Consultant I, Medical Writing

<div class="content-intro"><p><strong><u>COMPANY DESCRIPTION:</u></strong> </p>

<p>A career here is life-enhancing.</p>

<p>At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success. To learn more about who we are and what drives us, watch our company video <a href="

<p>Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.</p>

<p>Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. </p>

<p>At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. </p>

<p>For more information, visit <a id="menur1aj1" class="fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn" href=" target="_blank"> style="text-decoration: underline;"><strong>POSITION OVERVIEW:</strong></span></p>

<p><span class="NormalTextRun SCXW18505091 BCX8">T</span><span class="NormalTextRun SCXW18505091 BCX8">he MWS Consultant </span><span class="NormalTextRun SCXW18505091 BCX8">I </span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW18505091 BCX8">plays</span><span class="NormalTextRun SCXW18505091 BCX8"> a critical role in authoring and managing regulatory documents, </span><span class="NormalTextRun SCXW18505091 BCX8">supporting client</span><span class="NormalTextRun SCXW18505091 BCX8"> regulatory strategies, and ensuring high-quality deliverables that align with client expectations and </span><span class="NormalTextRun SCXW18505091 BCX8">regulatory</span><span class="NormalTextRun SCXW18505091 BCX8"> standards. </span><span class="NormalTextRun SCXW18505091 BCX8">This role </span><span class="NormalTextRun SCXW18505091 BCX8">is responsible for</span><span class="NormalTextRun SCXW18505091 BCX8"> leading document development efforts, coordinating regulatory projects, and collaborating with cross‑functional teams to meet diverse client needs across varying stages of development. The MWS Consultant serves as both a technical contributor and project owner, ensuring document accuracy, submission readiness, and adherence to regulatory requirements while </span><span class="NormalTextRun SCXW18505091 BCX8">maintaining</span><span class="NormalTextRun SCXW18505091 BCX8"> strong client relationships and delivery excellence.</span></p>

<p><span style="text-decoration: underline;"><strong>WORK LOCATION:</strong></span></p>

<p><span class="TextRun SCXW225455334 BCX8" lang="EN-US" data-contrast="auto"><span class="NormalTextRun SCXW225455334 BCX8">The MWS Consultant I position is eligible for remote work based on company requirements, with no minimum in-office </span><span class="NormalTextRun ContextualSpellingAndGrammarErrorV2Themed SCXW225455334 BCX8">requirement</span><span class="NormalTextRun SCXW225455334 BCX8">.</span></span><span class="LineBreakBlob BlobObject DragDrop SCXW225455334 BCX8"><span class="SCXW225455334 BCX8"> </span><br class="SCXW225455334 BCX8"></span></p>

<p><span style="text-decoration: underline;"><strong>KEY RESPONSIBILITIES:</strong></span></p>

<p>(This list is not exhaustive and may be supplemented or changed as necessary.)</p>

<ul>

<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="1" data-aria-level="1"><span data-contrast="auto">Author a variety of regulatory documents, including Clinical Study Reports (CSRs), study protocols, and client submission materials.</span><span data-ccp-props="{"134233279":false,"201341983":0,"335559740":240}"> </span></li>

</ul>

<ul>

<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="2" data-aria-level="1"><span data-contrast="auto">Lead the development of complex modules (e.g., Module 2 summaries, Briefing Documents, Orphan Drug, Fast-Track, and Breakthrough Designation applications).</span><span data-ccp-props="{"134233279":false,"201341983":0,"335559740":240}"> </span></li>

</ul>

<ul>

<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="3" data-aria-level="1"><span data-contrast="auto">Apply quality control and submission-readiness processes to deliver high-quality documents within agreed client timelines.</span><span data-ccp-props="{"134233279":false,"201341983":0,"335559740":240}"> </span></li>

</ul>

<ul>

<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="4" data-aria-level="1"><span data-contrast="auto">Serve as a project owner by tracking timelines, adjusting schedules, and coordinating with clients to address evolving demands.</span><span data-ccp-props="{"134233279":false,"201341983":0,"335559740":240}"> </span></li>

</ul>

<ul>

<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="5" data-aria-level="1"><span data-contrast="auto">Plan for and anticipate project challenges, update visual timelines, and maintain adherence to deadlines.</span><span data-ccp-props="{"134233279":false,"201341983":0,"335559740":240}"> </span></li>

</ul>

<ul>

<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="6" data-aria-level="1"><span data-contrast="auto">Facilitate client interactions, including meetings, inquiries, and feedback discussions, while building and maintaining client trust.</span><span data-ccp-props="{"134233279":false,"201341983":0,"335559740":240}"> </span></li>

</ul>

<ul>

<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="7" data-aria-level="1"><span data-contrast="auto">Ensure consistency, accuracy, and alignment across documents with client updates and applicable regulatory standards.</span><span data-ccp-props="{"134233279":false,"201341983":0,"335559740":240}"> </span></li>

</ul>

<ul>

<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="8" data-aria-level="1"><span data-contrast="auto">Collaborate with cross-functional teams to ensure the quality and accuracy of regulatory documents.</span><span data-ccp-props="{"134233279":false,"201341983":0,"335559740":240}"> </span></li>

</ul>

<ul>

<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="9" data-aria-level="1"><span data-contrast="auto">Contribute to the development of regulatory strategies for early-stage and smaller clients.</span><span data-ccp-props="{"134233279":false,"201341983":0,"335559740":240}"> </span></li>

</ul>

<ul>

<li data-leveltext="" data-font="Symbol" data-listid="1" data-list-defn-props="{"335552541":1,"335559683":0,"335559684":-2,"335559685":720,"335559991":360,"469769226":"Symbol","469769242":[8226],"469777803":"left","469777804":"","469777815":"hybridMultilevel"}" data-aria-posinset="10" data-aria-level="1"><span data-contrast="auto">Provide guidance on tools, document management systems, and client SOPs.</span><span data-ccp-props="{"134233279":false,"201341983":0,"335559740":240}"> </span></li>

</ul>

<ul>