What are the responsibilities and job description for the Associate Director, Medical Writing position at Stoke Therapeutics?
About Stoke:
Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to addressing the underlying cause of severe diseases. The company is pursuing an entirely new approach to treating severe diseases. We are initially focused on diseases of the central nervous system and the eye, with an emphasis on haploinsufficiencies, which are diseases caused by a loss of about half of the normal protein levels. Rather than replace, repair or edit faulty genes, we aim to increase – or stoke – protein output from healthy genes to restore functional protein levels using our proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) platform. In all, Stoke has identified ~6500 genes with a TANGO signature, representing broad potential for our approach to help people with severe diseases.
We recently announced landmark data that support the potential for STK-001 to be the first disease-modifying medicine for Dravet syndrome, a severe and progressive genetic epilepsy that is characterized by frequent, prolonged and refractory seizures, beginning within the first year of life. The disease is classified as a developmental and epileptic encephalopathy due to the developmental delays and cognitive impairment associated with the disease.
Stoke is also advancing STK-002, a potential treatment for autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. Currently there are no approved treatments for ADOA. Clinical studies of STK-002 are anticipated to start in 2024. The company is pursuing potential new medicines for three additional neurodevelopmental disorders, including Syngap1 and Rett syndrome, in collaboration with Acadia Pharmaceuticals.
Position Purpose:
The Associate Director, Medical Writing will prepare, author, and complete regulatory documents necessary to ultimately support submissions to global health authorities. The Medical Writer (MW), positioned in Regulatory Affairs, will closely partner with Clinical, Nonclinical, Pharmacovigilance, CMC, and DMPK to support the authoring of regulatory documents and meeting packages. The MW will work directly with key product team members to communicate and drive timelines, lead document review, and roundtable discussions. This position will report to the Senior Director, Medical Writing.
Key Responsibilities:
Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is a hybrid position with an office setting based in our Bedford, MA location.
Travel:
This position will require approximately 5% travel.
Culture & Values:
At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual’s needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.
Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging Committee (DIB) underscores the importance of DIB to who we are and what we do.
Benefits & Compensation:
At Stoke Therapeutics we are proud to offer comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Parental Leave; a 401K program with company match, unlimited vacation time, and an Employee Stock Purchase Program (ESPP). Compensation is market competitive for the industry and directly commensurate with experience. All positions are bonus and stock eligible.
Interested candidates: Please visit Stoke’s website to learn more and apply directly to the position listed on our Career Center:
https://www.stoketherapeutics.com/careers/
For more information, visit https://www.stoketherapeutics.com/ or follow the company on Twitter at @StokeTx.
All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status.
Stoke participates in E-Verify.
Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to addressing the underlying cause of severe diseases. The company is pursuing an entirely new approach to treating severe diseases. We are initially focused on diseases of the central nervous system and the eye, with an emphasis on haploinsufficiencies, which are diseases caused by a loss of about half of the normal protein levels. Rather than replace, repair or edit faulty genes, we aim to increase – or stoke – protein output from healthy genes to restore functional protein levels using our proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) platform. In all, Stoke has identified ~6500 genes with a TANGO signature, representing broad potential for our approach to help people with severe diseases.
We recently announced landmark data that support the potential for STK-001 to be the first disease-modifying medicine for Dravet syndrome, a severe and progressive genetic epilepsy that is characterized by frequent, prolonged and refractory seizures, beginning within the first year of life. The disease is classified as a developmental and epileptic encephalopathy due to the developmental delays and cognitive impairment associated with the disease.
Stoke is also advancing STK-002, a potential treatment for autosomal dominant optic atrophy (ADOA), the most common inherited optic nerve disorder. Currently there are no approved treatments for ADOA. Clinical studies of STK-002 are anticipated to start in 2024. The company is pursuing potential new medicines for three additional neurodevelopmental disorders, including Syngap1 and Rett syndrome, in collaboration with Acadia Pharmaceuticals.
Position Purpose:
The Associate Director, Medical Writing will prepare, author, and complete regulatory documents necessary to ultimately support submissions to global health authorities. The Medical Writer (MW), positioned in Regulatory Affairs, will closely partner with Clinical, Nonclinical, Pharmacovigilance, CMC, and DMPK to support the authoring of regulatory documents and meeting packages. The MW will work directly with key product team members to communicate and drive timelines, lead document review, and roundtable discussions. This position will report to the Senior Director, Medical Writing.
Key Responsibilities:
- Collaborate cross-functionally to prepare ICH-compliant documentation including, but not limited to, clinical trial protocol synopses, protocols, protocol amendments, lay summaries, clinical study reports, Investigator Brochures, eCTD Module 2 summaries, briefing packages, regulatory responses, and other documents as necessary.
- Assist with planning and overall project management of document timelines.
- Oversee the data verification or quality review process for documents.
- Interface with the document publishing to facilitate publishing of documents in an efficient hand-off to the regulatory submissions team.
- Partner with Clinical Operations, Nonclinical, Program Management, Pharmacovigilance, CMC, and Regulatory Affairs teams to deliver and drive the timely completion of activities related to clinical-stage programs.
- Responsible for ensuring use of editorial standards and style guides.
- Oversee formatting of documents, ensure a consistent presentation to maintain quality and ease of review.
- Ensure compliance with SOPs, ICH guidelines, GCP guidelines, EU-CTR, and regulatory requirements.
- Assist in the development of SOPs and style guides to improve the overall regulatory authoring business process.
- Other duties and responsibilities, as required.
- Bachelor's degree required; advanced degree preferred.
- 8 years’ experience in a medical writing capacity within the pharmaceutical/biotechnology environment.
- Proficient in utilizing the StartingPoint templates and document management systems, such as Veeva RIM.
- Detailed knowledge of the requirements for the preparation of key clinical, nonclinical and regulatory documents for INDs, CTAs, NDA/BLA/MAA.
- Working knowledge of drug development, clinical research, study design, biostatistics, regulatory, and medical terminology.
- Understanding of ICH and GCP guidelines, FDA regulations, EU-CTR, and other relevant regulatory standards governing regulatory documentation.
- Proficient in organizing and interpreting complex scientific and clinical data.
- Experience in neurology and/or the rare disease space strongly preferred.
- Ability to work collaboratively in a cross-functional team environment and to manage multiple projects and priorities.
- Proficiency with Microsoft Office and eCTD-compliant formatting and editing templates (eg, StartingPoint) and document management systems (eg, Veeva RIM).
- Experience managing documentation within a Part 11 compliant documentation management system.
- Ability to work independently and collaboratively, as required, in a fast-paced start-up 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.
- Excellent verbal and written communication skills.
Stoke operates sites in Bedford, MA, and Cambridge, MA. This position is a hybrid position with an office setting based in our Bedford, MA location.
Travel:
This position will require approximately 5% travel.
Culture & Values:
At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically. We allow for flexibility in work arrangements that balance individual’s needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.
Our values guide our work to deliver meaningful medicines for people who need them. We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us. We embrace diversity within a unique culture that is defined by our values. Our employee-led Diversity, Inclusion, and Belonging Committee (DIB) underscores the importance of DIB to who we are and what we do.
Benefits & Compensation:
At Stoke Therapeutics we are proud to offer comprehensive and competitive employee benefits, including medical, dental and vision insurance; life, long and short-term disability insurance; Paid Parental Leave; a 401K program with company match, unlimited vacation time, and an Employee Stock Purchase Program (ESPP). Compensation is market competitive for the industry and directly commensurate with experience. All positions are bonus and stock eligible.
Interested candidates: Please visit Stoke’s website to learn more and apply directly to the position listed on our Career Center:
https://www.stoketherapeutics.com/careers/
For more information, visit https://www.stoketherapeutics.com/ or follow the company on Twitter at @StokeTx.
All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status.
Stoke participates in E-Verify.
