strategies within and across functions.

•Assists with day­to­day operational activities and other assignments as needed and specified by management.

Qualifications: 

Education, Experience & Skills:
Minimum level of education and years of relevant work experience.

Advanced degree (PhD or PharmD) in a relevant, scientific discipline and a minimum of 4 years of medical writing experience in a pharmaceutical company or related environment OR a Master’s degree in a scientific discipline and a minimum of 6 years of related experience in a pharmaceutical, biotechnology, CRO or related environment.

Special knowledge or skills needed and/or licenses or certificates required.

•At least 4 years of experience in a medical writing role, including participation in submissions to the US FDA (NDA, BLA) and/or EMA (MAA).

•Demonstrated experience in the preparation of protocols, study reports, investigator brochures, safety updates, and IND clinical sections.

•Demonstrated ability to communicate and write clearly, concisely, and effectively. Aptitude for compilation, analysis, and presentation of data.

•Demonstrated ability to incorporate pre-clinical data into clinical and regulatory documents.

•Excellent understanding of biostatistics reporting standards and awareness of the associated biostatistics concepts.

•Excellent 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.

•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.

•Ability to assist with other regulatory or clinical tasks.

•Broad knowledge of EMA/ICH guidelines and FDA guidance beyond those pertaining to specific regulatory documents.

•Experience analyzing references for scientific appropriateness and regulatory ramifications of reference selection; familiarity with PubMed and/or other reference-gathering search tools.

•Proficiency with Adobe Acrobat, and Electronic Common Technical Document (eCTD) templates.

•Demonstrated project management experience.

* Travel requirements

0-10%

*Physical requirements (only note if the job requires physical capacity beyond general office work)

Office-based position (optionally remote)

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Other