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Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of...\n","descriptionText","Regulatory Affairs Associate Hire Talent Creative & Design Job Title Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of...","shortDescription","Job Title

Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for ...","location","locations",[451],{"_452":453,"_454":455,"_456":457,"_458":459,"_460":461},"formatted","Lake Forest, IL, United States, 60045","city","Lake Forest","state","IL","country","United States","postal_code","60045","companyName","Hire Talent","salaryMin","salaryMax","salaryDescription","https://us.thebigjobsite.com/redirectfeedjob?jobid=2FD0336114C8D1377DE9FDEC361B5EF4&source=mediabistroxmlus&utm_source=mediabistroxmlus&jobSiteKey=AAFC50C3076719AB6FF5EB56C92079A3","companyDescription","companyWebsite","displayLogo","https://www.mediabistro.com/public/images/desk-100x50.webp","displayThumbnail","displayHeadline","Work at Hire Talent","isManualPosted","costPerClick",0.12,"displayUrl","fullUrl","https://www.mediabistro.com/jobs/3077329801-regulatory-affairs-associate","strippedDescription","Job TitleResponsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval. Authoring and submitting PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports). Review/approval of engineering study protocols/reports and validation study protocols/reports. Review and approval of...\n","parsedLocation",{"_452":485,"_486":199,"_487":199,"_454":455,"_456":457,"_458":459,"_460":461},"Lake Forest, IL, United States","street1","street2","displayPublishedAt","7 hours ago","shortTitle","shortLocation","level","searchCompanyPath","/jobs?keyword=Hire+Talent","searchLocationPath","/jobs?location=Lake+Forest%2C+IL%2C+United+States","searchTitlePath","/jobs?keyword=Regulatory+Affairs+Associate","featuredCompany",{"_431":501,"_15":502,"_503":434,"_76":504,"_505":506,"_248":507,"_448":508,"_509":-5,"_510":-5,"_511":-5,"_512":513,"_514":515,"_516":517,"_470":504,"_478":518,"_472":519},8752,"Newsday Media Group","agency","https://production-rails-default.s3.us-east-2.amazonaws.com/public/legacy-logos/351727.GIF","slug","newsday-media-group","

Newsday Media Group is a locally owned, independent media company grounded in journalistic excellence, integrity, and commitment to the communities it serves. With 19 Pulitzer Prizes and dozens of Emmy Awards, it's one of the most decorated news organizations in the country.

The company is in the middle of a significant transformation, expanding from its newspaper roots into a multimedia operation spanning digital, video, podcasts, live events, and data-driven civic engagement. NMG properties include the flagship Newsday and Newsday.com, NewsdayTV, the Newsday Live events series, and nextLI, a civic research and community forum platform funded by The Rauch Foundation.

A new 130,000-square-foot headquarters in Melville features a broadcast-quality TV studio and multimedia production space. Newsday Live produces a growing calendar of food and wine tastings, author talks, sports Q&As, concerts, and community events. Feed Me, the company's food and dining vertical, includes a web series, quarterly print magazine, and restaurant coverage. Brand 360, the in-house content studio, partners with advertisers across healthcare, education, energy, tourism, and retail.

Newsday's investigative unit has driven real-world change, from prompting schools to replace unsafe football helmets to contributing reporting that led to federal corruption convictions. Community programs include the Newsday Marching Band Festival, CheerFest, Scholar-Artist honors, and partnerships with local nonprofits focused on hunger, housing, youth education, and child welfare.

For people who care about local journalism, multimedia storytelling, and community impact, Newsday is doing the work at scale.

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Key Responsibilities

Management of overall study planning, study execution, and delivery of multiple global clinical programs. Including but not limited to oversight of and accountability for the collection of high‑quality clinical data.
Oversee review and interpretation of efficacy and safety data. Contribution to clinical trial safety oversight by participating in safety review and analysis of clinical trial data consistent with Safety Review Plan.
Close collaboration with Clinical Operations, Toxicology/Pharmacology, Preclinical, Regulatory, Biostatistics, and outside contractors to ensure the successful strategic integration of clinical development plans and strategies.
Contribute to authoring, review, and approval of required clinical study protocols, clinical study reports (CSRs), sections of regulatory documents such as Investigators’ Brochures, briefing books, safety updates, IND/CTA submission documents, and responses to Health Authorities’ questions.
Collaboration with CMC/clinical suppliers to provide clinical trial supply assumptions and contribution to design and packaging of supplies for clinical trials.
Communication with internal and external teams in a high impact, highly visible fashion through written and verbal means.

Qualifications

PhD, PharmD, or MD
Minimum 10+ years of biopharmaceutical industry drug development experience, early through late‑stage development, including the design and conduct of early and late phase clinical studies. CNS/Neuroscience experience strongly preferred.
Proven ability to lead a multidisciplinary team toward a successful outcome.
Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple geographic regions.
Excellent strategic and project management skillset with drug development programs
Ability to work with the Senior Management Team and other external audiences such KOLs and regulatory bodies.
Ability to thrive in highly entrepreneurial biotech environment, with some prior experience in a small/medium size company an advantage.
“Hands‑on”, “roll‑up‑the‑sleeves” when necessary, leader who understands the need for involvement in a small company environment while recognizing when to delegate and seek results from the team.
Thorough understanding of country‑specific, FDA (and equivalent), ICH and GCP guidelines as well as cross‑functional clinical processes including data management, pharmacovigilance, biostatistics, medical writing, and study reporting.
Excellent interpersonal, communication, negotiation and influencing skills.
Experience having managed significant accelerations and challenges in clinical programs is desirable.
Ability to travel domestically and international (up to 10% of the time)

#J-18808-Ljbffr","

Key Responsibilities

Management of overall study planning, study execution, and delivery of multiple global clinical programs. ...","Head of Medical Science (Boston, MA)",[531],{"_458":459,"_454":532,"_452":533,"_456":534,"_460":535},"Boston","Boston, MA, United States, 02298","MA","02298",["B","2282174299"],"Work at Cedent","28 days ago","/jobs/2282174299-head-of-medical-science-boston-ma","Boston, MA, United States","/jobs?keyword=Cedent","/jobs?location=Boston%2C+MA%2C+United+States","/jobs?keyword=Head+of+Medical+Science+%28Boston%2C+MA%29",{"_435":434,"_439":545,"_470":471,"_462":546,"_248":547,"_446":548,"_433":434,"_113":442,"_437":199,"_438":199,"_472":471,"_448":199,"_449":549,"_431":555,"_473":556,"_436":117,"_488":557,"_478":558,"_490":442,"_491":559,"_493":560,"_495":561,"_497":498},["D",1774785600000],"Abbott","Title:

Regulatory Affairs Associate\nLocation:

Santa Clara, CA\nDuration:

12Months\n100% Onsite\nSummary:\nWe are looking for an experienced Regulatory Affairs professional to manage regulatory submissions and approvals for medical devices, including high-risk (Class III) implantable products. The candidate will be responsible for preparing and submitting regulatory documents and ensuring compliance with regulatory requirements.\nKey Responsibilities:\nPrepare and submit PMA applications, supplements, and annual reports\nHandle communication with regulatory authorities such as the FDA\nReview and approve engineering and validation reports\nEvaluate and approve manufacturing and design changes\nEnsure compliance with regulatory guidelines and standards\nSupport cross-functional teams during product development and approval\nMaintain accurate regulatory documentation\nRequirements:\nBachelor’s or Master’s degree in Life Sciences, Engineering, or related field\n5–8 years of experience in Regulatory Affairs (medical devices)\nExperience with PMA submissions and Class III medical devices\nStrong knowledge of FDA regulations and compliance requirements\nGood communication and documentation skills.\nConsultants Eligible Benefits Upon Waiting Period:\nMedical and Prescription Drug Plans\nDental Plan\nVision Plan\nHealth Savings Account (for High-Deductible Health Plans)\nFlexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)\nSupplemental Life Insurance\nShort Term Disability (coverage varies by state)\nLong Term Disability\nCritical Illness, Hospital coverage, Accident Insurance\nMetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance\n401(k)\nAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.\nWorking together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.

#J-18808-Ljbffr\n","Title:

Regulatory Affairs Associate\nLocation:

Santa Clara, CA\nDuration:

12Months\n100% Onsite\nSummary:\nWe are looking for...",[550],{"_458":459,"_454":551,"_452":552,"_456":553,"_460":554},"Santa Clara","Santa Clara, CA, United States, 95053","CA","95053",["B","3056361585"],"Work at Abbott","1 days ago","/jobs/3056361585-regulatory-affairs-associate","Santa Clara, CA, United States","/jobs?keyword=Abbott","/jobs?location=Santa+Clara%2C+CA%2C+United+States",{"_435":434,"_439":563,"_470":471,"_462":564,"_248":565,"_446":566,"_433":434,"_113":567,"_437":199,"_438":199,"_472":471,"_448":199,"_449":568,"_431":574,"_473":575,"_436":132,"_488":576,"_478":577,"_490":567,"_491":578,"_493":579,"_495":580,"_497":581},["D",1774923382000],"Aequor Technologies","*PIPELINE*
TITLE: Medical Writer
Must have 5 -7 years of experience.

POSITION SUMMARY:
The Medical Writer a ccountable for the timely delivery of high quality, regulatory-compliant documents including but not limited to protocols, IBs, clinical study reports, health authority briefing books and clinical summary documents for assigned program and ensures documents are delivered per corporate objectives, from planning through internal approval.

Responsibilities and Duties:
- Responsible for the development of high quality clinical documents submitted to Regulatory Authorities (e.g. FDA and EMA) including Clinical Study Reports, Investigator Brochures, Protocols, Protocol Amendments, Briefing Documents, Health Authority responses, and clinical summary sections of Common Technical Documents (CTDs) in support of worldwide regulatory submissions.
- Collaborates with Global Development Teams and Clinical Development to ensure alignment with program objectives.
- Oversees and reviews medical writing deliverables assigned to contractors or other third party vendors.
- Participates in Global Medical Writing initiatives on clinical development cross-functional teams.
- Assists with development and implementation of Medical Writing processes improvement in line with SOPs.
- Owns and updates assigned Medical Writing SOPs, as necessary.
Educational Requirements:
- Bachelor's Degree in life science, health-related or pharmaceutical field, or the equivalent in experience. Advanced degree preferred.
Experience:
- Minimum of 5 years combined experience in academic/clinical and/or industry setting writing clinical protocols, CSRs and/or medical and/or scientific documents.
- Previous experience in Medical Writing in clinical drug development.
- Familiarity with the regulatory submission process, ICH and GCP guidelines and recommendations.
- Knowledge of template development, document management systems and requirements.
- Strong working knowledge of Medical Writing requirements and document components.
- Good interpersonal skills that involves working well in a team environment and the ability to lead others.
- Strong PC skills including Medical Writing software, Windows and MS Office products specifically Word, Excel, MS Project, and PowerPoint (and any additional software packages utilized ).
","*PIPELINE*
TITLE: Medical Writer
Must have 5 -7 years of experience.

POSITION SUMMARY: <...","Aequor Technologies is hiring: Medical Writer in Princeton",[569],{"_458":459,"_454":570,"_452":571,"_456":572,"_460":573},"Princeton","Princeton, NJ, United States, 08543","NJ","08543",["B","1531197538"],"Work at Aequor Technologies","2 hours ago","/jobs/1531197538-aequor-technologies-is-hiring-medical-writer-in-princeton","Princeton, NJ, United States","/jobs?keyword=Aequor+Technologies","/jobs?location=Princeton%2C+NJ%2C+United+States","/jobs?keyword=Aequor+Technologies+is+hiring%3A+Medical+Writer+in+Princeton",{"_435":434,"_439":583,"_470":471,"_462":584,"_248":585,"_446":586,"_433":434,"_113":587,"_437":199,"_438":199,"_472":471,"_448":199,"_449":588,"_431":592,"_473":593,"_436":117,"_488":538,"_478":594,"_490":587,"_491":595,"_493":596,"_495":597,"_497":598},["D",1772510030000],"OSI","
The Director, Biostatistics will work in collaboration with the Head of Biometrics to provide strong statistical support to advance PepGen’s DM1 clinical program. You will serve as the statistical subject‑matter expert on our cross‑functional team with significant contribution to protocol development, study design, statistical analysis, regulatory submissions, publications and presentations, as well as managing CRO and external vendors.

Responsibilities

Lead the development of statistical sections of clinical study protocols, statistical analysis plans (SAP) and conduct the analysis and reporting of clinical trial data, including review of Tables, Listings, Figures (TLFs), SDTM and ADaM specifications, clinical study reports (CSR), and regulatory submission documents

Provide strategic input to optimize trial designs for pivotal registrational studies; maintain advanced competencies in statistical methodology and innovative trial designs, particularly in therapeutic areas such as neuromuscular diseases or other rare diseases, familiarity with ICH, FDA, and EMA guidelines

Representing the biostatistics function, proactively collaborate with internal and external cross‑functional teams to ensure timely statistics deliverables; oversee CRO statistical activities and effectively manage contractors and vendors

Contribute to the development of Biostatistics SOPs and standards

Effectively communicate complex statistical concepts in written and verbal context to a broad audience

Qualifications

Minimum of MS required (Ph.D. strongly preferred) in Biostatistics, Statistics, or other related fields with 8+ years of overall experience in drug development in the pharmaceutical industry

Experience in therapeutic areas such as neuromuscular diseases or other rare diseases preferred

Knowledgeable about a broad range of statistical topics in different phases of drug development, including efficacy, safety, and PRO endpoints and innovative study designs

Regulatory (s)NDA/BLA/MAA submission experience strongly preferred

Must have hands‑on experience with SAS and R programming in clinical trials

Experience with managing CROs and contractors

This role could be in‑person or remote (if remote, occasional travel to the HQ office in Boston, MA, will be required).

Compensation

The estimated full‑time salary range for this role is between $228,000 to $250,000. The final compensation package offered to a successful candidate will reflect a number of factors including but not limited to prior experience, relevant skills, education, qualifications and certifications, business needs, internal equity, and market data.

PepGen provides eligible employees a comprehensive and competitive total compensation package including but not limited to a discretionary annual bonus, equity, health insurance (including medical, dental, and vision), life and disability insurance, paid time off with paid holidays, paid parental leave, a 401(k) plan, cell phone reimbursement, student loan repayment or 529 contributions, and a lifestyle spending account.

About PepGen

PepGen is a clinical‑stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide (EDO) platform is founded on over a decade of research and development and leverages cell‑penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates designed to target the root cause of serious diseases.

For more information, please visit PepGen.com. Follow PepGen on LinkedIn and X.

EEO Statement

PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectionate or sexual orientation; disability; veteran or military status or liability for military status.

Recruitment & Staffing Agencies

PepGen does not accept unsolicited agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited. Thank you.

E-Verify

PepGen is an E-Verify Employer. For more information about E-Verify, please see here.

#J-18808-Ljbffr","
The Director, Biostatistics will work in collaboration with the Head of Biometrics to provide strong statistical support to advance PepGen’s ...","Director, Biostatistics",[589],{"_458":459,"_454":590,"_452":591,"_456":534,"_460":535},"WorkFromHome","WorkFromHome, MA, United States, 02298",["B","1980752653"],"Work at OSI","/jobs/1980752653-director-biostatistics","WorkFromHome, MA, United States","/jobs?keyword=OSI","/jobs?location=WorkFromHome%2C+MA%2C+United+States","/jobs?keyword=Director%2C+Biostatistics",{"_435":434,"_439":600,"_470":471,"_462":584,"_248":601,"_446":602,"_433":434,"_113":587,"_437":199,"_438":199,"_472":471,"_448":199,"_449":603,"_431":605,"_473":593,"_436":117,"_488":606,"_478":607,"_490":587,"_491":540,"_493":596,"_495":542,"_497":598},["D",1774026000000],"The Director, Biostatistics will work in collaboration with the Head of Biometrics to provide strong statistical support to advance PepGen’s DM1 clinical program. You will serve as the statistical subject‑matter expert on our cross‑functional team with significant contribution to protocol development, study design, statistical analysis, regulatory submissions, publications and presentations, as well as managing CRO and external vendors.

Responsibilities

Lead the development of statistical sections of clinical study protocols, statistical analysis plans (SAP) and conduct the analysis and reporting of clinical trial data, including review of Tables, Listings, Figures (TLFs), SDTM and ADaM specifications, clinical study reports (CSR), and regulatory submission documents

Provide strategic input to optimize trial designs for pivotal registrational studies; maintain advanced competencies in statistical methodology and innovative trial designs, particularly in therapeutic areas such as neuromuscular diseases or other rare diseases, familiarity with ICH, FDA, and EMA guidelines

Representing the biostatistics function, proactively collaborate with internal and external cross‑functional teams to ensure timely statistics deliverables; oversee CRO statistical activities and effectively manage contractors and vendors

Contribute to the development of Biostatistics SOPs and standards

Effectively communicate complex statistical concepts in written and verbal context to a broad audience

Qualifications

Minimum of MS required (Ph.D. strongly preferred) in Biostatistics, Statistics, or other related fields with 8+ years of overall experience in drug development in the pharmaceutical industry

Experience in therapeutic areas such as neuromuscular diseases or other rare diseases preferred

Knowledgeable about a broad range of statistical topics in different phases of drug development, including efficacy, safety, and PRO endpoints and innovative study designs

Regulatory (s)NDA/BLA/MAA submission experience strongly preferred

Must have hands‑on experience with SAS and R programming in clinical trials

Experience with managing CROs and contractors

This role could be in‑person or remote (if remote, occasional travel to the HQ office in Boston, MA, will be required).

Compensation\nThe estimated full‑time salary range for this role is between $228,000 to $250,000. The final compensation package offered to a successful candidate will reflect a number of factors including but not limited to prior experience, relevant skills, education, qualifications and certifications, business needs, internal equity, and market data.

PepGen provides eligible employees a comprehensive and competitive total compensation package including but not limited to a discretionary annual bonus, equity, health insurance (including medical, dental, and vision), life and disability insurance, paid time off with paid holidays, paid parental leave, a 401(k) plan, cell phone reimbursement, student loan repayment or 529 contributions, and a lifestyle spending account.

About PepGen\nPepGen is a clinical‑stage biotechnology company advancing the next generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide (EDO) platform is founded on over a decade of research and development and leverages cell‑penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates designed to target the root cause of serious diseases.

For more information, please visit PepGen.com. Follow PepGen on LinkedIn and X.

EEO Statement\nPepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectionate or sexual orientation; disability; veteran or military status or liability for military status.

Recruitment & Staffing Agencies\nPepGen does not accept unsolicited agency resumes. The company will not be responsible for any fees related to resumes that are unsolicited. Thank you.

E-Verify\nPepGen is an E-Verify Employer. For more information about E-Verify, please see here.

#J-18808-Ljbffr\n","The Director, Biostatistics will work in collaboration with the Head of Biometrics to provide strong statistical support to advance PepGen’s DM1 cl...",[604],{"_458":459,"_454":532,"_452":533,"_456":534,"_460":535},["B","1985837253"],"10 days ago","/jobs/1985837253-director-biostatistics","actionData","errors"]

Key Responsibilities

Qualifications

Key Responsibilities

Responsibilities

Qualifications

Compensation

About PepGen

EEO Statement

Recruitment & Staffing Agencies

E-Verify